Medical Devices Rules, 2016 (DRAFT) released by Health Ministry, India

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The Union health ministry has issued the revised draft Medical Devices Rules 2016, introducing the ‘Quality Management System’ mandatory for notified medical devices and in-vitro diagnostics in lieu of the Schedule M which will now be applicable to pharmaceuticals products only.  

As per the new Rule, the licensee of pharmaceutical products shall comply with the requirements of ‘Good Manufacturing Practices’ (GMP) as laid down in Schedule M and the licensee of medical devices and in-vitro diagnostics shall comply with the requirements of  “Quality Management System” as laid down in Schedule M-III.

The provisions of this Schedule M-III shall be applicable to manufacturers of finished devices, in-vitro diagnostics, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use.

The Schedule M-III specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labeling, testing, installation and servicing of medical devices and in-vitro diagnostics. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.  

If any requirement in clause 7 (product realisation) of this Schedule is not applicable due to the nature of the medical device and in-vitro diagnostics for which the quality management system is applied, the manufacturer does not need to include such a requirement in its quality management system.  The processes required by this Schedule, which are applicable to the medical device and in-vitro  diagnostic devices, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer’s quality management system.

If a manufacturer engages in only some operations subject to the requirements of this part, and not in others, that manufacturer need only to comply with those requirements which are applicable to the operations in which it is engaged.  It is emphasised that the quality management system requirements specified in this Schedule are in addition to complementary to technical requirements for products. Manufacturers of components or parts of finished devices and in-vitro diagnostics are encouraged to use appropriate provisions of this regulation as guidance.

Source: 1

The Official release of the DRAFT – Medical Device Rules can be found at LINK

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