Industry

Govt notifies MDR amendment for State Medical Devices Testing Laboratories

Download notification No. GSR No. 409(E) dt 02-06-2023,

The Health Master

June 9, 2023

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Last Updated on January 19, 2024 by The Health Master

Medical Devices Testing Laboratories

Download notification No. GSR No. 409(E) dt 02-06-2023, the link is given below: The Ministry of Health and Family Welfare (MoHFW) has recently issued a final notification that brings amendments to the Medical Devices Rules (MDR), 2017 vide notification No. GSR No. 409(E) dt 02-06-2023.

Download notification No. GSR No. 409(E) dt 02-06-2023.

The primary purpose of these amendments is to define the State Medical Devices Testing Laboratory and enable the establishment of such laboratories by the State governments.

This move aims to bolster the presence of testing facilities for medical devices across the country, aligning with the regulatory changes in the sector, including the introduction of a licensing regime.

Defining State Medical Devices Testing Laboratories:

In March of this year, the Ministry released a draft rule proposing the inclusion of a new sub-rule to Rule 19.

According to this amendment, State governments have the authority to establish State Medical Devices Testing Laboratories, primarily for testing and evaluating medical devices.

Additionally, these laboratories may undertake other assigned functions. Furthermore, the State government can designate any laboratory equipped with medical device testing and evaluation capabilities as a State Medical Devices Testing Laboratory, provided it is accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

Expanding the Scope of Rule 19:

The amendment introduces a definition for the term “State Medical Devices Testing Laboratory.” This definition clarifies that it refers to a laboratory established or designated by the State Government under Rule 19(3), which is the newly proposed sub-rule.

Notably, Rule 19, originally focused on the Central Medical Devices Testing Laboratory, is now open to amendment to emphasize that laboratories can be established by both the Central and State governments.

Public Consultation and Feedback:

Upon issuing the draft notification, the Ministry invited objections and suggestions from stakeholders within a specified period.

In the final notification, the Ministry stated that it had duly considered the objections and suggestions received from the public regarding the draft rules.

Importance of Testing Laboratories:

Industry experts stress the importance of having accessible medical devices testing laboratories in locations where medical device facilities are present.

These laboratories are crucial for expediting testing operations, especially considering that a licensing regime has been in place for a section of medical devices since 2022, and another section is scheduled to be included in October of this year.

Strengthening the Testing Network:

To enhance the medical devices testing laboratories (MDTLs) network in the country, the Central Drugs Standard Control Organisation (CDSCO), the regulatory body overseeing drugs, medical devices, and cosmetics, has been urging laboratories with adequate quality accreditation to submit applications for testing medical devices.

As of November 2022, around 28 laboratories had been registered with the CDSCO for testing purposes.

Background on Medical Device Regulation:

Prior to 2017, the Medical Device Sector in India remained largely unregulated.

However, the introduction of the Medical Device Rules, 2017 by the MoHFW marked a comprehensive regulatory framework for medical devices, focusing on aspects such as quality, safety, and efficacy, under the Drugs and Cosmetic Act, 1940.

Projected Growth of the Medical Device Sector:

The medical device sector in India is expected to witness substantial growth, with market size projected to increase from the current US$ 11 billion to US$ 50 billion by 2025.

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