CDSCO Guideline Approved for Medical Devices Safety & Performance

CDSCO guideline approved under the Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. One of the major functions of CDSCO is approval of new drugs in the country. During the month of March 2018, CDSCO guideline was approved on the following issuance of the CDSCO guidelines under the provisions of the Medical Devices Rules, 2017 on Essential Principles for safety and performance of medical devices CDSCO. 

The new medical device rule “MDR 2017, India” has come into result from January 2018. Under control with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance paper, CDSCO guideline report and various other important updates to allocate unalterable guidance for use in the manufacturing and registration of medical devices which are planned to be sold in India. Just like that, CDSCO has released a new draft guidance document, which concisely highlights the essential principles for safety and production of various medical devices (MDs) based on rule 6 of MDR 2017.

It is essential to mention that IVD medical devices have been divided from medical devices in the new rule although the classification for each type follows class A, class B, class C, and class D categories. There are some important principles declared for all MDs including IVDs and some important principles for MDs except IVDs whereas some are substantially made for IVDs.

Important principles for all classes of MDs mostly highlight on the fact that it should be planned and manufactured in such a way that they will perform as intended by the user without compromising the clinical conditions and safety of patients. Every medical device needs clinical evidence, appropriate for its intended use and categorization of the medical device, demonstrating that the device follows with the applicable provisions of the important principles.

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