The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –

“In the Medical Devices Rules, 2017, in rule 7, in sub-rule (2), after the words, letters and bracket “the

International Electro Technical Commission (IEC)” the words, letters and bracket “or American Standard Test Method (ASTM)” shall be inserted.”

It means that, the CDSCO will be accepting the American Standard Test Methods (ASTM) standards, while evaluating the device registration application. As per the original medical devices rules, 2017, the medical devices intended to be marketed in India shall comply with the standards released by Bureau of Indian Standards, established by Bureau of Indian Standards Act, 1985 or by the Ministry of Health (MoH), India. In case there are no relevant BIS standards in effect, the medical devices shall comply with relevant International Standards Organization (ISO) or International Electro Technical Commission (IEC) standards. In case of no standards (ISO/IEC/BIS) available, the devices shall comply with Pharmacopoeial standards. In case of non-availability of either Global standards or Pharmacopoeial references, the devices shall comply with the standards defined and validated by the device manufacturer.

The draft rules are open for comments and feedback for forty-five (45) days, after which the rules will be in effect. The industry stakeholders can email their objections and suggestions to drugsdiv-mohfw@gov.in or send postal mail addressed to Secretary (Drugs Regulation), Union Health Ministry, Government of India, Room Number 434, C Wing, Nirman Bhavan, New Delhi – 110011.

What it means to the medical device industry?

The US based manufacturers, who have their medical device tested for conformance with ASTM standards can now enter the Indian market without the need for additional testing to validate their compliance with ISO / IEC standards. The Indian medical device manufacturers have to design, develop and manufacture the medical devices in alignment with the global Regulatory standards and hence can export to the foreign markets. The new amendment to incorporate additional standards would help the local manufacturer to plan for global market access and to tap potential markets.

Therefore, to enhance the scale of global market access, the medical device manufacturers are advised to comply with the CDSCO new amendments. To avoid Regulatory recalls and achieve a seamless registration process, seek an expert’s advice. Stay informed. Stay compliant.