Revised List Of Medical Devices Testing Laboratory (MDTL) Under MDR 2017

With an objective to efficiently regulate the medical devices under the Drugs and Cosmetics (D&C) Act in a phase-wise manner, CDSCO or the central Drugs Control Organization has advised four medical device testing laboratories to carry out the evaluation of the medical devices.

Central Government entitles different labs as Central Medical Device Testing Laboratory under MDR 2017. These laboratories offer a boost to the domestic manufacturing sector by providing the required infrastructure for testing the device depending on the project proposals and the technical support provided by the National Health Systems Resource Centre, which is a technical support organization governed by the health ministry.

By perusing the powers offered by sub-rule 2 of rule 19 of the Medical Device Rules 2017, has entitled some laboratories with facilities for doing test and evaluation of the medical devices. Its sole purpose is

●       Testing and evaluation

●       Functions as an appellate laboratory

●       Carry out function about medical devices that are specially assigned by Central Government 

The new rules were notified in the year 2017 on January 31 as per the D&C act to regulate the manufacture, sale, import, and distribution of all medical devices, which came into effect from January 1.2018.

As per the rule, Sipra labs in Telangana, Hyderabad, are responsible for carrying out the test and evaluating some medical devices like Copper –T, Sterile Hypodermic Needles Hypodermic Syringes, Blood Bags, condoms, etc.

Star Imaging and Path Lab of West Delhi will evaluate Bilirubin test, Reagents/ kits, Creatinine test reagent, Aspartate Aminotransferase, Alanine Aminotransferase, Uric Acid test reagents, total protein test reagents, along with Prothrombin time test reagents kits.

Alcatel Research Laboratories India Pvt Ltd, based in Haryana, will make an evaluation of Sterilized surgical ligatures, sterilized disposable devices, along sterilized surgical sutures.

Sree Chitra Tirunal Institute of medical science and technology, Thiruvananthapuram, will make an evaluation of the cardiovascular devices, Neuroprosthesis, and orthopedic implants.

The union health ministry is making plans to improve the workforce at CDSCO for efficient licensing and execution activities to ensure safety, best quality, and devices' overall performances.

Because when so many medical devices are under regulatory control, it will lead to enhancement of workload. Therefore, a total of 754 CDSCO officers and staff will be added to the already existing workforce, which has 119 regulatory and lab staff, before implementing the second phase.

The regulatory infrastructure, along with the manpower, must be strengthened for licensing and enforcement activities, according to the Drugs Technical Advisory Board report. It was also recommended by DTAB that all those five laboratories must get ready within a period of 5 years for testing several medical devices along with in-vitro diagnostics medical devices.

Go to know more information: Medical Device Regulation India | Drug product registration in India