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Law Updates

Notified Draft Amendment Rules For The Registration Of Class A Medical Devices (CDSCO New Rules)

Department: CDSCO

Authority: Medical Device

2022-09-21

The Ministry of Health and Family Welfare on Tuesday notified draft amendment rules for the registration of Class A medical devices through an identified online portal established for the purpose.

All the A and B-class manufacturers are required to transition to the licensing regime by 1st October. This notification came as a big relief to the manufacturers who are still awaiting audits from the government licensing authorities.

The Key highlights of the draft amendment rules for Manufacturer

  • The manufacturer has to only submit an undertaking stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring)
  • The manufacturer shall self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices.
  • The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.