In a bid to regulate all medical devices under Drugs and Cosmetics (D&C) Act in an effective way, the Central Drugs Standard Control Organisation (CDSCO) has notified ten more medical devices testing laboratories (MDTL) for carrying out evaluation of medical devices under the new Medical Devices (MD) Rules 2017 on behalf of manufacturers in the country.

With this, the total number of MDTLs notified for conducting evaluation of medical devices reached 14.

The new MD rules were notified on January 31, 2017 under D&C Act to regulate manufacture, import, sale and distribution of medical devices which were effective from January 1, 2018.

The recently notified MDTLs are Tamil Nadu based GLR Laboratories & Trustin Analytical Solutions, Telangana based Palamur Biosciences, Bangaluru based Eurofins Advinus, West Delhi based Devansh Testing & Research Laboratory, ITL Labs, Conformity Testing Labs, Rajasthan based Jagdamba Laboratories & Brothers Laboratories and Gujarat based Accuprec Research Labs.

As per Rule 81 of MD Rules, 2017, GLR Laboratories will conduct biological evaluation of cardiovascular devices, orthopaedic devices, ocular devices, surgical devices & sutures, respiratory devices, gastrointestinal devices, urological devices, haematological devices & IV sets, dental devices, personal care products & family planning, neurological devices, all medical devices & materials as per ISO 10993.

Palamur Biosciences will evaluate biological toxicity of catheters, disposable hypodermic needles, surgical dressings, orthopaedic implants, blood bags, drug eluting stent, intraocular lenses, sutures, condoms, heart valves, disposable perfusion sets, cardiac stent, copper-T, scalp vein set.

Eurofins Advinus will evaluate disposable perfusion sets, cardiac stents, drug eluting stents, blood bags, catheters (class- B,C, D), heart valves, intraocular lenses, IV cannula, bone cements, internal prosthetic replacements, peritoneal dialysis sets, condoms, intrauterine devices, surgical dressing, scalp vein set, ligatures & sutures.