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Date: 2021-09-21 Category: Not Applicable State: Union Government Country: India

Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification outlines the steps and documentation required for manufacturers and importers to register non-notified medical devices on the CDSCO online portal.
  • It details a phased approach to registration, starting with a voluntary period followed by mandatory registration, and eventually transitioning to a licensing regime based on the class of the medical device (A, B, C, or D).

Key Changes

  • Manufacturers and importers of non-notified medical devices must register on the CDSCO online portal (https://cdscomdonline.gov.in/NewMedDev/Homepage).
  • The registration process involves creating an account with a valid email ID and mobile number, uploading required documents, and verifying the registration via OTP.
  • Manufacturers must provide details such as company name and address, manufacturing site address, device specifics (generic name, model number, intended use, class, material, dimensions, shelf life, sterility, brand name), ISO 13485 certification, and a signed undertaking.
  • Importers must provide company name, device details (as above), device specifications and standards, ISO 13485 certification, a free sale certificate from the country of origin, and a signed undertaking.
  • Registration of Class A, B, C, and D devices was voluntary from April 1, 2020, to September 30, 2021.
  • Mandatory registration for Class A and B devices was in effect until September 30, 2022.
  • Class A and B devices will be subject to a licensing regime from October 1, 2022.
  • Mandatory registration for Class C and D devices is in effect from October 1, 2021, to September 30, 2023.
  • Class C and D devices will be subject to a licensing regime from October 1, 2023.

Impact Analysis

Manufacturers

  • Action Items: Ensure compliance with ISO 13485 standards to facilitate the registration process.

Importers

  • Action Items: Obtain free sale certificates from the country of origin for the medical devices being imported.

CDSCO (Central Drugs Standard Control Organization)

  • Action Items: Prepare for the transition to a licensing regime for Class A, B, C, and D devices.

Consumers

  • Action Items: Consumers can expect a higher level of scrutiny and quality control for medical devices, potentially leading to safer and more reliable products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the regulatory body responsible for medical device registration and regulation in India. ISO 13485: An internationally recognized standard for quality management systems specific to the medical device industry. National Accreditation Board for Certification Bodies (NABCB): An accreditation body that accredits certification bodies to ISO 13485 standard. International Accreditation Forum (IAF): A global association of accreditation bodies that ensures consistency and equivalence of accreditation services worldwide. Medical Devices: Non-notified medical devices of Class A, B, C and D as per the Medical Devices Rules, 2017.
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STEPS TO BE FOLLOWED BY THE MANUFACTURERS/ IMPORTERS FOR REGISTRATION OF NON-NOTIFIED MEDICAL DEVICES Step-1-> Follow the URL https://cdscomdonline.gov.in/NewMedDev/Homepage Step-2-> Applicant has to click on the registration link from the portal. Step-3-> Applicant has to register with a valid Email-id and Mobile No. Step-4->The applicants has to upload the following documents for registering on the portal:-  Id Proof Details  Undertaking  Corporate Address Proof Details (Certificate of Incorporation)  Copy of Manufacturing License and the Wholesale Licenses (If not then upload the justification for the same) Step- 5->The applicant has to verify the registration through the OTP (4 digits) received on the mobile. Step-6->After self-verification, the applicants can login and proceed further.Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices Documents required for Registration of medical devices by the Manufactures: - 1. Name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device 2. Details of medical device Generic Model Intended Class of Material of Dimension Shelf Sterile Brand Name No. Use Medical Construction Life or Non Name device Sterile 3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device 4. undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic Documents required for Registration of Medical Devices by the Importers: - 1. Name of the company or firm or any other entity importing the medical device 2. Details of medical device Generic Model Intended Class of Material of Dimension Shelf Sterile Brand Name No. Use Medical Construction Life or Name device Non Sterile 3. Specification and standards of that medical device 4. certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device 5. Free sale certificate from country of origin6. undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.  The registration of Class A, B, C & D devices has been kept voluntary for a period of 18 months w.e.f. 1st April 2020 i.e till 30.09.2021,  Voluntary Registration of Class A & B devices shall be followed by Mandatory Registration for 12 months after 18 months of Voluntary registration period is over i.e. up to 30.9.2022,  From 01.10.2022 Class A & B devices will fall under licensing regime.  Voluntary Registration of Class C & D devices shall be followed by mandatory registration for 24 months after 18 months’ Voluntary registration period is over i.e. 01.10.2021 to 30.9.2023  From 01.10.2023 Class C & D devices will fall under licensing regime.

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