The Ministry of Health and Family Welfare (“Ministry”) has, in a Notification dated 11^th February, 2020, issued the Medical Devices (Amendment) Rules, 2020 (“Amendment Rules”), to amend the Medical Devices Rules, 2017 (“Principal Rules”), effective 1^st April, 2020.

The Amendment Rules propose to insert a new Chapter IIIA, relating to registration of medical devices, under the Principal Rules.

Key Highlights:

1. Registration will be required for devices notified under *Section 3(b) of the Drugs and Cosmetics Act, 1940.

All medical devices and devices specified in the new Annexure to the Eighth Schedule of the Principal Rules, inserted by the Amendment Rules, will be exempted from the requirement of getting registration. Amendment Rules have also inserted a new serial no. 7 in the Eighth Schedule to the Principal Rules to give effect to such exemption.

1. The medical devices will be required to be registered with the Central Licensing Authority (“Authority”) through the online portal established by the Central Drugs Standard Control Organisation (“CDSCO”) for this purpose

1. Registration of the medical devices will be on voluntary basis till 1^st October, 2021 i.e. for a period of eighteen months from the commencement of the new chapter inserted by the Amendment Rules.

Subsequent the registration of medical devices will become mandatory.

1. Registration of medical device has to be obtained by the following:

1. Manufacturer of medical device
2. Importer of medical device

The Amendment Rules also prescribes the information to be uploaded by the manufacturer or the importer of medical device, on the “Online System for Medical Devices” (“Online System”) established by CDSCO, for the registration of the medical devices.

1. After the required information are uploaded on the Online System, for the registration of medical devices, a registration number will be generated for the applicant.

The manufacturer or the importer of the medical devices will be required to mention the registration number on the label of the medical device.

1. The Amendment Rules will also empower the Authority to verify the documents relating to the medical devices at any point of time and investigate any quality or safety related failure or complaints. The Authority will also have the power to cancel or suspend for such period of time as it deems fit the registration number of the registrant, either wholly or in respect of any of the medical devices to which it relates, if it is of the opinion that the registrant has failed to comply with any provision of the Principal Rules.

Source: Ministry of Health and Family Welfare

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