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Is any certification from Bureau of Indian Standards required for all Class A devices also?
As per Rule 7(1) of the Medical Devices Rules, 2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards (BIS) or as may be notified by the Ministry of Health and Family Welfare. However, for Class A medical devices, if no relevant BIS standard is available, the device shall conform to the standards laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.