Govt notifies RDTL Chandigarh as Central Medical Devices Testing Laboratory

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

627
Govt of India
Govt of India

Last Updated on January 6, 2024 by The Health Master

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.


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.

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.

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain license for Commercial Testing Laboratories

Latest Notifications: Testing Laboratories

NABL 164 released : Guidelines for Inter-laboratory comparison

NABL: List of NABL Accredited Testing Laboratories

Procedure to obtain license for manufacturing of Medical Devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017    

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Bags and its Testing

Medical Device Alert: Lists

NABL 126: Specific criteria for calibration of Medical Devices

FDA to Doctors, Hospitals: Report adverse drug reactions

USFDA approves Mirabegron extended-release tablets

State FDAs of these states to be strengthened soon

Drug recall: Acyclovir Sodium Injection recalled due to this reason

FDA J&K suspended licenses of Medicals Stores & Pharma Dealers

J & J appeals to Maharashtra FDA minister to revoke cancellation of license

Changing the Regulations for Class A Medical Devices and its Impact

Govt plan to ban Codeine based cough syrups opposed by Pharma companies

Pharmacists – The Doctors behind the screens

Latest Notifications regarding Pharmaceuticals

For informative videos on Medical Devices, click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news