CDSCO approves two more medical devices testing laboratories

New Delhi, March 13, 2023 :

The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017. With this, the total number of MDTLs approved by the regulator is 30 across the country.

The newly added laboratories are Bharat Test House Pvt Ltd situated in North West Delhi and Manisha Analytical Laboratories Pvt Ltd in Mumbai.

Bharat Test House has approval to conduct tests on 20 devices including surgical luminaries and luminaries for diagnosis, operating tables, ultrasonic physiotherapy equipment, baby incubators, and medical electrical equipment in various classes under the MDR, 2017.

Manisha Analytical Laboratories has approval to test 13 medical devices including sterile blood bags, sterile catheters, disposable hypodermic needles, disposable perfusion set, IV cannula, orthopaedic implants, contraceptive devices, intraocular lens, surgical dressings, cardiac stents and drug eluting stents, heart valve, surgical sutures and ligatures among others.

According to the list released by the CDSCO, these laboratories were approved during the year of 2022. With this, a total of 11 laboratories were approved by the CDSCO during the year of 2022, while in the previous year the regulator approved eight laboratories.

In November, 2021, the CDSCO updated its list of approved MDLTs with four new laboratories, taking the total number of MDTLs with approval to 28.

It may be noted that the ministry of health and family welfare (MoHFW) has recently took forward its plan to rope in state governments also to establish, or designate their existing laboratories, as state MDTLs and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.

The Union health ministry is looking at bringing in the support of state governments to actively participate in the testing activities, in order to ensure the quality of medical devices. It is amending the Medical Devices Rules, 2017, with introduction of Sub-Rules and changes in the existing ones relevant to bring in the desired regulatory framework.

A Draft Rule was recently notified by the Ministry, under which it has proposed to insert a new Sub-Rule to the Rule 19, that the State government may, by notification, establish State MDLTs for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.

The state government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state MDLTs for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

It has also added a definition to the State Medical Devices Testing Laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central MDLTs, the Draft Rule proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the State Government.

Industry experts have been raising concerns about the availability of proper medical devices testing laboratories for faster testing operations, considering that the licensing regime for a majority of the medical devices is expected to be in place soon.

CDSCO had earlier also requested the laboratories which have capacity for testing medical devices, with adequate quality accreditation to submit applications to strengthen the 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. Pharmabiz