Gunjan Verma - India

“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.”

Gunjan Verma
Managing Partner
Asia Actual India

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Registration

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:

  1. Name of the company or firm or any other entity importing the medical device
  2. Details of medical such as the generic name, intended use, classification, material, shelf life, etc.
  3. Specification and standards of that medical device, ISO 13485 certificate
  4. Free sale certificate from country of origin
  5. 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.

Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia and with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests in India.

Blog Posts

China’s NMPA Updates Medical Device Classification Catalogue

China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.

Thai FDA Drafting New Guidance for SaMD and AI Device Registration

Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.

China NMPA Adds 47 Products to Clinical Trial Exemption List

China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.