The Complete Guide to CDSCO Medical Device Registration

The Indian healthcare sector is rapidly expanding and is expected to reach $280 billion by 2025. The medical device market in India is one of the top twenty in the world. It currently has an estimated value of $11 billion, and by 2025, it is anticipated to grow astoundingly. India does not manufacture many medical devices on its own and still imports roughly 70% of its medical devices. Medical device manufacturing and monitoring are highly regulated activities. The Central Drugs Standard Control Organization (CDSCO) introduced the Indian Medical Device Rules, 2017, to regulate medical devices, which were previously governed by the Drugs and Cosmetics Act of 1940.
To ensure full compliance in the rapidly evolving regulatory landscape, it's essential to not only understand CDSCO registration but also how to acquire a medical device manufacturing license in India. This additional step enables manufacturers to contribute directly to India's burgeoning healthcare sector.

The Central Drugs Standard Control Organization (CDSCO), is the National Regulatory Authority (NRA) of India and reports to the Ministry of Health & Family Welfare's Directorate General of Health Services.

CDSCO is responsible for the approval of New Drugs/Medical Devices/Cosmetics, the Conduct of Clinical Trials, laying down the necessary standards, control of the quality of imported Drugs/Medical Devices/Cosmetics in the country, and coordination of the activities of the State Drug Control Organizations.

CDSCO registration is necessary, in the case of:

• Clinical trial and new drug approval
• Licenses for imports of medical devices
• Manufacturing medical devices
• Vaccines, certain medical devices, and blood banks
• Changes to the laws governing cosmetics and medications, as well as any related rules
• Participation in GMP certification programs run by the WHO
• Issuing personal licenses, export NOCs, and test licenses

Medical devices are manufactured in a highly regulated environment and must adhere to strict regulatory requirements and guidelines because they are concerned with the health and safety of the patients. There has been a lot of activity recently in the Indian regulatory system for medical devices. The MDR, which was published in January 2017 and went into effect in January 2018 followed by the “Medical Devices (Amendment) Rules, 2020" published in February 2020 and went into effect in April 2020. The MDR (amendment) 2020 and related notification aimed to cover all medical devices being manufactured/imported and defined the steps for transiting to the new licensing regime. The definition, thus adopted, is closely aligned with the existing definition for medical devices as per Europe and Singapore regulations.

Medical devices are generally classified according to their risks; the actual risk-based classification of the medical device is determined by its intended use and purpose. The new system has established four classes (Class A, B, C, and D), with Class A and B devices posing the lowest risk and Class C and D devices posing the highest risk to patients. For example-

• A (Low Risk)- Absorbent cotton wools, alcohol swabs, etc.
• B (Low-Moderate Risk)- Blood Pressure monitoring device, thermometer, disinfectants, etc.
• C (Moderate-High Risk)- Implants, hemodialysis catheter, etc.
• D (High Risk)- Heart valve, Angiographic guide wire, etc.

CDSCO guidelines state that the following parties can register medical devices under CDSCO-

• The manufacturer who has a registered office in India;
• The authorized representative of the manufacturer;
• The manufacturer's subsidiary;
• Importer;
• Domestic manufacturer

Medical devices entering India must comply with the CDSCO's Indian Medical Device Regulation. CDSCO has established a comprehensive procedure for issuing licenses for medical devices imported into the country. This procedure is followed when medical devices are imported into India from other countries. They must, however, be classified according to the CDSCO notified devices list. The Central Drugs Standard Control Organization has prescribed the following forms for importers to obtain a medical device import license.

In general, for an importer who wishes to obtain a medical device import license for pre-existing goods, CDSCO has prescribed “Application Form: MD -14” and the authorization to import is received in “Form: MD -15”.
These forms are for all risk categories from A to D. (Some medical devices may also require a Compulsory Registration prior to obtaining the Import License).

In the event that an importer wishes to obtain an import license for new medical devices for which predicates do not exist, CDSCO has prescribed “Application Form: MD -26” and the approval is received vide “Permit Form: MD -27”

These forms are for all medical devices that fall under the categories from A to D.

The Ministry of Health and Family Welfare proposed an amendment to the Medical Device Registration Act in 2020 that required all importers and manufacturers of medical devices—aside from the 37 categories of medical devices previously notified—to register with the Central Licensing Authority through a designated portal made possible by the CDSCO. Currently, in order to register a medical device under the CDSCO regime, the following steps must be taken-
The Importer or Manufacturer or their agent in India must submit an application for the CDSCO Medical Device Import License about the facilities & devices manufactured by the Manufacturer and intended for import into India as per following steps:

Step 1: Indian agents register themselves on the SUGAM online portal.

Step 2: Fees are to be paid online as prescribed by CDSCO for the manufacturing site and the proposed devices.

Step 3: Application to be submitted online in Form MD-14 along with the following information:

• Information About the Applicant
• Product Information
• Power of attorney
• Relevant certificates
• Device and Site Master File

Step 4: The concerned Department will issue the Medical Import License in Form MD-15 once all the aforementioned steps have been completed and documents found satisfactory.

Additionally, it's important to note that the Medical Device Import License in India is initially valid for 5 years and requires renewal every 5 years from its date of issuance.

A Medical Device Import License in India under CDSCO is subject to a slew of requirements and documentation. Such requirements and documentation may be difficult to discern fully by an applicant and any mistakes in the documentation or application process could result in costly delays. As a result, it is strongly advised that you contact Regulatory Solutions India, and we will walk you through each step of the licensing process. Regulatory Solutions India, with our extensive experience in medical devices registrations, help make the process easier for our esteemed clients across the complete lifecycle starting with the application preparation and ending with the successful registration of the medical device.