The Union Health Ministry has issued a draft notification proposing various amendments to the Medical Devices Rules, 2017. The draft seeks to allow registration certificates and manufacturing licences for certain classes of medical devices to remain valid in perpetuity, subject to conditions including payment of a retention fee under the provisions of the Medical Devices Rules, 2017.
The amendments include inserting a new form, MD‑44, to standardise the format for reports of test or evaluation conducted by registered medical devices testing laboratories to declare device quality.
Under the proposed changes, the draft notification also amends Form MD‑2 for certificates of registration for notified bodies under the Medical Devices Rules, and Form MD‑40 for registration of medical devices testing laboratories, to reflect that the registration certificates will remain valid indefinitely unless suspended, cancelled or surrendered, provided the retention fee is deposited as required.
The draft further proposes similar amendments for Form MD‑5, which covers licences to manufacture for sale or distribution of Class A (other than non‑sterile and non‑measuring) and Class B medical devices, and Form MD‑6 for loan licences for these devices. These licences, like registration certificates, would remain valid in perpetuity subject to retention fee conditions.
Amendments are also proposed for Form MD‑9 and Form MD‑10, which pertain to licences to manufacture and loan licences for Class C and Class D devices for sale or distribution, to provide the same perpetual validity framework tied to retention fee deposits. The draft proposes the addition of the words “registration number in case of Class A (Non‑Sterile and Non‑Measuring) Medical Devices” to various rules to facilitate device registration under the applicable regulations.
Changes are also proposed to the Second Schedule to revise the fee structure, replacing the provision for fees for “one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device” with fees for “one overseas site manufacturing Class C or Class D in vitro diagnostic medical device.”
Additionally, the applicability clause of the Fifth Schedule of the Medical Devices Rules, concerning the quality management system, would be amended to state that the provisions of the schedule apply to manufacturers of medical devices including in‑vitro diagnostic medical devices.
The draft notification also proposes adding provisions for details of samples of medical devices and related procedures under various forms, including receipt for stock of medical devices seized under specified clauses of the Drugs and Cosmetics Act and requirements for intimating the person from whom the sample is taken.
The Ministry’s revisions to the Medical Devices Rules, 2017 are part of ongoing efforts to include additions and simplify procedures in the regulation of the medical devices sector following the integration of medical devices under the purview of drug regulators.
