INDIA: Operational guidance for medical devices and IVDs

Guidance for medical devices (MDs)

To support all the stakeholders in the implementation of the Regulation on Medical Devices 2017 , which came into force last January, CDSCO (Central Drugs Standard Control Organization), the reference Indian Regulatory Authority, issued a draft guidance – the first of its kind. This document defines the regulatory requirements, the classification system of medical devices, the roles and the responsibilities of the Regulatory Authorities, Notified Bodies and Accreditation Bodies, the process and the information required for the registration of the MDs in India, as well as the applicable quality standards.

Guidance for in vitro diagnostic medical devices (IVD)

In compliance with the Regulation provisions* and upon request from the Regulatory Authority, the registration applicant of a new in-vitro diagnostic medical device must submit a Performance Evaluation Report (provided by the manufacturer and issued by accredited laboratories) for the device in question. The new Guidance identifies for each type of IVD the list of laboratories (testing facilities) accredited to perform these tests.

CDSCO will change its name

CDSCO will sono change its name and its own logo. As for the name change, “National Drug Authority (NDA)” and “Central Drug Authority (CDA)” among the proposals.

 

NOTE: * Clause (h), Paragraph (ii), Part II, Fourth Schedule of the Medical Devices Rules 2017

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