DCGI Grants registration to Laboratory for testing Medical Devices, in vitro diagnostics on behalf of manufacturer

New Delhi: In a bold attempt to enhance in vitro diagnostics (IVDs) and medical device quality, safety, and performance, through the recent circular, the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO), the Drugs Controller General of India (DCGI) has notified all industry participants, including testing facilities and medical device/in vitro diagnostics manufacturing associations, that registration has been granted to laboratories with the goal of testing or evaluating medical devices on behalf of manufacturers.

This initiative, enacted under Chapter X of the Medical Device Rules (MDR) 2017, aims to bolster the country's testing facilities and ensure compliance with rigorous standards.

Additionally, the DCGI highlighted that medical device samples must meet the Bureau of Indian Standards (BIS) for performance and quality, and as a result, the devices must be tested in accordance with the specifications outlined in the BIS standards. Only additional standards listed in Rule 7 of the MDR may be used in the absence of a BIS standard.

The circular stated that with the implementation of the Medical Devices Rules, 2017 (MDR 2017) on January 1, 2018, the Drug Rules of 1945 no longer apply to medical devices and IVDs. Also, the product standards of medical devices as prescribed under Rule 7 of the Medical Device Rules (MDR) are mandatory as under:

“(1)The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 or as may be notiied by the Ministry of Health and Family Welfare in the Central Government, from time to time.

(2)Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO)or the International Electro-Technical Commission (IEC), or by any other pharmacopoeial standards.

(3)In case of the standards which have not been specified under sub-rule (1)and sub-rule (2), the device shall conform to the validated manufacturer's standards. ”

However, the DCGI noted that for medical devices that have BIS standards available, the testing of such devices is not being carried out as per BIS standards.

Taking into consideration the aforementioned, the circular declared ,

"It may be ensured that the samples of the medical devices shall comply to the BIS standards for its quality and performance and accordingly, the medical devices shall be tested with respect to the requirements as prescribed in the BIS standards. "

The circular further added,

"If no BIS standard is available, then only other standards as mentioned in Rule 7 of the MDR may be applied."

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To view the official notice, click the link below: