CDSCO Test License for Medical Devices in India

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:

  1. Create an account on the NSWS portal and register.
  2. Apply for approval using Form MD-16 for import or Form MD-12 for manufacture.
  3. Upload all necessary documents.
  4. Pay the prescribed fee.
  5. 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:

  1. Brief description of the medical device, including intended use, material of construction, and design.
  2. Justification of the proposed quantity
  3. Test protocol/Approved clinical investigation plan
  4. Quality certificates such as QMS
  5. Labels and Instructions for Use (IFU)
  6. Undertaking stating the use of the medical device for non-commercial purpose.
  7. 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.

Contact us for all regulatory needs.

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

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:

  1. Form MD-1 Application for grant of certificate of registration of a notified body.
  2. Form MD-12 Application for license to manufacture medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training.
  3. Form MD-16 Application for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training.
  4. 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:

  1. Simplifying and centralizing the identification of required approvals through an intuitive approval finder based on business details.
  2. Providing clear application forms and checklists outlining exactly what submission documents are mandated by central / state agencies (including CDSCO).
  3. Allowing fully digital application submission, including online payments, rather than physical paperwork submissions.
  4. 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.

Contact us for all your regulatory needs.

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

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

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

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 01st 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:

  1. CDSCO Medical Device Registration
  2. CDSCO Medical Device Import License
  3. Wholesale License/Distributor License for medical devices
  4. Post Approval Changes in Medical Device
  5. Medical Device Label Compliance Review

Ready to navigate the regulatory landscape?

Contact us today to script your success story with RSI.

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 1st 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.

The Vital Role of Post-Marketing Surveillance for Medical Devices

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.

Medical Device Labelling: Ensuring Clarity and Safety

Introduction:

In the world of healthcare, medical devices play a crucial role in diagnosis, treatment, and patient care. At the same time ensuring their proper identification, usage, and safety is of paramount importance. This is where medical device labelling steps in, providing essential information to healthcare professionals and patients alike. In Chapter VI of MDR 2017, The Ministry of Health and Family Welfare (MoHFW) of India has outlined the labelling requirements for medical devices, underlining the significance of clear and informative labelling in the healthcare industry. These regulations, integrated within the larger framework of the Medical Devices Rules, 2017, go beyond being a mere legal obligation. They are a strategic approach towards enhancing patient safety, ensuring proper usage, and facilitating effective healthcare delivery.

Importance of Medical Device Labelling:

Medical device labelling serves as a bridge of communication between manufacturers, healthcare providers, and patients. It goes beyond branding to convey critical information about the device, its purpose, usage instructions, and manufacturer details. Accurate and comprehensive labelling ensures the proper identification, handling, and administration of medical devices, thereby contributing to patient safety and effective healthcare delivery.

Key Labelling Requirements:

According to the Medical Device Rule 2017, specific details must be included on the labels of medical devices:

  1. Device Identification: The device's name, batch number, or serial number for identification.
  2. User-Friendly Information: Essential details for users to identify the device and understand its use.
  3. Manufacturer/Importer Information: Manufacturer's/Importer’s name, address, and manufacturing premises.
  4. Quantity and Metrics: Correct statement of net quantity, expressed in weight, measure, volume, or units.
  5. Manufacturing/Import license number: The manufacturing/import license number for all locally manufactured/imported medical devices.
  6. Manufacturing Date and Expiry: Month and year of manufacture, and expiry or shelf life information.
  7. Medicinal or biological substance: If applicable, label should indicate that the device contains medicinal or biological substance.
  8. Sterilization Details: For sterile devices, the date of sterilization or recommended shelf life.
  9. Free sample for medical professional: If the device is intended for distribution to medical professionals as a free sample then the label must be overprinted with the words “Physician’s Sample- Not to be sold”.
  10. Special Storage Conditions: Indications of any required storage or handling conditions.
  11. Batch or Lot Number: A distinctive batch or lot number for traceability.
  12. Sterile State and Method: Indication of the device's sterile state and sterilization method.
  13. Warnings and Precautions: Relevant warnings or precautions for users' attention.
  14. Single-Use Indication: Labelling for devices intended for single use.

Labelling for Evaluation and Clinical Investigations:

Medical devices intended for clinical investigation, evaluation, testing, or training purposes must also be appropriately labelled. This includes details such as the product's name, batch or lot number, manufacturing date, use-before date, storage conditions, manufacturer's information, and the purpose for which it was manufactured.

The Legal Metrology (Packaged Commodities) Rules 2011

In addition to the labelling requirements as mentioned in the MDR 2017, the label must also meet the requirements as specified in the “Legal Metrology (Packaged Commodities) Rules, 2011” (LM rules) and amendments thereof. Related FAQ’s for this act can be found here.

Conclusion:

Medical device labelling is more than just printing information on a package – it's a cornerstone of patient safety, healthcare efficacy, and regulatory compliance. Accurate and comprehensive labelling empowers healthcare professionals to make informed decisions, enhances patient trust, and contributes to the seamless functioning of the healthcare ecosystem. As the landscape of medical devices continues to evolve, robust labelling practices remain at the forefront of ensuring the highest standards of care and safety. Medical Device labels must comply to requirements as prescribed in the MDR 2017 and LM rules (and their amendments thereof).

Consult Regulatory Solutions India for Your Labelling Compliance:

With over 12 years of invaluable experience in the regulatory domain, Regulatory Solutions India stands as a trusted partner. Our track record speaks volumes, with over 450 medical products successfully registered. What's more, we've garnered satisfied clients from more than 15 countries, underscoring our global reach and impact.
For all your regulatory needs, including labelling compliance, Regulatory Solutions India is your go-to resource. Contact us today to elevate the effectiveness of your healthcare endeavors. Your success is our commitment.

FAQ’s

1. What is the role of medical device labelling in healthcare?

Medical device labelling serves as a vital means of communication between manufacturers, healthcare providers, and patients. It provides essential information about the device's purpose, usage instructions, and manufacturer details, contributing to patient safety and effective healthcare delivery.

2. What are the key requirements for medical device labelling?

According to the Medical Device Rule 2017, medical device labels must include details such as device identification, manufacturer information, quantity and metrics, manufacturing date and expiry, sterilization details, storage conditions, warnings, batch or lot number, sterile state indication, and more. In addition, medical device labels must comply to LM Rules requirements.

Medical Device Grouping: An Effective Regulatory Approach

Introduction:

In the dynamic world of medical devices, regulations play a critical role in ensuring patient safety and product efficacy. The Government of India, recognizing the need to streamline the licensing process for medical devices, introduced the concept of “medical device grouping” as part of the Medical Device Rule, 2017 (MDR 2017). The primary aim of this concept is to simplify the process of applying for a license, making it faster and more cost-effective. To shed light on this important aspect of medical device regulations, this blog will explore what medical device grouping is and the various types of groupings as outlined by the Ministry of Health and Family Welfare (MoHFW) through its guidelines released-on March 16, 2018 and subsequent FAQ’s published on this important topic.

What is Medical Device Grouping?

Medical device grouping involves categorizing medical devices based on shared purposes or similar technology. This allows applicants to combine devices with the same intended use or common technology and apply for a single license for import or manufacturing. This not only simplifies the license application process for manufacturers and distributors but may also help reduce the applicable government fees depending on the grouping type, as explained in the next section.

Types of Medical Device Grouping:

The guidelines provided by the MoHFW offer clarity on how medical devices can be categorized and grouped for the license application. Here are the different types of grouping and their significance:

1. Single:

A single medical device refers to a distinct packaged item that does not fit into any other grouping category, such as families, systems, or group. Each single device requires its own separate fee and documentation. An example of this would be a company selling one single type of BP monitoring machine.

2. Family:

A medical device family includes devices from the same license holder with the same risk classification, common intended use, and similar design and manufacturing processes provided they have variations within the permissible scope. The family is licensed as a whole, and there is a single fee for the entire group. For instance, contact lenses with added UV protection can be grouped as a family since the additional feature does not alter the fundamental design and manufacturing process.

3. System:

A system refers to a combination of medical devices from the same license holder, intended to be used together for a common purpose.

If components of the system are used in more than one system, then they should be included in the application for each of those systems. Separate fees and documentation may apply based on how the system is sold. For example, a hip replacement system comprising femoral and acetabular components can be licensed as a system.

4. Group:

A medical device group consists of two or more devices sold together in a single package by the same license holder, serving a common purpose. The devices in the group may have different names, intended purposes and manufacturers. If a device in a group is used in another group, it should be included in the application for that other group. An example of this would be a first aid kit comprising medical devices such as bandages, gauzes, drapes, and thermometers, assembled together as one package for a common medical purpose by a product owner.
For a group of medical devices, a single fee is applicable (for the highest risk class product in the Group), and documentation is required for each device in the group.

Conclusion:

The introduction of medical device grouping is a commendable initiative by the Ministry of Health and Family Welfare (MoHFW), significantly enhancing the application process for medical device licenses. It not only simplifies and expedites the licensing process, but also makes it more cost effective for the license applicant. For further information on medical device grouping and regulatory matters, feel free to contact Regulatory Solutions India.

FAQ’s

1. What is medical device grouping?

Medical device grouping involves categorizing devices based on shared purposes or technology. It allows applicants to apply for a single license for devices with similar use or technology, simplifying the application process while making it cost-effective for the license applicant.

2. How are medical devices grouped?

Devices can be grouped as “Single,” “Family,” “System,” or “Group.” Each category has specific criteria and implications for licensing.

3. What is the difference between a Family and a Group?

A Family includes devices with the same risk classification, intended use, and manufacturing process, licensed together. In contrast, a Group may comprise multiple devices from different manufacturers sold together for a common purpose, even if they have different names and intended uses.

4. How can medical device grouping benefit manufacturers?

Medical device grouping simplifies the license application process, reducing costs as multiple devices can be grouped into one (when possible) and reduces application preparation time for importers/ manufacturers.

Understanding the Validity and Renewal of CDSCO Medical Device Import License

Introduction :

As per the Medical Device Rule, 2017, the medical device import license in India needs to be renewed every five years from the date of issuance. The manufacturers/Importers who obtained their medical device import license in 2018 during the initial phase of the Medical Device Rule's 2017 implementation are scheduled to expire in 2023. In this blog, we will take you on a journey through the CDSCO medical device import license renewal process and provide you with the guidance you need.

How to Obtain a CDSCO Medical Device Import License in India?

Acquiring a CDSCO medical device import license in India involves a meticulous and time-consuming process that entails comprehensive documentation. Follow these essential steps to obtain the import license for your medical device:
Step 1: Register yourself on Sugam Portal.
Step 2: Pay the fee prescribed by CDSCO.
Step 3: Submit online application in Form MD-14 with the required documents.
Step 4: The Concerned Authority will review your application and supporting documents. If found satisfactory, they will issue an import license in MD Form-15.

For more information on the process of registration and obtaining a medical device import license in India, read our blog on “The Complete Guide to CDSCO Medical Device Registration.

Understanding the Validity and Renewal Process:

According to the Medical Device Rule of 2017, the import license remains valid perpetually unless cancelled or voluntarily surrendered. To ensure its ongoing validity, the license holder must pay the retention fee and submit updated documents to the Central Drugs Standard Control Organization (CDSCO), the government agency responsible for regulating medical devices in India.

The license holder is required to pay this fee for each overseas manufacturing site and each licensed medical device before every five years from the date of issuance. If payment is not made within the specified timeframe, there is an additional 90 days to pay, albeit with a late fee of two percent per month. Failure to pay the retention fee within the given period results in the license being considered cancelled.

Renewing the medical device import license requires two steps:
1. Pay the retention fee.
2. Submit the updated documents.

CDSCO Medical Device License Application and License Renewal Process

Documents Required for Medical Device Import License Renewal:

The following documents are required for CDSCO medical device import license renewal:

1. Covering letter with purpose of application.
2. Details of Base license and endorsement license, if any.
3. List of products to be removed (if applicable) with reasons.
4. Requisite Fees breakup basis the product class and manufacturing sites.
5. An undertaking by the manufacturer, that there is no change in Device master file (DMF) and Plant master file (PMF).
6. Post marketing surveillance data (Vigilance reporting) during last 5 yrs.
7. Valid Free Sale Certificate/Marketing Authorization from the country of origin (if any) and from any of the following countries viz USA, EU, UK, Canada, Japan, Australia.
8. Sales data of each device in India during last 5 yrs.
9. Valid copies of Quality Certificate ISO 13485 and applicable EC design certificates.
10. An undertaking by the manufacturer and authorized agent, stating that they are agreed for further retention of the Import License.
11. Details of Post Approval Change Application, If Any.

Import License Retention Fee:

The retention fees for the import license vary depending on the type and class of the medical device. Here's a breakdown of the retention fees:




Retention Fee Table


S.R. No.Types of DevicesRetention Fee
1.One overseas site, Manufacturing Class A medical device (excluding in vitro diagnostic)$1000
2.One overseas site, Manufacturing Class B medical device (excluding in vitro diagnostic)$2000
3.One overseas site, Manufacturing Class C or Class D medical device (excluding in vitro diagnostic)$3000
4.Each distinct Class A medical device (excluding in vitro diagnostic)$50
5.Each distinct Class B medical device (excluding in vitro diagnostic)$1000
6.Each distinct Class C or Class D medical device (excluding in vitro diagnostic)$1500
7.One overseas site, Manufacturing Class A or Class B in vitro diagnostic medical device$1000
8.One overseas site, Manufacturing Class C or Class D medical device (excluding in vitro diagnostic)$3000
9.Each distinct in vitro diagnostic medical device of Class A or Class B$10
10.Each distinct in vitro diagnostic medical device of Class C or Class D$500


Conclusion:

Renewing your medical device import license is crucial to comply with the requirements of the Medical Device Rule of 2017. The renewal process involves paying the retention fee and submitting the updated documents. Regulatory Solutions India can assist you with the renewal process and ensure that your license remains valid.

Contact us today to learn more about our services and discover how we can support you in meeting your regulatory requirements.

FAQ’s

Q-1 What is MD Form-14?

MD Form-14 is an online application form for obtaining a medical device import license in India.

Q-2 In which form is a medical device import license issued in India?

The medical device import license in India is issued in the form of MD 15. The license is valid perpetually as long as the applicant pays the retention fee.

Q-3 What is the validity of an import license issued for MD 15 in India?

The import license issued for MD-15 in India is valid indefinitely as long as the retention fees are paid, and updated documents are submitted every five years.

Transitioning to Full Licensing: Class C and D Medical Devices in India

Introduction:

On April 12, 2023, the Central Drugs Standard Control Organization (CDSCO) of India released a circular reminding Indian manufacturers and importers that all Class C and Class D non-notified medical devices, currently under mandatory registration, will require a full license starting October 1, 2023. This blog will provide you with an overview of the new licensing regime and assist you in transitioning to the new license requirements.

Full License Requirement for Class C and Class D non-notified medical device

It is important first to understand what is meant by a non-notified medical device. These are medical devices which have fallen under the ambit of the licensing regime after the adoption of the new enlarged definition for Medical Devices by Ministry of Health & Family Welfare in Feb 2020. (Not sure whether your device is non-notified or not? We can help)

This full license requirement deadline is the final step for transiting the Class C & Class D non-notified medical devices to the Licensing regime.  Currently, all class C and D non-notified medical devices are exempt from Manufacturing/Import licence and can be manufactured/ imported into India basis their mandatory registration with CDSCO. From October 1, 2023, for such devices, it will compulsory to have a license if you want to introduce your medical device in India.

For medical device importers:

Getting a CDSCO medical device import license in India can take up to six months post the submission of application. The preparation for the application submission is also a time-consuming process and can easily take 1-3 months depending on the level of preparedness of an organization. Hence, it is important that all Class C and Class D non-medical device importers apply for the import license at the earliest to avoid any business disruption post 1st Oct 23.

For medical device manufacturers:

Similarly, obtaining a medical device manufacturing license in India is a time consuming process involving not only the extensive documentation but also an inspection by a Medical Device Officers of the Central Licensing Authority (CLA) within 60 days of application submission. Hence, if you have not started the application process, there is an urgency to do so now to maintain business continuity.

Conclusion:

The transition from mandatory registration to manufacturing/import license for Class C and D non-notified medical devices is the final step towards the full licensing regime for such devices. Manufacturers/importers need to be aware of the new regulation and take proactive steps to obtain a manufacturing/ import license. Given that CDSCO can take up to 6 months to issue a license there is an urgent need for impacted importers/manufacturers to start their application process immediately, if not done till now. Timely compliance will not only avoid disruption in the supply chain but also ensure continued access to these medical devices for patients.

Why Choose Regulatory Solutions India for your regulatory compliance needs?

When it comes to your regulatory compliance needs, Regulatory Solutions India (RSI) stands out as a trusted and reliable choice. With over 12 years of experience and a track record of success since its establishment in 2011, RSI has effectively registered over 400 products in various categories, including medical devices, IVDs, and cosmetics. The satisfaction of our clients from 15+ countries is a testament to our commitment to excellence. With a team of seasoned regulatory professionals, we are well-equipped to handle all your compliance requirements. Our expertise extends to providing technical, strategic, and project management support to ensure your success. Whether you require assistance with CDSCO medical device registration, import licensing procedures, post-approval changes, or dossier preparation, RSI is here to help.

Don't hesitate to contact us for all your regulatory compliance needs.

FAQ

What are Class C and Class D medical devices in India?

According to the Medical Device Rule of 2017, medical devices in India are classified into four categories: Class A, Class B, Class C, and Class D, based on their intended use, level of risk, and other factors. Class C and Class D medical devices are considered to have a moderate to high risk and are subject to stricter regulatory requirements compared to Class A and Class B medical devices.