Medical Device: Centre to amend MDR 2017 to include ASTM

Rule 7 of the MDR -2017 provides product standards for medical devices.

Govt India
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Centre is planning to amend Medical Device Rules (MDR-2017) to include American Standard Test Method (ASTM) in product standards for medical devices to enhance competitiveness of indigenous medical devices globally.

Rule 7 of the MDR -2017 provides product standards for medical devices. Drugs Technical Advisory Board (DTAB) after detailed deliberation agreed to the proposal and recommended for necessary amendment in the MDR- 2017 in this regard.

Stakeholders and experts have been recommending an urgent need for the government to align the regulatory regime as per existing global standards to enable Indian medical device manufacturers to enhance their competitiveness and scale towards becoming export friendly.

It has been recommended that developed countries have their own certification requirements. Therefore, Indian medical device manufacturers will need to meet the requirements of countries where they export.

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As per rule 7 of MDR-2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards (BIS) established under Section 3 of BIS Act, 1985 (63 of 1985) or as may be notified by the Union health ministry, from time to time.

Where no relevant standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardization (ISO) or International Electro Technical Commission (IEC) or by any other pharmacopoeial standards.

In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards. Since the ASTM is accepted globally, it was proposed to include the ASTM in the sub-rule (2) of the rule 70 of MDR-2017.

DTAB was apprised that the union health ministry has notified the MDR- 2017 on January 31, 2017 under the provisions of the Drugs and Cosmetics (D&C) Act, 1940.

New MDR -2017 are effective from January 1, 2018 to regulate the clinical investigation, manufacture, import, sale and distribution of the medical devices in the country.

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