New Delhi: The Central drug regulator may look at amending the Medical Device Rules (MDR), 2017 to include the Quality Management System (QMS) requirements for Class A non-sterile and non-measuring medical device, in order to ensure quality of these products.
The Drugs Technical Advisory Board (DTAB) in a recent meeting, has agreed with a proposal to amend the relevant sections of the Rules, which would mean an amendment in the Chapter IIIB, which was incorporated into the Rules through a notification in October, 2022.
The Board, in its 91st meeting held in August, was apprised that the MDR under Chapter III B specify the provisions for exemption of license to manufacture & import of the Class A (non-sterile and non-measuring) medical devices for marketing in the country.
While the Rule exempted licensing, the manufacturer or importer may obtain registration number by submitting the requisite information prescribed under sub-rule (2) of Rule 19H and sub-rule (2) of 19J of MDR, 2017, respectively.
It observed that the scope for conformance of QMS for manufacturing of such medical devices is not included in the rules. QMS is utmost important for manufacturing of medical devices to ensure that the product meets relevant standards and essential principles applicable for medical devices and the firm shall adhere with the QMS of fifth schedule of MDR, 2017, so that the safety and performance of medical devices will be ensured.
Hence, the undertaking stating that the manufacturing facility has complied the QMS as prescribed in the Fifth Schedule of MDR, 2017 may be included in the said rules, noted the Board.
“Accordingly, it was proposed that to amend rule 19H and 19J of Chapter IIIB of Medical Device Rules, 2017 to include the Quality Management System requirements for Class A (non-sterile and non-measuring) medical device,” said the DTAB.
The Board deliberated the matter and agreed for the proposed amendment under MDR, 2017, it said.
It may be noted that the Centre has notified the amendment of MDR, 2017, to exempt Class A (non-sterile and non-measuring) medical devices from import license and include the Chapter IIIB regarding the registration of these class of medical devices, in October, 2022. The Section 19H deals with information for registration to be uploaded by the industry, while 19J deals with the import of these class A medical devices.
The non-sterile and non-measuring medical devices include items such as gauze, instruments, scalpels, scissors, knives, etc.
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