To ensure quality, safety, performance of Medical Devices(MD)/ In-vitro diagnostics (IVD), the Ministry of Health and Family Welfare, Government of India has granted registration of Laboratory for carrying out Test or Evaluation of Medical Device on behalf of a manufacturer, under Chapter X of Medical Device Rules 2017 to strengthen testing facility. Drug Rules, 1945 are no longer applicable to MDs/IVDs.
To ensure quality, safety, performance of Medical Devices(MD)/ In-vitro diagnostics (IVD), the Ministry of Health and Family Welfare, Government of India has granted registration of Laboratory for carrying out Test or Evaluation of Medical Device on behalf of a manufacturer, under Chapter X of Medical Device Rules 2017 to strengthen testing facility. Drug Rules, 1945 are no longer applicable to MDs/IVDs.
- The medical device has to conform to standards of Bureau of Indian Standards established under section 3 of Bureau of Indian Standards Act.
- Where no relevant standard of any medical device has been laid down under sub rule, it will follow International organization for standardization (ISO) or International Electro Technical Committee (IEC) or other pharmacopeial standards.
- In case of standards not specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturers standards. Product standards of Medical Device Rules are mandatory.