In a relief to the medical devices industry, especially the micro, Small and Medium Scale Enterprises (MSME), the Union ministry of health and family welfare is planning to relax the norms related to registration of medical devices with the regulator by allowing more time to comply with the ISO 13485 certification, which is a prerequisite to get the registration.
This comes at a time when the majority of the medical devices manufacturers complained that they could not get the registration done within September 30, when the timeline for voluntary registration ended, due to difficulties in getting the ISO certification amidst C-19 pandemic and related disruption.
A draft amendment rules notified by the Ministry, 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 draft amendment rule adds a provision that in case the applicant submits, on or before November 30, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before May 31, 2022, in lieu of certificate of compliance, a provisional registration number shall be generated.
This will remain valid up to May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The generated provisional registration number shall be valid for all purposes.
The draft further explains, “For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before 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.”
Further, under the Rule 19 C, instead of the condition that the company “shall mention the registration number” on the label of the medical device. This has been amended by substituting it with the condition that the manufacturer may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period of up to May 31, 2022. After this date, it shall be mandatory for all registration holders to mention the registration number on the label.
The draft rule also amended the Rule 19D sub rule (2) item (iii), related to the registration of medical devices by importers, adding a proviso and explanation to the effect that the importer can also submit an undertaking on or before November 30, 2021, that the company shall obtain the ISO 13485 certificate on or before May 31, 2022, in lieu of certificate of compliance.
A provisional registration number shall be generated which will remain valid up to May 31, 2022, or the date on which the applicant obtained such ISO certificate, whichever is earlier. The provisional registration number shall be valid for all purposes.
It has also declared that in case the ISO certificate is not obtained before May 31, 2022, as per undertaking, the provisional registration shall be deemed to be cancelled for all purposes without any notice. Here also, the relaxation has been extended to the mentioning of registration numbers on the label.
According to the ministry of health and family welfare’s notification on February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till end of September, 2021. From October 1, 2021, Class A & B Medical Devices will be under compulsory registration scheme up to September, 2022 and Class C&D medical devices will be under compulsory registration scheme up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.
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