DCGI emphasises need for sample test for standards for medical devices and IVDs

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

The DCGI has issued a circular to all stakeholders in the sector, including all medical devices testing laboratories and manufacturing associations, elaborating the requirement for testing.

“…it may be ensured that the samples of the medical devices shall comply with 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,” said the regulator.

“If no BIS standard is available, then only other standards as mentioned in Rule 7 of the MDR (Medical Devices Rules) may be applied,” he added.

In order to ensure the quality, safety and performance of medical devices and IVDs, the Union ministry of health and family welfare has granted registration of laboratory for carrying out test or evaluation of medical devices on behalf of a manufacturer, under Chapter X of MDR, 2017 to strengthen the testing facility in the country.

Consequent to the implementation of MDR, 2017 with effect from January 1, 2018, the Drug Rules, 1945 are no longer applicable for medical devices and IVDs.

According to the Rule 7 of the MDR, the medical device shall conform to the standards laid down by the BIS established under Section 3 of the Bureau of Indian Standards Act, 1985 or as may be notified by the ministry of health and family welfare in the Central government, from time to time.

A second sub-rule adds that where no relevant standard of any medical devices has been laid down under the sub rule (1) regarding the BIS standards, such devices shall conform to the standard laid down by the International Organisation for Standardisation (ISO) of the International ElectroTechnical Commission (IEC), or by any other pharmacopoeial standards.

In case of the standards which have not been specified in these two sub-rules, the device shall conform to the validated manufacturer’s standards.

“It has been observed that the medical devices which have BIS standards available, the testing of such devices are not being carried out as per BIS standards,” said the drug regulator.

It may be noted that the central drug regulator has repeatedly requested private medical devices testing facilities in the past to come out and register themselves as Medical Devices Testing Laboratories (MDTL) on behalf of the manufacturers, in an effort to strengthen the MDTL network in tandem with the growing requirement for quality tests.

The Central Drugs Standard Control Organisation (CDSCO) is responsible for ensuring the quality, safety and performance of medical devices under the Medical Device Rules, 2017. With the implementation of two notifications on February 11, 2020, all medical devices have come under the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017.

With more devices falling under the ambit of drugs, the requirement for more testing facilities for these medical devices has emerged, and the regulator has been in an effort to gather the infrastructure to test the products, both manufactured and imported to the country, on time without the industry meeting delays to reach the market.

So far, certain private testing labs have been registered under MDR, 2017 for testing and examination of certain medical devices in the country on behalf of the manufacturer, says the regulator.

In order to strengthen the private testing facility for medical devices in the country, the CDSCO is in the process of identifying the existing private labs having the facility to test the medical devices, so that these labs may be registered under MDR, 2017, said the DCGI in one such request earlier this year. The medical devices require various tests including physical, chemical, microbiology, mechanical and electrical, etc.

“… it is requested that you may kindly identify your facility for testing of the above tests for medical devices and submit the application in Form MD-39 along with the requisite information with fees as per MDR, 2017 for registration of testing laboratory on behalf of the manufacturer,” added the DCGI in a communication to all stakeholders.

According to CDSCO, till September, 2023, it has approved a total of 39 laboratories across the country to to carry out test or evaluation of a medical device on behalf of the manufacturer applied under Form MD-40, under the MDR, 2017. This include nine MDTLs applied during the year 2023, including the laboratory of public sector undertaking HLL Lifecare Ltd and Atal Incubation Centre (AIC), Medivalley at Andhra Pradesh MedTech Zone (AMTZ).

In December, 2022 also, the DCGI has requested the laboratories which have capacity for testing medical devices, with adequate quality accreditation to submit applications to strengthen the medical devices testing laboratories (MDTLs) network in the country.

The medical device sector has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by the MoHFW for comprehensive regulation of medical devices in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940. The government has later classified the devices into four classes and brought them under licensing regime in a phased manner, bringing all the devices under the licensing regime by 2023.

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