Centre notifies new medical device rules

The Medical Devices (Amendment) Rules, 2022 were notified by the Union Cabinet recently.

Key facts

  • The new rules require online registration of all manufacturers of all class A medical devices.
  • Class A medical devices are those having low-to-moderate risk to patient or user. These include surgical dressings and others.
  • All class A and B manufactures are required to transition to new licensing regime by October 1.
  • Under the new regime, it is mandatory for the manufacturer to give an undertaking that affirms that the proposed device is Class A medical device – non-sterile and/or non-measuring.
  • The manufacturer is required to self-certify that the medical device complies the essential principles checklist for safety and performance as well as the Medical Devices Rules, 2017.
  • This information must be provided in the Online System for Medical Devices for receiving the registration number of the medical devices.
  • Under the new rules, the importer of medical devices is required to upload his name and address and the manufacturing site, as well as the details about the medical devices. The self-attested copy of the registration of foreign manufacturing site issued by the competent authority must also be included.
  • The new rules mandate record maintenance by the manufacturer or the importer about manufacturing, import, sales and distribution.
  • These records must be disclosed if any licensing authority requires it.
  • Licensing authorities can access these records at any point of time to investigate the quality of these devices and assess the safety-related failures or complaints.
  • The registration number may be cancelled or suspended if the manufacture or importer do not comply with the new medical devices rules.

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