“The Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.”

Gunjan Verma
Managing Partner
Asia Actual India

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India’s MOH Releases Draft Amendment to the Medical Device Rules 2017

Published on: February 4th, 2022

Changes Adjust Importer ISO 13485 Requirement Timeline

On 12^th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India. This comes on the heels of the 12^th October 2021 release of draft GSR 729 (E) w.r.t. amendment if Rules 19B, 19C, 19D and 19E of the Medical Device Rules, 2017 and can be found here. Last date to submit feedback is 4^th March 2022.

Proposed Changes to Rule 19B – ISO 13845 Requirements

The notification provides relaxation to Indian Manufacturers who currently do not have the ISO 13485 certification and may be in the process of certification. The manufacturer (refers to local or indigenous manufacturer in India) has to submit an undertaking on or before 28th February, 2022 confirming that they are in the process of seeking the ISO 13485 Certification. Further they have to be submit the ISO 13485 certification received before 31 May, 2022. A provisional registration number shall be generated in cases with no ISO 13485 and submission of undertaking, which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate, whichever is earlier.

If by 31 May 2022, the manufacturer fails to submit the ISO 13485 certification, then the provisional registration will be cancelled.

Proposed Changes to Rule 19C – Labeling Update for Local Manufacturers

Currently, the existing Rule requires Local/Indigenous Manufacturer include the registration number on the label of the medical device (immediately once generated). However, under the new rule, it would be optional until 01 June 2022. The current rule in the Medical Device (Amendment) Rules, 2022 has option provided to Manufacturer who may, if they so desire, mention the registration number or provisional registration number for a period up to the 31st May, 2022.

It will be mandatory for all registration holders to affix the VRN Number on the label of the medical device from 01 June 2022 forward.

Proposed Changes to Rule 19D – In Process ISO 13485 Certifications

Importers that do not already have ISO 13485 Certification, will have to provide assurances they are in the process on or before 28th February, 2022. They will then have to be submit the ISO 13485 certificate before the 31st May, 2022. A provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtains the ISO certificate.

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