The Union health ministry will soon amend Schedule M III relating to requirements of factory premises for manufacture of medical devices and in-vitro diagnostic reagents or kits to bring all the notified medical devices under the ambit of Schedule M III which at present is being regulated under the provision of the Drugs and Cosmetics Rules, 1945.

Schedule M III provides requirements of factory premises for manufacture of medical devices under the Drugs and Cosmetics Rules, 1945. The present rule introduced in 1994 relates only to three medical devices namely sterile perfusion and blood collection sets, sterile hypodermic syringes and needles, while large number of devices has since been notified and is being regulated under the provision of the Drugs and Cosmetics Rules, 1945.

The proposal to introduce a revised Schedule M III relating to the quality of medical devices and in-vitro diagnostics reagents or kits was considered in the 68th meeting of the DTAB held on April 16, 2015 and a sub-committee, under the chairmanship of Dr. B Suresh, president, Pharmacy Council of India, was constituted for comprehensive review of Schedule M III.

The matter was considered by the sub-committee in its meeting held on June 12, 2015 and committee considered the various suggestions received from the stakeholders and finalised the Schedule M III on the quality management system for notified medical devices and in vitro diagnostics.

The DTAB, in its 70th meeting held on August 18, 2015, accepted the recommendations of the sub-committee and recommended that the Schedule M III may be incorporated under the Drugs and Cosmetics Rules, 1945 and relevant rules amended for the application of the Schedule exclusively for medical devices. The Schedule M should be applicable in the case of drugs only.

The provisions of the revised Schedule M III will 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, intended for human or animal use that is manufactured in India.

This revised 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 and shall exclude the provisions of relevant clauses of this schedule. The manufacturer shall ensure the claims of conformity with this schedule to reflect the exclusions.