Who can apply to import an Investigational medical device in India?

Indian manufacturers or authorized agents of foreign manufacturers holding a MD-42 license can apply to import investigational medical devices in India.

Medical Device - Regulatory Solutions India

Materiovigilance Programme of India (MvPI) :DCGI Calls for Strengthening Medical Device Adverse Event Reporting

Posted on July 15, 2024July 16, 2024 by Abhishek Patel

The Drugs Controller General of India (DCGI) has called for the timely reporting of adverse events related to medical devices by issuing a circular dated May 15, 2024. The move aims to strengthen the existing Materiovigilance Programme of India (MvPI) ensuring that medical devices are safe and reliable once in the market.

What does the Circular state?

The Materiovigilance Programme of India (MvPI) is an important programme for reporting adverse events, coordinated analysis related to medical devices, including in-vitro diagnostic devices, therefore it is suggested that all the license holders should also use the MvPI platform to report any adverse events/serious adverse events associated with the devices to enhance the procedure of identifying risk associated with medical devices.

What is MvPI?

The Materiovigilance Programme of India (MvPI) was launched by the Ministry of Health and Family Welfare, Government of India, on July 6, 2015, with the objective to monitor, record and analyse the root cause of adverse events or risks associated with the use of medical devices, including in-vitro diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies to take appropriate action to improve Indian patients’ safety. Indian Pharmacopeia Commission (IPC) is functioning as National Coordination Center (NCC) for MvPI.

Objectives of MvPI:

The core objectives of MvPI are as follows:

To promote the reporting of adverse events related to medical devices by clinicians, biomedical engineers/clinical engineers, hospital technology managers, pharmacists, nurses, technicians, medical-device manufacturers.
To collect adverse event reports, assess them, and submit medical device reports to the medical device regulator.
Voluntary registration of medical device manufacturers to:
Report adverse events, associated.
Root cause analysis and corrective/prevention action to IPC-NCC.
To develop and implement an electronic reporting system (e-reporting).
To support the health system where in procurement of medical device is only undertaken after studying adverse events associated with the medical device intended for procurement.
To make it mandatory, in the long term, – for all healthcare providers under the Clinical Establishment Act to report adverse events associated with medical devices.

Important Responsibilities under MvPI:

Medical device organisations, including in-vitro diagnostics, are important stakeholders to make the MvPI programme a success. The key responsibilities of such organisations as a result of the MvPI are as follows:

Robust Post-Market Surveillance: Post-market surveillance refers to the vigilance on the use of medical devices, including the information on the quality, safety. or performance of medical devices after the medical device is placed on the market. With a robust post-market surveillance system, organizations can reduce, -the chances of adverse events that may lead to any harm/ injury to the patient. Moreover, the regular vigilance process reduces the likelihood of the same type of adverse incident being repeated in different places at different times.
Reporting of Medical Device Adverse Event: In case an adverse event or incident related to a medical device has been noticed by the manufacturer or healthcare service provider, or Medical Device Adverse Event Monitoring Centers (of public/private hospitals), it should be reported immediately, and its root cause of failure should be investigated and intimated to IPC-NCC.
Reporting of Field Safety Corrective Action: A field safety corrective action (FSCA) notification form has been developed to notify the regulatory authority and the consignees regarding any corrective action or recall that has been initiated by the manufacturer/importer to reduce any serious adverse reaction associated with the use of medical devices. Concerned organizations must take cognizance of this form and use it for reporting their FSCAs.

Materiovigilance Programme of India (MvPI)

Benefits of MvPI:

It is crucial for providing secured, sensible and responsible healthcare to citizens in India.
It contributes to establishing a system in India for systematic, scientific and practical means of screening large medical device adverse events datasets at the national level.
It contributes to public health by identifying potential safety issues more accurately and quickly.
It promotes patient safety by identifying adverse events that could result in patient harm.
It encourages Medical Device Manufacturers/ Importers to put products in market with a sense of ethical business, analyze and improve design and performance of products.
It can provide supportive data to improvise product standards developed by ISO/BIS.

Conclusion:

MvPI is a critical components of India's healthcare delivery system, guaranteeing the safety and efficacy of medical devices while increasing healthcare quality. Prioritizing transparency and employing cutting edge technology can create an efficient Materiovigilance system which can protect public health while improving healthcare quality.
For more information on India's Materiovigilance Programme and its effect on medical device safety, visit, https://www.ipc.gov.in/mandates/materiovigilance-programme-of-india-mvpi/about-us.html.

How can Regulatory Solutions India Help You?

Regulatory Solutions India (RSI) is your reliable partner when it comes to medical device regulation. Since 2011, they have successfully registered over 450 products ranging from medical devices, IVDs and cosmetics across 25+ categories such as stents, catheters, intraocular lenses, orthopedic implants, ablation devices surgical dressings, hypodermic syringes/needles and more from clients from 15+ countries.

RSI provides its clients with a unique combination of technical, strategic and project management support backed by rich industry experience. We help companies register their products with India's central licensing authority (CDSCO) while offering expert knowledge into CDSCO medical device registration and import license processes in order to navigate successfully the regulatory landscape.

Why Choose RSI?

Regulatory Strategy for Medical devices: Analyse the portfolio, interpret regulatory requirements, identify potential problems, and design the right strategy for medical devices accordingly.
Regulatory Application Submission to CDSCO: Review regulatory documents, validate dossiers and submit applications for Import License.
Registration Approval: Technical support for scientific meetings with regulators and for responding to regulatory queries.
Post Registration Support: It also offers post registration support in labeling recommendations & regulatory compliance, post registration compliance reporting obligations and advise on impact, if any, due to regulatory changes.

Take Action Today

Partner with Regulatory Solutions India to ensure the safety and security of the medical devices. Visit us here.

Intraocular Lenses and Regulatory Processes

Posted on June 12, 2024July 16, 2024 by Abhishek Patel

Intraocular Lenses (IOLs) are special lenses put inside the eye during surgery to replace the natural lens. This often happens when someone has cataract surgery, but they can also be used for other vision correction surgeries.

What Are Intraocular Lenses (IOLs) Regulatory Processes?

IOLs are artificial lenses made from clear plastic, silicone, or acrylic. They help people see better by focusing light onto the retina, just like the natural lens in our eyes. Unlike contact lenses that sit on the eye’s surface, IOLs are implanted inside the eye.

Types of Intraocular Lenses

There are different types of IOLs for different vision needs:

1. Monofocal IOLs: These lenses have one focusing distance, usually for clear distance vision. You might still need glasses for reading or close-up work.

2. Multifocal IOLs: These lenses provide multiple focal points, so you can see clearly at different distances (near, intermediate, and far). This reduces the need for glasses.

3. Toric IOLs: These lenses help people with astigmatism, which is when the cornea is curved unevenly.

4. Accommodative IOLs: These lenses move or change shape inside the eye, offering a more natural range of vision.

5. Extended Depth of Focus (EDOF) IOLs: These lenses provide a continuous range of vision with one elongated focal point, offering better intermediate vision without causing glare or halos.

Intraocular Lenses (IOLs) and Regulatory Processes in India

Uses of Intraocular Lenses

IOLs are used in several situations:

● Cataract Surgery: The most common use of IOLs is to replace the natural lens when it becomes cloudy due to cataracts.

● Refractive Lens Exchange (RLE): This surgery is similar to cataract surgery but is done to correct vision problems like near-sightedness, far-sightedness, and presbyopia.

● Phakic Intraocular Lens (PIOL): These lenses are implanted without removing the natural lens to correct high levels of near-sightedness or far-sightedness.

In India, the Central Drugs Standard Control Organization (CDSCO) regulates IOLs. Here’s what you need to know about the approval process:

Regulatory Approval for Intraocular Lenses in India

In India, the Central Drugs Standard Control Organization (CDSCO) regulates IOLs. Here’s what you need to know about the approval process:

Classification of Intraocular Lenses

As per the risk-based classification of medical devices under the Medical Device Rules (MDR), IOLs are classified under Category C, which means they are considered moderate-to-high risk devices.

Regulatory Pathway

● CDSCO Registration: All IOLs must be registered with the CDSCO. This includes submitting clinical data, technical details, and manufacturing information.

● Licensing: Manufacturers and importers need licences to manufacture or import IOLs.

● Clinical Evaluation: Clinical trials might be needed to prove that IOLs are safe and effective.

● Quality Management Systems: Compliance with standards like ISO 13485 is necessary to ensure safety and quality.

How RSI Helps in the Regulatory Process?

Regulatory Solutions India (RSI) is a leading regulatory consultancy in India that assists companies with medical device regulations. Our team comprises experts experienced in the regulatory requirements for medical devices, including IOLs. Here's how we can help:

Preparing and submitting regulatory documents
CDSCO Registration/Licensing
Submission of IL renewal/retention applications
Post-market surveillance and compliance

Conclusion:

Understanding the rules and steps for getting approval for intraocular lenses in India can be challenging, but with the right help, it becomes easier. Knowing about the regulatory requirements is key for successful market entry. RSI has helped several companies over the years register their products over a wide range of applications, some of which are Ophthalmic, Neurological, General Hospital, Respiratory, Dental, Ear, Nose and Throat (ENT), Obstetrical and Gynecological (OG), Software, Operation Theatre (OT), Gastroenterological, Oncology and more.

By working with Regulatory Solutions India (RSI), you can ensure compliance and focus on bringing your IOL’s and other medical devices to market.

CDSCO Update: New Online PSUR Guidelines in India

Posted on May 9, 2024July 16, 2024 by manager

The Central Drug Standard Control Organization (CDSCO) has recently made a change to how safety reports for medical devices and in-vitro diagnostic devices are submitted in India. Starting on March 19, 2024, all manufacturers have to submit these reports online through the Sugam portal. This new method is meant to make things easier and more organized. In this blog, we'll talk about why these reports are important, what they should include, and how to submit them.

What is a Periodic Safety Update Report (PSUR)?

Periodic Safety Update Reports (PSURs) are crucial reports, applicable to investigational medical devices, (i.e. devices without predicate) that manufacturers/importers of such medical devices need to submit to demonstrate how their products are performing after they have been sold. These reports are a key part of Post-Market Surveillance (PMS), a practice that monitors the safety and performance of investigational medical devices on the market.

What should be included in PSUR?

A PSUR should have several parts that give a full picture of how a medical device is doing. Broadly, the MDR 2017 recommends that a PSUR to be structured as follows:

Introduction: Complete with the device details (intended use, mode of operation, etc.) , the reporting interval and description of the intended population.
Current worldwide marketing authorization status: Details of countries, where the device is approved, and/or countries where it is withdrawn with reasons thereof.
Action taken in reporting interval for safety reasons: Description of any significant safety actions during the reporting period.
Changes to reference safety Information: Any significant changes to reference safety information.
Estimated patient exposure: Estimates of size and nature of the population using the device, and detailed case histories of any problems people have had with it.
Presentation of individual case histories: Individual case information available to a license holder including brief case narrative, medical history indication, causality assessment etc.
Studies: Summaries of new safety findings that may affect device safety information.
Other Information: This should include details about the risk management plan.
Overall Safety Evaluation: Summary of the safety concerns, benefit evaluation and Risk-benefit analysis along with the safety profile of the medical device.

Who Needs to Submit PSURs?

The companies that manufacture/import the investigational medical devices are the ones who need to prepare and send these reports. It’s important they do a good job of making sure the reports are accurate and sent on time.

When and How to Submit a PSUR

Here’s when and how to send these reports:

For the First Two Years: A report needs to be sent every six months.
For the Next Two Years: After that, a report is needed once a year.
Longer If Needed: Sometimes, more reports might be needed based on health needs.
All reports should now be sent online through the Sugam portal, which helps keep everything in order and easy to manage.

Conclusion:

Periodic Safety Update Reports are more than just paperwork—they’re crucial for keeping investigational medical devices safe after they are sold. By carefully looking at safety information, companies and regulators can make decisions that keep everyone safe and ensure devices work as they should. This ongoing monitoring is key to keeping trust in medical technology high.

At Regulatory Solutions India (RSI), we specialize in providing regulatory consultancy services for medical devices If you need help navigating the submission process or ensuring compliance with the latest regulations, contact us.

FAQ’s

1. What is a PSUR, and why is it important for medical device manufacturers?

A Periodic Safety Update Report (PSUR) is a crucial report that investigational; medical device importers/manufacturers submit to demonstrate how their products are performing after they’ve been sold. It’s essential because it helps monitor the safety and performance of devices post-market, ensuring they remain safe and effective for patient use.

2. What information should be included in a PSUR?

A PSUR should include details such as the device’s intended use, where it’s approved for sale, any safety actions taken, updates to safety information, estimates of device usage, research findings, and an overall safety review.

3. Who is responsible for submitting PSURs, and when should they be submitted?

The responsibility for submitting PSURs lies with the companies that manufacture/import such investigational medical devices. PSURs should be submitted every six months for the first two years post-marketing, then annually for the next two years. Additional submissions may be required based on health needs.

4. How has the submission process for PSURs changed in India?

As of March 19, 2024, the Central Drug Standard Control Organization (CDSCO) has mandated that all manufacturers/importers submit PSURs online through the Sugam portal. This change aims to streamline the submission process and ensure greater organization.

5. Why are PSURs considered crucial for maintaining trust in medical technology?

PSURs are more than just paperwork—they play a critical role in keeping investigational medical devices safe after they're sold. By carefully monitoring safety information and addressing any issues promptly, companies and regulators can uphold the trust of patients and healthcare professionals in medical technology.

CDSCO Test License for Medical Devices in India

Posted on April 15, 2024July 16, 2024 by manager

Chapters IV and V of the MDR 2017 provide detailed guidelines for manufacturers and importers seeking to manufacture or import small quantities of medical devices for specific purposes in India. These licenses enable companies to conduct clinical investigations, testing, evaluation, demonstrations, or training without the need for full manufacturing or import licenses. In this article, we provide an in-depth overview of the test license regulatory process, eligibility requirements, steps involved, necessary documentation, validity, cancellation conditions, and the benefits associated with obtaining a test license.

Eligibility for Medical Test License:

Any importer or manufacturer aiming to import or manufacture small amounts of medical devices for testing, evaluation, demonstration, or training purposes must obtain a test licence approved by the Central Drugs Standard Control Organization (CDSCO). For commercial purposes, a full import or manufacturing licence is required.

Steps to Apply for Test License:

Create an account on the NSWS portal and register.
Apply for approval using Form MD-16 for import or Form MD-12 for manufacture.
Upload all necessary documents.
Pay the prescribed fee.
CDSCO will review the application form and issue a test license in Form MD-17 for import or Form MD-13 for manufacture if found satisfactory.

Documents Required:

Brief description of the medical device, including intended use, material of construction, and design.
Justification of the proposed quantity
Test protocol/Approved clinical investigation plan
Quality certificates such as QMS
Labels and Instructions for Use (IFU)
Undertaking stating the use of the medical device for non-commercial purpose.
Undertaking from the testing laboratory confirming the provision of required facilities.

Steps to Obtain CDSCO Medical Test Licence

Applicable Fees:
1. Test license for manufacture: 500 Rs for each distinct medical device
2. Test license for import: 100USD for each distinct medical device

Validity: The test license remains valid for 3 years from the date of issue.

Cancellation of Test License: If a licensee contravenes any provisions of the rules, the Central Licensing Authority may issue a show cause notice for cancellation. The licensee has the right to appeal to the Central Government within forty-five days from the date of the cancellation order.

Benefits:
1. Facilitates innovation while ensuring compliance with regulatory standards
2. Allows companies to do product testing/ clinical investigation prior to market introduction.
3. Provides opportunity for companies to conduct internal trainings prior to full-scale commercial launch.

Conclusion:

Obtaining a test license for medical devices in India is essential for companies engaging in testing, evaluation, demonstration, or training activities. By adhering to regulatory standards and obtaining expert guidance, companies can navigate the licensing process effectively and contribute to advancing healthcare innovation in India.

Why RSI ?

Regulatory Solutions India (RSI) provides comprehensive regulatory consulting services to assist companies in obtaining test license for medical devices in India. With expertise in eligibility criteria, documentation preparation, submission, and compliance with regulatory requirements, RSI can streamline the licensing process, mitigate risks, and accelerate market entry of your medical device in India.

FAQ’s

Test License For Manufacturing:

1. What records does the licensee need to maintain under the test license for manufacture?

The licensee must keep a detailed record of the quantity of products manufactured under the test license.

2. How should the medical device be used under the test license for manufacture?

The medical device manufactured under the test license should be used exclusively for clinical investigations, tests, evaluations, examinations, demonstrations, or training at the specified location mentioned in the license.

3. Can Medical Device Officers inspect the manufacturing premises?

Yes, Medical Device Officers have the authority to enter the manufacturing premises, with or without notice, to ensure that only authorised activities are being conducted.

4. What other records are required to be maintained by the licensee?

The licensee should maintain records of the quantity of medical devices manufactured, tested, and stocked, along with their disposition.

Test License For Import:

1. How should the medical device be used under the test license for import?

The medical device imported under the test license should be used exclusively for clinical investigations, tests, evaluations, demonstrations, or training at the specified location mentioned in the license.

2. Can the medical device be taken to places other than those mentioned in the test license?

No, if the medical device needs to be taken to a place other than those specified in the license, written permission must be obtained from the Central Licensing Authority.

What activities should the holder of the test license maintain records of?

The holder of the test license must maintain records of activities undertaken, including the name of the manufacturer, quantity imported, and date of import.

4. What documents should accompany the consignment of medical devices?

The consignment of medical devices should be accompanied by an invoice or statement showing the name and quantity of the medical devices.

5. What should be done with unused medical devices?

Unused medical devices, including in vitro diagnostic medical devices, may be exported or destroyed with intimation to the Central Licensing Authority.

NSWS portal: A Single Window for Central Government Approvals

Posted on March 14, 2024July 16, 2024 by manager

The Central Government has launched the National Single Window System (NSWS) portal for businesses/investors seeking to enter or operate in the Indian market . It serves as a single window where more than 600 central and 6000 state approvals and clearances. The objective behind launching this online NSWS portal is to provide an efficient and transparent system for advising emerging and existing business on applicable clearances and approval.

In this blog we provide a quick guide to the process flow for submitting applications on this portal and also the CDSCO approvals currently incorporated therein for medical devices.

Using the NSWS Portal: Your Easy Guide to Approvals

Getting Started: Any business can create an account on the NSWS portal by providing basic company information to create a profile. The portal features a handy tool called “Know Your Approvals'' which asks questions about planned business activities and then identifies the regulatory approvals likely required. You can add these approvals to your dashboard for easy tracking.

Applying for Approvals: The portal offers straightforward digital application forms for various central government approvals. Mandatory fields are indicated in the forms, and some information may auto-populate from your profile. Helpful tooltips explain what information is needed in each field. Progress can be saved, allowing for completion of applications at a later time.

Uploading Documents: Relevant checklists assist in identifying the documents needed to support each application. Users simply browse their computer and upload files directly to the portal. Standardized formats are available for download if certain documents must follow a template.

Final Review & Fees payment: Upon completion, the portal allows users to review the full application and make edits. The applicable fee is also indicated at this stage and the applicant can proceed to pay the same.

Application Submission: The final legal form is digitally signed using a Digital Signature Certificate (DSC) and submitted to the government department for processing and approval.

Tracking Applications: Post the application submission the portal provides a running status update on all applications, allowing users to monitor their progress. Users also have the option to submit additional documents if requested by the reviewing authority.

Services Available on the NSWS Portal for Medical Devices Industry:

Currently, the NSWS portal provides the following approvals/registrations for the medical device industry:

Form MD-1 Application for grant of certificate of registration of a notified body.
Form MD-12 Application for license to manufacture medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training.
Form MD-16 Application for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training.
Form MD-39 Application for grant of registration to medical device testing laboratory for carry out test or evaluation of a medical device on behalf of manufacturer.

As the NSWS portal is in an early stage, CDSCO is constantly adding more approval and registration services to the portal. It is recommended to keep an eye on the official NSWS portal for updated services.

Benefits of the NSWS Portal:

The NSWS portal offers several benefits including:

Simplifying and centralizing the identification of required approvals through an intuitive approval finder based on business details.
Providing clear application forms and checklists outlining exactly what submission documents are mandated by central / state agencies (including CDSCO).
Allowing fully digital application submission, including online payments, rather than physical paperwork submissions.
Enabling real-time tracking of application status through online dashboards for better consultant support.

Conclusion:

The NSWS portal aims to streamline and bring consistency to India's business approval process through a single unified platform. Its online tools help demystify regulatory requirements, making it easier for both Indian and foreign companies to invest in and operate within the country.

About Regulatory Solutions India (RSI):

With over 12 years of expertise in successfully navigating the regulatory landscape of healthcare product registration in India, Regulatory Solutions India (RSI) stands as a reliable partner. RSI specialises in hand holding clients along the complete regulatory approval process cycle, ensuring compliance, and supporting businesses in bringing their medical innovations to the dynamic Indian healthcare market.

Image Source – Official CDSCO Notification

FAQs:

What is the NSWS portal, and how does it simplify the medical device approval process in India?

The NSWS portal is a Single Window System launched by the central government which acts as a one-stop shop for all approvals required by investors and facilitates ease of doing business.

Can any business easily create an account on the NSWS portal, and what information is required?

Yes, any business can create an account by providing basic company information to create profile on the NSWS portal.

How does the "Know Your Approvals" tool assist businesses in obtaining regulatory clearances?

The tool asks questions about planned business activities and identifies the approvals required, providing a clear roadmap for businesses.

What services and approvals are currently available on the NSWS portal for the medical device industry?

The NSWS portal currently offers various central and state related approvals. For the most up-to-date information and new services, businesses are recommended to regularly visit the official NSWS portal.

What are the key benefits of using the NSWS portal for medical device approvals in India?

The benefits include simplified identification of required approvals, clear application forms, fully digital submission, and real-time tracking of application status, making the process efficient and user-friendly.

CDSCO Approval Process for Medical Devices without predicate in India

Posted on February 13, 2024July 16, 2024 by manager

The Indian medical device market is growing rapidly, and the current medical device market size is estimated at $11 billion and is expected to reach $50 billion by 2025. This presents an opportunity for manufacturers and importers to launch their medical devices in India.
The Regulatory approval pathway for a Medical Device without predicate can have variations and hence can be a bit complex to navigate through. In this blog, we will guide you through the overall process to get approvals for such devices.

What is a Medical Device without predicate?

Let us first understand what is meant by a predicate device.

The Medical Device Rules define a predicate as “a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India”

Thus a Medical device without predicate will be one which does not have a similar device as defined above in the Medical Device Rules 2017.

Regulatory Pathway for Approval of Medical Devices without predicate:

1. Clinical Investigation: Manufacturers/Importers must conduct clinical investigation to establish safety and efficacy as per rules set by India’s Central Drugs Standard Control Organization (CDSCO), specifically under Chapter VII of the Medical Device Rules 2017. Application must be made in Form MD-22 and approval is granted in MD-23. There are some exceptions to clinical investigation requirements by CDSCO which we will discuss below.

2. Clinical Investigation exceptions for Class B, C & D: Chapter VIII of the MDR 2017 specifies that, clinical investigation may not be required to be submitted where

the medical device without predicate is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan and
the said device has been marketed for at least two years in that country and
the Central Licensing Authority is satisfied with the data of safety, performance, and pharmacovigilance of the device and
there is no evidence of any difference in the behavior and performance in Indian population.

On compliance to the above conditions and a written undertaking by the applicant to conduct post marketing clinical investigation, as per protocol approved by the Central Licensing Authority, a clinical investigation may not be required prior to approval. There are a few additional exceptional situations prescribed therein e.g. national emergencies, epidemic etc. wherein the clinical data requirements may be abbreviated, deferred or omitted.

3. Test License & Clinical Investigation start: Obtain test License in MD-13 (for manufacturing) or MD-17 (for import) and conduct clinical investigation.

4. Apply for “Approval of Medical Device which does not have a predicate” (in Form-26) and Obtain Permission in Form MD-27 which would be subject to conditions as outlined in Chapter VIII of the MDR 2017.

5. Apply for Import/Manufacturing License: Subsequent to the Form MD-27, manufacturers/importers can apply for the Import License (in Form MD-14/ MD-3/7), submitting necessary documents.

6. Initiate Imports/Manufacture : Upon receiving the Import / Manufacturing License the import/manufacturing of the “medical device without predicate” can be initiated however at all times complying to the clinical investigation and other prescribed requirements specifically those in Chapter VII and VIII of the MDR 2017.

How to Get Permission for Conducting Clinical Trials:

1. Identify an Indian Clinical Research Organization (CRO): Choose an Indian CRO to manage and oversee clinical trials.
2. Submit Form MD-22 for Clinical Trial Permission: Prepare and submit Form MD-22 with supporting documents to CDSCO, requesting permission to conduct clinical trials.
3. Grant of ‘Permission to Conduct Trials’ (in Form MD-23): Upon successful review, CDSCO grants ‘Permission to Conduct Trials’ in Form MD-23.
4. Commence Clinical Trials After Ethics Committee Approval & CTRI Registration: Following Ethics Committee approval and Clinical Trials Registry – India (CTRI) registration, commence the clinical trials.

Conclusion:

Introducing a medical device not having predicate in India’s thriving market presents immense opportunities along with regulatory complexities. By following the step-by-step approval roadmap and securing import permissions, manufacturers/importers can realize significant benefits.

Additionally, support from an expert partner proves invaluable for compliance and commercial success. Regulatory Solutions India (RSI) offers 12+ years of experience in successfully registering healthcare products in India.

Contact Us today. RSI can guide your company through India’s device approval process smoothly. Partnering with RSI helps bring your medical innovations to patients in India’s fast-growing healthcare market.

FAQ:

What are the key requirements to introduce medical device without predicate in India?

The device having no comparable product i.e. predicate registered in India should undergo clinical trials for safety/efficacy, and obtain permissions in Form MD-27 by submitting the application in Form MD-26 along with supporting documents. Finally obtain the import /manufacturing license in Form MD-15 /MD-5 or MD-8.

Who can apply to manufacture or import an Investigational medical device in India?

Indian manufacturer or authorized agent of foreign manufacturer can apply to manufacture/import investigational medical devices in India.

What is Form MD-26?

Form MD-26 is the application that must be submitted to request permission to import or manufacture a medical device not having predicate in India.

What is Form MD-27?

Form MD-27 is the approval granted by India’s Central Drugs Standard Control Organization (CDSCO) if the Form MD-26 application is found satisfactory.

What fees are required to obtain permission in form MD-27?

The application fee is INR 50,000 to import or manufacture a medical device without predicate in India as per current regulations. Additional fees would be applicable for the clinical trials and the import license.

Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices

Posted on January 5, 2024July 16, 2024 by manager

Introduction:

In the ever-evolving landscape of the healthcare industry, ensuring the quality and safety of medical devices is paramount. To meet these stringent criteria and regulatory standards, manufacturers must conform to Bureau of Indian Standards (BIS) for their products. These standards, along with the Medical Device Rules, 2017, plays a pivotal role in ensuring that medical devices in India adhere to established quality benchmarks. In this quick guide, we'll explore the intricacies of BIS requirements for medical devices, its significance, and how it benefits both manufacturers and patients.

Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices

The foundation of medical device regulations in India lies in the Medical Device Rules, 2017. Within these rules, Rule 7 emerges as a linchpin that defines the product standards medical devices must meet. Under Rule 7:

1. Medical devices must conform to standards set by the Bureau of Indian Standards (BIS), established under the Bureau of Indian Standards Act, 1985.
2. In the absence of specific BIS standards, devices should adhere to standards specified by renowned international organizations such as the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC).

When no standard exists under the aforementioned provisions, devices must comply with validated manufacturer's standards.

It is important to emphasize here that MDR 2017 mandates conformance to BIS but a certification is not required.

Government Notification – Providing Clarity

The Government of India, through the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, issued a pivotal notification on February 1, 2022. This notification unveiled a comprehensive list of 1485 medical devices/equipment and the corresponding BIS standards that they need to conform to. It serves as a roadmap for manufacturers/importers, providing clear guidelines to align their products with stringent quality and safety standards.

Types of BIS Certifications Applicable in India (Not Specifically Medical Devices)

Manufacturers based on the product they are manufacturing will need following types of BIS Certification/registration:

1. Indian Standards Institution (ISI) (Scheme 1):

For ISI Certification, Bureau of Indian Standards (BIS) is responsible for granting the certification. This Certification, which is applicable for a wide range of products from chemical to electrical products, ensures that your product meet Indian Safety Standards. The ISI certification process includes manufacturing site inspection and product sample testing. The list of products covered under the ISI certification are available on their website.

2. Compulsory Registration Scheme (CRS) (Scheme 2):

The Compulsory Registration Scheme (CRS) is mandatory for certain electronic and IT equipment and to obtain the CRS Certificate, these products must clear the testing done in only BIS accredited labs. The list of products that require compulsory registration is made available on the BIS Site.

The Benefits of BIS Certification

BIS certification for products in India offers numerous benefits:

1. Legal Compliance: BIS certification is often mandatory for selling in India, ensuring manufacturers meet legal obligations and avoid potential penalties.
2. Quality Assurance: Certification signifies adherence to stringent quality and safety standards, assuring both manufacturers and consumers of rigorous testing and inspection.
3. Consumer Confidence: BIS certification enhances consumer trust in medical devices, indicating conformity to recognized quality standards.
4. Market Access: Certification facilitates market entry, streamlining product distribution in India.
5. Long-Term Viability: Certification encourages investment in research and development, fostering innovation and long-term viability.

Benefits of BIS Certification

Conclusion:

BIS certification is the key to ensuring compliance with rigorous quality and safety standards. The guidance provided by Rule 7 of the Medical Device Rule 2017 and the recent government notification on BIS standards empower manufacturers to navigate the regulatory landscape effectively. Regulatory Solutions India (RSI) stands as a trusted partner, offering over 12 years of experience in regulatory compliance and a track record of successful registrations for more than 450 medical products. Importers and Manufacturers can rely on RSI for expert guidance on BIS certification and comprehensive support for all regulatory needs.

Ready to Certify?

Contact RSI for Hassle-Free BIS Certification
Embark on your journey towards BIS certification and regulatory excellence today. Contact Regulatory Solutions India (RSI) to ensure your medical devices meet the highest standards of quality and safety, not just for compliance but for the well-being of patients and the success of your endeavors. Your commitment to quality begins with BIS certification.

FAQ’s

1: What is BIS certification in India?

BIS certification is a compliance requirement in India for products, ensuring they conform to established quality and safety standards.

2: Why is BIS certification essential for products?

BIS certification is crucial as it signifies legal compliance, quality assurance, and consumer confidence. It enhances market access, provides a competitive advantage, and paves the way for global recognition.

3: How do I know which BIS standards apply to my medical device?

The Government of India issued a notification on February 1, 2022, listing BIS standards for medical devices. Manufacturers can refer to this comprehensive list to ensure conformance

4: What role does Regulatory Solutions India (RSI) play in BIS certification?

RSI, with over 12 years of regulatory expertise, assists manufacturers in navigating the complex BIS certification process, ensuring conformance and facilitating market access.

5: How can I get started with BIS certification for my medical devices?

Initiate your BIS certification journey by contacting RSI, your trusted partner. Our experts will guide you through the process, ensuring your devices meet the highest quality and safety standards.

6-Month Extension Announced for Class C and Class D Medical devices

Posted on December 5, 2023July 16, 2024 by manager

On October 12, 2023, the CDSCO released a circular, extending the deadline by six months for manufacturers and importers dealing with non-notified Class C and Class D medical devices. Originally slated for mandatory licensing from October 1, 2023, this extension aims to smoothen the transition. In this article, we delve into the intricacies of the CDSCO circular and guide you through the approval procedures for Class C and Class D medical devices.

CDSCO Addresses the Industry Concern

The circular grants manufacturers and importers of class C and D devices a six-month grace period to continue operations seamlessly. The shift to a fully licensed regime has triggered concern in the medical industry, prompting fears of a potential shortage of medical devices. Various stakeholders voiced apprehensions about the disruption. Acknowledging these concerns, the CDSCO extended the mandatory licensing timeline, allowing those who applied for licenses on or before September 30, 2023, to import or manufacture devices for an additional six months from 01^st Oct 23.

Overview of the Registration and Licensing Process

The registration process for medical devices in India is intricate and demands substantial documentation. The CDSCO serves as the central authority, responsible for issuing import and manufacturing licenses for all medical devices. Here's a concise breakdown:

Import Licensing Procedure for Class C and D Medical Devices

– Register on the Sugam portal.
– Pay the prescribed fee.
– Submit an online application on Form-14 with required documents.
– Upon review and satisfaction, CDSCO issues an import license in Form-15.

Procedure for Issuing a Manufacturing License for Class C and D Medical Devices

– Register on the Sugam portal.
– Pay the prescribed fee.
– Submit an online application in Form MD-7 (or MD-8 for loan License) with the necessary documentation.
– Undergo an audit of manufacturing facility by Central Licensing Authority.
– Upon compliance and satisfactory inspection, receive the manufacturing authorization in Form 9 (or MD-10 for loan License).

Conclusion:

The CDSCO’s extension of the licensing period addresses the medical device industry’s concerns, aiming to prevent disruptions in the manufacturing and import of medical devices. This initiative ensures a smoother transition to the new approval regime.

How RSI Supports Class C and D Medical Device Licensing:

If you have still not submitted your application for Class C & D devices, we could assist you with the same. With over a decade of experience in the medical device regulatory domain, RSI has successfully registered 450+ medical devices across all categories and fostered success stories for clients from over 15 countries.

Explore RSI’s spectrum of services:

Ready to navigate the regulatory landscape?

FAQ’s

1. Who is eligible for the 6-month extension provided by CDSCO?

The extension applies to manufacturers and importers who applied for licenses before September 30, 2023, allowing them to continue importing or manufacturing devices for an additional six months from 1^st Oct 23.

2. What is Form-14 used for in the medical device licensing process?

Form-14 is an essential legal application form for obtaining an import license for medical devices in India. It requires submitting necessary documents alongside the application on the Sugam portal.

3. What is Form-15 in the import licensing procedure?

Form-15 is issued by the CDSCO upon a satisfactory review of Form-14, allowing the importation of medical devices into India once approved.

4. What is Form-7 in the medical device licensing process?

Form-7 is an essential application form used to obtain a manufacturing license for medical devices in India.

5. What is the significance of Form-9 in the medical device manufacturing process?

Form-9 is the permission granted upon satisfactory inspection and compliance, signifying the authorization for manufacturing Class C & D medical devices in India.

WPC ETA Certification – Must for Wireless Medical Device

Posted on November 6, 2023July 16, 2024 by manager

Introduction:

Medical devices incorporating wireless technologies require WPC Equipment Type Approval (ETA) certification to be imported or sold in India. This blog provides detailed guidance on the ETA certification process mandated by the Wireless Planning and Coordination (WPC) wing of the Department of Telecommunications.

What is WPC?

The Wireless Planning and Coordination (WPC) wing was established in 1952 under the Ministry of Communications. It serves as the National Radio Regulatory Authority in India with responsibilities for Frequency Spectrum Management, including licensing, to meet the requirements of all wireless users. WPC carries out the key functions of granting licenses for establishing, operating and maintaining wireless stations across the country.

Equipment Type Approval (ETA) Certification

ETA stands for Equipment Type Approval. It is a certification that wireless medical devices need to get from WPC. The ETA certificate means the wireless medical device model follows the standards and regulations in India.
Medical devices that use wireless technologies like Bluetooth, Wi-Fi, RFID, etc. need to have ETA. This is required if they operate in frequency bands marked as “license-exempt” in India.
Without an ETA certificate from WPC, wireless medical devices cannot be imported, sold, or used in the country. So, ETA certification is mandatory approval that wireless medical devices must get from WPC before launching in the Indian market.

Eligibility for ETA Certification

The WPC only grants ETA certificates to Indian manufacturers or agencies. Foreign manufacturers need to appoint an authorized Indian agency as their local representative to be able to apply for ETA on their behalf.

ETA Application Process:

The ETA application process mainly involves the following steps:

– Apply online on the WPC portal and submit the hard copy of the completed application form along with required documents to the WPC regional licensing office.

– For devices operating in de-licensed frequency bands, the approval process is online. For others, the routine submission procedure needs to be followed through the designated regional office.

– Once submitted, the WPC reviews and scrutinizes the application. If found satisfactory, the ETA certificate is issued.

ETA Application Process in 4 steps

Documentation Required:

To apply for ETA certification, medical device manufacturers are required to submit the following documents to WPC:

– Duly completed application form with technical details of the wireless medical device
– RF test reports obtained from an accredited laboratory recognized by WPC
– Relevant technical documents like user manuals, datasheets, design specifications
– Authorization letter from the original equipment manufacturer
– Application fee payment receipt of Rs.10,000 per model paid through the Bharat Kosh portal

ETA Certificate Validity:

Unlike many other approvals, ETA certificates do not have any defined validity period. Once issued, they are considered as lifetime approvals and no renewal is required unless there is a change to product configuration/structure or to a key component of the product.

ETA through Self-Declaration:

For wireless devices like mobile phones, routers, smart watches etc. that operate in license-exempt bands at very low power levels and are exempted from import licensing requirements, WPC has provisioned a simplified self-declaration procedure.

Applicants can submit their ETA application online through the Saral Sanchar portal along with payment receipt and required documents. The undertaking and test reports furnished by the applicant are considered for approval after screening, without additional verification testing.

RSI’s Assistance with ETA Certification

The ETA application process requires careful preparation and submission of documents as per WPC guidelines. Regulatory Solutions India (RSI) assists medical device companies with end-to-end support for securing WPC ETA certification in India which includes:

– Expert guidance on ETA licensing requirements for medical devices
– Support with product testing at WPC accredited labs
– Preparing and reviewing ETA application documents
– Online application submission and tracking
– Responding to WPC queries and follow-ups
– Securing ETA approval efficiently

With deep expertise in Indian medical device regulatory processes, RSI ensures a hassle-free ETA certification process for your wireless medical products in order to launch them swiftly in the Indian market. Partner with RSI for a smooth experience with WPC compliance and approvals.

FAQ’s

1. What is the process for obtaining ETA for wireless products not exempted from import licensing?

For products not exempted from import licensing like drones, ETA is still obtained through the routine process involving WPC's regional licensing offices. Applications can be submitted online to the concerned RLO as per the regular procedure.

2. What RF test report is required for ETA?

The RF test report issued by a WPC accredited lab for the product is required when applying for ETA. For imported products containing multiple RF modules, test reports for all modules without any modification need to be provided.

3. Can imported wireless modules get ETA through self-declaration?

Yes, wireless module imports are permitted under the self-declaration approach if they meet the dual criteria of a) being exempted from import licensing requirements, and b) operating in de-licensed frequency bands.

4. Is ETA needed for Indian manufactured products using approved modules?

For products manufactured in India using RF modules already holding ETA without any changes, fresh ETA is not required for the finished product. But imported finished products need ETA even if they contain approved modules.

5. Can ETA be used by any importer once granted?

Yes, once ETA is issued it can subsequently be utilized by any importer for the approved product without additional payment to WPC.

The Vital Role of Post-Marketing Surveillance for Medical Devices

Posted on October 13, 2023July 16, 2024 by manager

Introduction:

The use of medical devices has improved healthcare enormously. However, like any technology, medical devices also carry risks. These risks require vigilance. Post-marketing surveillance plays a key role in ensuring patient safety by monitoring devices after they are in clinical use. This article explores why post-marketing surveillance matters and how India is strengthening it through Medical Devices Regulations 2017 (MDR) and the Materiovigilance Programme (MvPI).

What is Post-Market Surveillance?

Post-market surveillance (PMS) refers to continuously monitoring the safety and efficacy of a medical device. This monitoring happens after the device enters the market and is in clinical use. It aims to promptly identify any issues or problems with the device so that appropriate corrective actions can be taken.

The Need for Post-Marketing Surveillance

When medical devices are tested during initial clinical trials, the sample sizes are small, and the duration is short compared to real-world long-term use. Hence, not all issues are identified prior to approval. Once the device is launched, it goes into varied patient populations and settings. Continuous PMS helps in picking up adverse events or device failures that happen at low frequencies or take time to manifest.

Some key benefits of medical device post-marketing surveillance are:

1. Identifying New Problems: Clinical trials have limited duration and patient sample size. Issues can emerge during long-term device use in diverse populations that pre-market trials cannot predict. Post-marketing surveillance allows proactively picking up adverse events not known earlier.

2. Understanding Underlying Causes: Investigating adverse events reveals failure modes and whether issues are device-related or due to use errors. Root cause analysis is key to finding solutions.

3. Informing Procurement Decisions: Systematically generated evidence on device safety performance enables making informed procurement choices. It prevents needless expenditure on devices with poor safety records.

4. Preventing the Recurrence of Issues: Analyzing event data helps identify recurrent problems. Alerts to hospitals can prevent similar adverse events. Manufacturers can implement corrections worldwide.

5. Improving Device Standards: Real-world data aids the revision of safety standards to address problematic device features or technology risks found post-marketing.

Key Benefits of Post Marketing Surveillance (PMS)

Enabling Design Improvements: Manufacturers can utilize surveillance insights to redesign products, improve materials and components, update software or strengthen cybersecurity.

Post-Market Surveillance: Requirements and Reporting

Post-market surveillance (PMS) ensures a medical device stays safe after being sold. The Medical Device Rules (MDR) 2017 outline PMS requirements and reporting in India. The important elements of Post-market Surveillance are as follows:

Complaint Handling System: Manufacturers/Local India agents must have a robust complaint handling system in place which includes Standard operating Procedures for handling complaints and preventive/corrective actions, etc.

Adverse Event (AE) and Serious Adverse Event (SAE): An Adverse Event (AE) is any event or other occurrence that reveals any defect in a medical device or concerns any adverse effect arising out of the use thereof. Whereas a serious adverse event means an untoward medical occurrence that leads to a death, or a serious deterioration in the health of the subject or foetal distress.

Field Safety Corrective Actions (FSCA): A field safety corrective action may include recalls, software upgrades, user notifications, added training etc. with an aim to reduce issues and ensure ongoing safety. In all such cases the manufacturers must promptly inform CDSCO of risks from devices that seem unsafe using the prescribed FSCA form for reporting.

Data Sources for PMS

1. Adverse event reports: Important safety data is gathered from adverse event reports associated with the use of the medical device. Manufacturers, healthcare providers, patients, and other stakeholders are required to submit reports of any adverse events or incidents. Analysis of these reports of problems or issues enables identifying risks and taking corrective actions to improve device safety. Adverse event reporting is a crucial component of medical device post-market surveillance.
2. Device registries: Device registries actively collect predefined clinical, technical and safety data on real-world use of a medical device type. This enables long-term monitoring of device performance and safety outcomes.
3. User complaints: Complaints reported by device users, healthcare providers, etc., are analyzed to identify potential issues with device performance or safety.
4. New clinical studies: Additional clinical studies conducted post-approval provide further evidence on safety and effectiveness in defined patient groups and settings.
5. Research publications: Ongoing review of published studies and reports helps identify emerging safety issues or risk factors associated with the device.
6. Returned faulty device analysis: Detailed analysis of returned faulty or failed devices helps determine the root causes and modes of failure.
7. Surveys, social media, sales data: Social media listening, market surveys, sales data analysis, etc., also provide supplementary data.

This data identifies risks, failure modes, patient impacts, and areas needing action. The goal is continuous monitoring to keep devices safe through collaborative work between manufacturers and regulators.

The Vital Role of Stakeholders

For post-marketing surveillance to work, a concerted effort is needed from all stakeholders:
– Healthcare professionals need to document and report any adverse events diligently.
– Hospitals must investigate failures and share data openly.
– Clinical/biomedical engineers are crucial for the technical investigation of incidents.
– Manufacturers need to undertake transparent root cause analysis.
– Regulators have to issue guidance and take data-driven actions.
– A culture of safety and ethics must underpin the system.

Investment in training, infrastructure, and efficient processes is required to realize the full benefits. Post-marketing surveillance is thus a collaborative endeavor for improving healthcare quality and outcomes.

The Materiovigilance Programme of India

Launched in 2015, MvPI aims to monitor device safety, guide policies and regulations, and promote safe use. The Indian Pharmacopoeia Commission is the National Coordination Center. Key aspects include:
– Monitoring adverse events and investigating signals
– Assessing device risks and causes of failures
– Communicating alerts and advisories
– Guiding regulatory controls and corrections
– Enhancing standards and manufacturer vigilance

MvPI has established vigilance monitoring centers throughout India and introduced an adverse event reporting form for gathering data from manufacturers, healthcare providers, and other stakeholders. Truly harnessing its potential requires active participation from all stakeholders.

Conclusion:

Post-marketing surveillance provides a valuable ongoing feedback loop for ensuring patient safety and optimizing medical device use. MvPI creates a robust surveillance infrastructure in India. But, realizing its potential requires the participation of all stakeholders. With a coordinated effort, post-marketing surveillance can enable proactive and preventive vigilance over the entire device life cycle.

Contact Us for Your Regulatory Needs:

Regulatory Solutions India is here for all your regulatory needs, including post-market surveillance. Let us guide you through the complex world of regulations and ensure that your medical devices are safe and effective. Your success in healthcare is our top priority.

FAQ’s

1: What is post-market surveillance for medical devices?

Post-market surveillance (PMS) is the continuous monitoring of the safety and efficacy of medical devices after they have entered the market and are in clinical use. It aims to promptly identify any issues or problems with the devices.

2: Why is post-market surveillance necessary?

Post-market surveillance is necessary because clinical trials conducted before a device's approval have limitations, such as small sample sizes and short durations. PMS helps identify issues that may arise during long-term use in diverse patient populations.

3: How is post-market surveillance conducted in India?

Post-market surveillance in India is outlined in the Medical Device Rules (MDR) 2017. It involves Field Safety Corrective Actions (FSCA), reporting adverse events, data collection, recalling unsafe devices, and gathering data from various sources like adverse event reports and user complaints.

4: What is the role of stakeholders in post-market surveillance?

Stakeholders, including healthcare professionals, hospitals, clinical engineers, manufacturers, regulators, and others, play a vital role in documenting, reporting, investigating, and taking corrective actions related to adverse events. Their collaborative efforts ensure the effectiveness of PMS.