CDSCO approves SCTIMST as Medical Device Testing Lab
New Delhi: Through a recent notification, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has given its approval to medical devices testing laboratory (MDTL), including Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) for carrying out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under Medical Devices Rules 2017.
CDSCO has given approval to the institute to conduct the Biological Evaluation of medical devices; such as cardiovascular devices, neuroprosthesis, orthopaedic implants, dental implants and all other medical devices and materials as per ISO 10993. SCTIMST is already certified by an international agency COFRAC, France, for testing and evaluating medical devices.
The approval for this registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017. Medical Devices Rules 2017 has been published under the Drugs and Cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices.
Medical devices, under the new rules, classified as per the Global Harmonization Task Force (GHTF) practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate-high risk) and Class D (high risk).
The updated list of medical devices testing laboratories registered with CDSCO up till under rule 81 in the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a medical device on behalf of the manufacturer reads;
|NAME & ADDRESS|
OF MEDICAL DEVICE TESTING LABORATORY
|REGISTRATION NO.|| |
SCOPE OF TESTING
|1||M/s SIPRA LABS|
Address: 7-2- 1813/5/A, Adj. To Post Office, Industrial Estate, Sanathnagar, Telangana,
|TL/MD/2019/000001||1. Copper -T|
3. Sterile Hypodermic Needles
4. Tubal Rings
S. Hypodermic Syringes
6. Blood Bags
|2||M/s Star Imaging &|
Path Lab Pvt. Ltd. Address: 4B/4, Tilak Nagar, West Delhi, Delhi (India) - 110018
|TL/MD/2019/000002||1. Bilirubin (Total and Direct) Test|
Reagents / Kits
2. Creatinine test reagent/kit
3. Aspartate Amino Transferase (AST / SGOT) test
4. Alanine Amino Transferase (ALT/SGPT) test
5. Uric Acid Test reagents/kits
6. Total Protein test reagents/kits
7. Activated partial thromboplastin time (APTT) test
8. PT (Prothrombin Time) Test reagents / Kits
|3||M/s Alcatec Research Laboratories India Pvt. Ltd.|
Address: 1652 MIE Part B, Bahadurgarh, Haryana — 124507
|TL/MD/2019/000003||1. Sterilized Surgical Ligatures|
2. Sterilized Disposable Device
3. Sterilized Surgical Sutures
|4||M/s Sree Chitra Tirunal institute For Medical Sciences fi Technology Address: Medical College, Thiruvananthapuram, Kerala - 695011||TL/MD/2019/000004||1. Cardio Vascular DeVices (Biological Evaluation as per ISO 10993)|
2. Neuroprosthesis (Biological Evaluation as per ISO 10993)
3. Orthopedic Implants (Biological Evaluation as per ISO 10993)
4. All medical devices and Materials (Biological Evaluation as per ISO 10993)
|5. Dental Implants (Biological|
Evaluation as per ISO 10993)
More applicants which are under evaluation, add the notice.