India expands registration requirements for imported medical devices

India’s Central Drugs Standard Control Organisation (CDSCO), a body responsible for regulating the import and approval of medical products and clinical trials, has expanded its list of medical device categories that must be registered prior to importation.

The CDSCO has added 8 new categories to its list of around 50 medical devices; bone marrow cell separators, CT scan equipment, defibrillators, dialysis machines, implantable medical devices, MRI equipment, PET equipment and x-ray machines. Devices within these categories must obtain import licenses from both the manufacturer and importer and, should they not comply with this requirement within the next year, would be barred from importation and sale from 1st April 2020.

Medical devices that do not fall within these categories must obtain a ‘No Objection Certificate’ (NOC) from the Drug Controller General of India (DCGI).

These changes aim to strengthen the regulation and traceability of medical devices, thereby improving patient safety, and complement plans to separate medical device and pharmaceutical regulations.

For further information please read the CDSCO’s draft ‘Standards for Medical Devices – A Reference Document’, the first such document compiling requisite information relating to legal, regulatory and quality requirements for medical devices. You can also read their medical device guidance documents here.

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Published on 7. March 2019 in News