The Ministry of Health and Family Welfare vide notification dated 5th February, 2021 has issued Medical Devices (Amendment) Rules, 2021. The Amendment provides that when no relevant Standard is laid down by Bureau of Indian Standards for any medical device, such device shall conform to the standard laid down by the International Organization for Standardization (ISO), the International Electro Technical Commission (IEC), American Standard Test Method (ASTM) or any other pharmacopoeia standards. Previously the standards laid down by American Standard Test Method (ASTM) was not recognized.
Objections and suggestions, if any, may be emailed at drugsdiv-mohfw@gov.in within forty five days.
