Last Updated on October 6, 2024 by The Health Master
Download the updated list of Medical Devices Testing Laboratories, the link is given below: 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.
- 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,
- 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.
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