Revised List Of Medical Devices Testing Laboratory (MDTL) Under MDR 2017
by Dolly K. Digital Marketing ExecutiveWith 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
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Created on Apr 30th 2021 09:14. Viewed 220 times.