The Union Health Ministry has published a draft notification vide no. GSR 98 E dt 5.2.2021 on Medical Devices Amendment rules 2021 to involve American Standard Test Method (ASTM) in standards of product for all medical devices to increase the competency of indigenous medical devices internationally.
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According to the draft rule, all these rules might be called the Medical Devices (Amendment) Rules 2021. All these rules will come into force on the date when they are finally published in the official gazette. In the medical device rules 2017, in rule 7, in sub-rule 2, after the words, letters, and bracket" the international electro technical commission," the words, letter, and bracket or "American standard test method" will be inserted.
The following draft of specific rules for amending MDR 2017 is done while exercising the powers given by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act,1940. In consultation with the Drugs technical advisory board, it was published to inform every person who is likely to be impacted. Notice is given to all that the said draft rule will be considered on or after 45 days from the date on which the Gazette of Indiaconsisting of these draft rules is published.
The central government considers the timeframe specified above. All kinds of objections and suggestions should be addressed to the undersecretary, union health ministry, Government of India. Drugs Technical Advisory Board, after complete deliberation, approved the proposal and suggested these required amendments in the MDR-2017.
It has been suggested since all developed countries possess their own certification needs. So, Indian Medical device manufacturers will be required to meet the needs of countries where they export. According to rule 7 of MDR 2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of BIS Act, 1985 or might be notified by the Union health Ministry frequently.
If the standards have not been specified under sub-rule one and sub-rule 2, the device shall be confirmed to the validated manufacturer's standards. This is as per the medical device regulation in India. Because ASTM is accepted at the international level, it was proposed to include ASTM in the sub-rule 2 of rule 70 of MDR 2017.
DTAB was apprised that the Union health ministry notified the MDR 2017 on January 31, 2017, under the provision of the Drugs and Cosmetics Act, 1940.
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