Mumbai : 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.
Trustin Analytical Solutions will evaluate disinfectant (sterility & antimicrobial activities of disinfectant as per ISO 11737-1&2, USP 42, EP 9.0, IP 2018, BP 2018), catherters (sterility, bioburden and BET of catherters as per ISO 11737-1&2, USP 42, EP 9.0, IP 2018, BP 2018)- Class A, B, C, D, surgical sutures (physical parameters, sterility & BET as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)- Class A, B, C, surgical dressings (sterility, bioburden, BET as per IS 758, IS 1954, ISO 11737-1&2, IP 2018, USP 42, BP 2018 & EN 9.0)- Class A, B,C & D, blood bags with and without anticoagulant solutions (mechanical, sterility & BET as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018), contraceptives (condoms- male/female condoms) (mechanical parameters, bioburden & pathogens as per ISO 4074-2015, WHO UNAIDS 2010, ISO 25841-2017, WHO UNAIDS 2012, Schedule R, ISO 11737-1, IP 2018, USP 42), disposable hypodermic needles (sterility, bioburden & BET as per ISO 11737-1 &2, USP 42, EP 9.0, IP 2018, BP 2018)- Class B, C, disposable perfusion sets (physical testing, sterility, bioburden & BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 & 2, USP 42, EP 9.0, IP 2018, BP 2018)- Class A, B, C, intraocular lenses (sterility, bioburden, BET and pathogen identification as per ISO 11737- Part 1 & 2, USP 42, EP 9.0, IP 2018, BP 2018), orthopaedic implants (sterility, bioburden & BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018)- Class C, D, cardiac stents (sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)- Class C, D, contraceptives (CuT) (mechanical parameters, sterility, bioburdeen as per WHO UNFPA 2016, ISO 7439, ISO 11737-1 & 2, IP 2018, USP 42, BP 2018, EP 9.0), disposable hypodermic syringes (sterility and BET as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)- Class B, internal prosthetic replacements (sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018), heart valves (sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018), contraceptives (tubal ring) (mechanical parameters and sterility as per IS 13009-2000, ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018), IV cannulae (sterility, bioburden, pathogen identification as per ISO 11737-1 & 2, USP 42, EP 9.0, IP 2018, BP 2018).
Devansh Testing & Research Laboratory will evaluate catheters – Class A, catheters (excluding bio-compatibility testing)- Class B, C, D, disposable perfusion sets- Class A, disposable perfusion sets (excluding biocompatibility testing)- Class B, C, disposable hypodermic needles- Class A, disposable hypodermic needles (excluding biocompatibility testing)- Class B, disposable hypodermic syringes – Class A, disposable hypodermic syringes (excluding biocompatibility testing)- Class B, C, D, IV cannulae- Class A, IV cannulae (excluding biocompatibility testing)- Class B, C, D, scalp vein set- Class A, scalp vein set (excluding biocompatibility testing)- Class B, C, D, surgical dressings- Class A, surgical dressings (excluding biocompatibility testing)- Class B, C, D, contraceptives- Class A, contraceptives (excluding biocompatibility testing)- Class B, C, D, disinfectant- Class A, disinfectant (excluding biocompatibility testing)- Class B, C, D.
Jagdamba Laboratories will evaluate catheters (test as per IS/ISO 10555)- Class A, B disinfectants (as per IP, BP, USP)- Class B, disposable hypodermic needles (test as per IS 10654)- Class B, disposable perfusion sets (test as per 12655)- Class A, B, IV cannulae (test as per IS/ISO 10555)- Class B, disposable hypodermic syringes (test as per IS 10258)- Class B, scalp vein set (test as per IS 16097)- Class B, surgical dressings (cotton and gauze, bandage)- Class A, B.
ITL Labs will evaluate catheters, surgical dressings, disposable hypodermic syringes, disposable hypodermic needles, surgical dressings, contraceptives, IV cannulae, scalp vein set, disinfectant, disposable perfusion sets, surgical suture, urine collecting bag, surgical gloves, endotracheal tube, blood bag (single, double, triple, quad blood bag) etc.
Accuprec Research Lab will evaluate vascular devices & IV sets (class D), tubal rings (class C), copper T (class C), sutures (class C), disposable hypodermic needles (class C) & disposable hypodermic syringes (class B), blood bags (class B), condoms (class C), coronary stents (class D), intraocular lenses implants (class D), orthopaedic implants & devices (class D), drug eluting stents (class D), internal prosthetic replacements (class D), ablation devices (class D).
Conformity Testing Labs will evaluate NIBP (class B), IBP (class C), nebulizer (class C), thermometer (class B), and glucometer (class B).
Brothers Laboratories will evaluate disposable hypodermic needles (class B), surgical dressings (class A), disposable perfusion set (class B), catheters (class B), surgical dressings (class B), disinfectants (class B), disposable hypodermic syringes (class B), IV cannulae (class B), scalp vein set (class B).
Earlier CDSCO had notified four MDTLs– Sipra Labs Ltd, Telangana, Star Imaging and Path Lab Pvt Ltd, Delhi, Alcatec Research Laboratories India, Haryana, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvanthapuram.
Meanwhile, the Union health ministry has stepped up efforts to upgrade manpower at CDSCO towards effective licensing and enforcement activities to ensure safety, quality and performance of medical devices.
Recently, CDSCO has appointed 172 drug inspectors as medical device officers (MDO) under the new MD Rules 2017 to regulate manufacture, import, sale and distribution of medical devices.
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