Union health ministry has notified draft Medical Devices (MD) Amendment Rules, 2021 to allow more time to medical device manufacturers to comply with the ISO 13485 certification by November 30, 2021 from the earlier timeline of September 30, 2021. The ISO certification is a prerequisite to secure registration for medical devices as part of the licensing process.
The voluntary registration was supposed to be completed by September 30, 2021 timeline granted earlier by the Drugs Controller General of India (DCGI) to the medical device manufacturers.
According to a union health ministry earlier notification of February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till the end of September, 2021.
The Draft Medical Devices Amendment Rules, 2021 notified by the Ministry has proposed insertion of a proviso and explanation, under the Rule 19 B, in subrule (2), in item (iii), where in the Rules, it is stated that the certificate of compliance in respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of the medical devices, has to be uploaded for registration on the online system for medical devices, established by the Central Drugs Standard Control Organisation (CDSCO).
The notification further states, “Provided that in case the applicant submits, on or before the November 30, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the May 31, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.
For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the May 31, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice.”
In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:— “may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the May 31, 2022, thereafter it shall be mandatory for all registration holders”.
In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—“Provided that in case the applicant submits, on or before the November 30, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the May 31, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.
For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the May 31, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice.”
In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:— “may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the May 31, 2022, thereafter it shall be mandatory for all registration holders”.
As per the union health ministry notification, the following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board (DTAB) is hereby published for information of all persons likely to be affected thereby.
Notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified will be considered by the Central Government.