India: More medical device testing facilities have been added to DCGI

ARQon
Jun 24, 2022
2 min read

Providing better assistance in obtaining medical device or in vitro diagnostic device (IVD) testing to be done in an easier and smoother way, the Drug Controller General of India (DCGI) has disclosed that the list of Medical Device Testing Laboratories (MDTLs) has been modified which currently comprises of 21 MDTLs registered with the Central Standards Monitoring Authority Medicines (CDSCO). Medical devices and IVD devices are coordinated by DCGI within CDSCO, which is a sector under the Department of Health and Family Welfare.

Under the arrangements of India’s Medical Devices Rules, 2017 (MDR 2017), MDTLs are accredited to oversee and carry out the testing or evaluation of medical device in support of the manufacturer.

The inclusion of three new MDTLs to the list regarding on accessible testing laboratories should come as fantastic news to the manufacturers doing businesses in India who are handling medical devices and IVD devices.

Emerging medical device regulations in India

India is among the list of top medical device markets worldwide. According to a recent report released available in Perspectives in clinical research, it is originally valued at $5.2 billion (USD) and is forecasted to reach $50 billion (USD) by 2025.

Prior before 2005, there were hardly any medical device guidelines in India. Nevertheless, specific types of medical devices have become subordinate to regulations under the Medical Device Rules. The CDSCO occasionally adds products to the list of regulated products, spite of the fact that the list is very comprehensive. The first step towards access to the market in India is to ascertain if your medical device is supervised by the CDSCO.

India medical device registration requirements

Medical device manufacturers who want to license their medical devices in India must show evidence of authorization in the domestic markets. Certain regulatory standards can be alleviated by introducing substantial records of prior regulatory certification in the United States, Canada, Europe, Australia, or Japan.

Every technical documentation must be introduced to the CDSCO for inspection. Furthermore, all of your device manufacturing facilities must always be licensed.

Source:

Central Drugs Standard Control