How to register medical devices? CDSCO issues guidelines
New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has specified the documentation required for medical device registration by manufacturers and importers.
To begin, the CDSCO has issued the following steps for manufacturers and importers to follow in order to register 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.
In addition, the CDSCO outlined the following documents that manufacturers must submit in order to register medical devices:
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 Name | Model No. | Intended Use | Class of Medical device | Material of Construction | Dimension | Shelf Life | Sterile or Non Sterile | Brand Name |
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.
Furthermore, the CDSCO detailed the following documentation that must be submitted by importers in order to register medical devices:
1. Name of the company or firm or any other entity importing the medical device
2. Details of medical device
Generic Name | Model No. | Intended Use | Class of Medical device | Material of Construction | Dimension | Shelf Life | Sterile or Non Sterile | Brand Name |
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 origin
6. undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.
In addition to this, the notification further added;
• 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.
To view the official notice, click the link below:
Also Read: CoSara Diagnostics gets CDSCO clearance for chikungunya, dengue tests
