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The term ‘Registration’ in this notice is referring to the process under Chapter III A of Medical Device Amendment Rules 2020 and is the same as ‘voluntary registration’ available from April 1, 2020 to September 30, 2021 (18 months). The ‘compulsory registration’ is the same and will be available from October 1, 2021 to October 1, 2022 (for Class A and B) and up to 01 October 2023 (for Class C and D).
India Temporarily Suspends Compulsory Medical Device Registrations
Published on: October 5th, 2021
Seeks to Maintain Uninterrupted Access to Meet Healthcare Market Needs
In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date. The CDSCO has directed Drugs Controllers (and Port Officials) to allow uninterrupted supply of medical devices, and access to patients until the MOHFW makes a decision on the various representations submitted by the stakeholders. The notice was addressed to all State/Union Territory Drugs Controllers, CDSCO Port offices, and Zonal and Sub-Zonal CDSCO offices. Once the Ministry announces a revised date of implementation, it will be “compulsory” to register online, with no importation being allowed until the registration has been completed.
How to Avoid Market Access Interruption
Manufacturers wishing to avoid market access interruptions should immediately become compliant with their products’ registration requirements, whether it’s an MD-15 Import License or a Registration. Products falling into one of the CDSCO’s 23 Notified product categories of medical devices must obtain an Import Licenses before importing. All other products require a Registration, which is an immediate process that is granted once the product’s information is submitted through their e-portal. Originally, the CDSCO October 1, 2021, the CDSCO being the first day all medical devices will need to be registered before importation. All Class A and B devices will require an Import License by October 1, 2022, and October 1, 2023 for Class C and D.
Product information needed for the non-notified medical device registration:
- Name of the company or firm or any other entity importing the medical device
- Details of medical such as the generic name, intended use, classification, material, shelf life, etc.
- Specification and standards of that medical device, ISO 13485 certificate
- Free sale certificate from country of origin
- Declaration of Conformity
Manufacturers of medical devices belonging to a Notified product category need to submit an Import License and more information can be found here.
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