New Update on Medical Device Testing Laboratory:
As per the news released on November 23, 2022, four more medical device testing laboratories (MDTL) approved by CDSCO, to evaluate and carry out the testing of medical device on behalf of the manufacturers. So now the total number of MDTLs across the country is 28. The four new laboratories are situated at Andhra Pradesh, New Delhi, Haryana, Udaipur Rajasthan. The expansion of MDTL (Medical Device Testing Laboratories) is important for the growth of the medical device industry with the emphasis of quality and safety of the devices. For more details check the reference link :
The medical device market of India is among top 20 in the world. Manufacturers of medical devices need to register themselves with CDSCO manufacturing license. While completing this step by step process the manufacturer needs testing and evaluation of their devices, and to make it easy CDSCO updates the list of MDTL (medical Device Testing Laboratories). The 18 MDTL have been registered with CDSCO till 2021 under the provision of MDR 2017.
Now CDSCO has published an updated list of MDTL under the provision of MDR 2017. The reference link below will take you to CDSCO website where you can check the new list MDTL.
Here we are briefing you about the previous MDTL updates and links
Central Medical Device Testing Laboratory
Central Government designates laboratories as Central Medical Device Testing Laboratory under MDR, 2017. These laboratories are being set up to provide a boost to the domestic manufacturing sector by providing adequate infrastructure for device testing based on project proposals and technical support given by the National Health Systems Resource Centre (NHSRC), a technical support institution under the health ministry.
Central Government in pursuance of the powers conferred by sub-rule (2) of rule 19 of the Medical Devices Rules, 2017, hereby designates these five laboratories having facilities for carrying out test and evaluation of medical devices, as Central Medical Device Testing Laboratory for the purposes of (a) testing and evaluation; (b) functioning as an appellate laboratory; and (c) to carry out any other function as may be specifically assigned to it by the Central Government, in relation to the medical devices.
The laboratories designated are duly accredited by the National Accreditation Body for Certification Laboratories. As per the new notification released by CDSCO on 3rd Oct 2019. List of Medical Devices Testing Laboratory (MDTL) for carrying out test or evaluation of Medical Devices on behalf of manufacturer registered with CDSCO under MDR 2017 Regulation.
The Update list of Medical Devices testing laboratories registered with CDSCO up till under rule 81 in the provisions of Medical Device Rules, 2017 to carry out test or evaluation of a medical device on behalf of manufacturer is given below % there are more applicants which are under evaluations.
27 AUG 2021
As you are aware that Medical Devices Rules 2017 has already been published vide G S R 78(E) dated 31.01.2017 under Drugs and Cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01.01.2018. 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 manufacturer is given below & there are more applicants which are under evaluation.
Reference link – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzYyMQ==
