Download notifications. Links are given below: The Union health ministry has notified the Regional Drug Testing Laboratory (RDTL) in Chandigarh as one of the Central Medical Devices Testing Laboratories to test various medical devices, as part of expanding the testing capacity to ensure the quality of medical devices in the country.

Download Notification No. S.O. 4573(E) dt 28-09-2022 Notification for designation of RDTL Chandigarh also as CMDTL as per MDR 2017

Download Notification No. S.O. 4574(E) dt 28-09-2022 Designation of Government Analysts at RDTL Chandigarh as MDTO as per MDR 2017

Regional Drugs Testing Laboratory, Chandigarh

The Ministry, through a notification issued on September 28, added the regional laboratory as part of the list of labs it had earlier announced as central testing laboratories for the following categories:

- Disposable hypodermic syringes,
- Disposable hypodermic needles,
- Disposable perfusion sets,
- Catheters,
- I V Cannulae,

- Scalp Vein Set,
- Ligatures,
- Sutures,
- Staplers,
- Surgical Dressing
- Umbilical Tapes.

Click for more on RDTL

The notification comes in addition to an earlier notification by the Ministry on June 1, 2018, which designated five laboratories having facilities for carrying out tests and evaluations of medical devices as Central Medical Device Testing Laboratories.

The central laboratory has been designated for the purpose of testing and evaluation, functioning as an appellate laboratory, and carrying out any other function as may be specifically assigned to it by the central government.

National Institute of Biologicals, Noida

Under the notification, the National Institute of Biologicals, Noida was designated to test in vitro diagnostics for:

- Human immunodeficiency virus,
- Hepatitis B,
- Surface antigen,
- Hepatitis C virus,
- Blood grouping Sera,
- Glucose test strip,
- Fully automated analyzer-based glucose reagent.

Central Drugs Testing Laboratory, Chennai

The Central Drugs Testing Laboratory in Chennai was designated to test condoms.

Central Drugs Testing Laboratory, Kolkata

The Central Drugs Laboratory, in Kolkata, was designated to test:

- Surgical dressings,
- Surgical cotton,
- Surgical bandages,
- Disinfectants.

Regional Drugs Testing Laboratory, Guwahati

The Regional Drugs Testing Laboratory, Guwahati, was designated to test:

- Disposable hypodermic syringes,
- Disposable hypodermic needles,
- Disposable perfusion sets,
- IV cannulae.

Central Drug Testing Laboratory, Mumbai

The Central Drug Testing Laboratory, Mumbai has been assigned to testing Intrauterine Devices (IUD) and Falope Rings.

To this list of five laboratories, the RDTL, Chandigarh, is being added as the sixth such Central Medical Devices Testing Laboratory, now.

It may be noted that a Parliamentary Panel has recently observed that the country has only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO, which is grossly insufficient keeping in view the size of the country.

It was opined that having adequate common infrastructure, including accredited laboratories in different regions of the country for standard testing, would significantly encourage local manufacturers to get their products tested for standards, and such measures would also help in reducing the cost of production, which ultimately will improve the availability and affordability of medical devices in the domestic market.

The Parliamentary Panel, which has looked into medical device regulation in the country, recommended the Ministry introduce standards and certification processes, particularly for Class C and D products, comparable to global standards.

It also recommended the Ministry extend financial support to the local manufacturers in capacity building for compliance with US and European Union regulations till the domestic industry catches up with the comparable standards and certification process.

The Department-Related Parliamentary Standing Committee (DRPSC) on Health and Family Welfare, in its 138th report on ‘Medical Devices: Regulation & Control’, observed that the Indian Medical Devices Industry presently lacks a research ecosystem and infrastructure for manufacturing high-tech, advanced medical devices (Class C&D) and the Indian Medical Devices Industry doesn’t have facilities to produce such medical devices comparable to global standards.

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