American Standard Test Methods Identified As New Standards For Medical Device Safety In India

 

India's Ministry of Health and Family Welfare has proposed a draft notification identifying American Standard Test Methods (ASTM) as one of the standard tools for demonstrating the conformance of medical devices to safe practices and forgetting the market access country.

This new notification would modify India Medical Device Rules 2017, especially the medical devices' product standards. It will increase the competitiveness of native medical devices internationally. As per the existing regulations in India, only ISO and I.E.C. international medical devices are recognized.

Recognition of the ASTM devices will provide manufacturers with an extra option for representing conformance as an essential part of their device registration with the Central Drugs Standard Control Organization (CDSCO). After this modification, the rules would be called Medical Devices (Amendment) Rules 2021. These rules will come into force on the date of their ultimate publication in the required official Gazette.

In the Medical Devices Rules 2017, in Rule 7, in sub-rule 2, after the letters and the bracket " the international Electro-Technical Commission ", the letters, words, bracket, or the " American Standard Test Method " will be inserted. Rule 7 offers information about product standards for medical devices. M.D.R. 2017 was issued in the Official Gazette through notification number G.S.R. 78 E, dated January 31.2017.

The draft amendment is proposed in exercise of the powers that have been conferred by subsection (1) of section (12) and sub-section (1) of section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940). After proper consultation with the Drugs Technical Advisory Board, it is published for informing all persons who are likely to be impacted.

The notice mentions that the given draft rules shall be considered on or after the expiry period of forty-five days starting from the date on which the copies of India's Gazette consisting of these draft rules were made available. These periods specified will be reflected by the Central Government. Objections and suggestions of any kind should be addressed to the Under Secretary (Drugs Regulation), Union Health Ministry, Government of India, Room number 434, C Wing, Nirman Bhavan, New Delhi -110011 or emailed at drugsdiv-mohfw@gov.in.

After proper deliberation, the Drugs Technical Advisory Board (DTAB) granted the proposal and recommended the required amendment in the M.D.R. 2017. All stakeholders and the experts have a recommendation for an urgent requirement for the government to align all regulatory regimes according to the current global standards to allow the Indian Medical Device manufacturers to increase competitiveness and measure towards being export friendly.

As all developed countries have their own certification needs; therefore, all Indian Medical Device Manufacturers must meet all the countries' recommendation where they are exporting.

According to rule 7 of MDR-2017, the medical device shall abide by the standards laid down by the BIS that was established under section 3 of BIS Act, 1985 or as may be notified by the Union Health Ministry in intervals. When no relevant standard of any medical device is laid down under the sub-rule, such instrument shall abide by the standard laid down by the International Organization of Standardization (ISO) or International Electrotechnical Commission (I.E.C.) or by any of the pharmacopoeial means.

In case of all standards that have not been specified under sub-rule one and sub-rule 2, the device shall conform to all reasonable manufacturers standards. As ASTM is accepted across the globe, it was then proposed to include it in the sub-rule 2 of Rule 70 of MDR-2017.