Testing and Evaluation of Medical Devices and IVDs
To ensure the quality, safety, and performance of Medical Devices (MDs) and In Vitro Diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India, has registered laboratories to conduct tests and evaluations on behalf of manufacturers. This registration is under Chapter X of the Medical Device Rules 2017, aimed at strengthening the country’s testing facilities.
It is important to note that with the implementation of the Medical Device Rules (MDR) 2017, effective from January 1, 2018, the Drug Rules 1945 no longer apply to MDs and IVDs.
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The standards for medical devices, as mandated under Rule 7 of the MDR, must be adhered to as follows:
- Medical devices must conform to the standards set by the Bureau of Indian Standards (BIS) under the Bureau of Indian Standards Act, 1985, or as notified by the Ministry of Health and Family Welfare.
- If no BIS standard exists for a medical device, it should comply with standards set by the International Organisation for Standardisation (ISO), the International Electro-Technica Commission (IEC), or other recognized standards.
- If no standards are specified under the above sub-rules, the device must conform to validated manufacturer standards.
It has been observed that some medical devices with available BIS standards are not being tested according to these standards. Therefore, it is essential that all medical device samples comply with BIS standards for quality and performance. Testing should be conducted according to BIS standards wherever available. If no BIS standard exists, the other standards mentioned in Rule 7 of the MDR should be applied.
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