India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and importers of non-notified medical devices for registering their products.
The guide details the importers and manufacturers of non-notified medical devices to a website where they can upload documents required to register on the portal, such as a copy of the manufacturing or wholesale licenses.
The rest of the guide covers the different sets of documents that manufacturers and importers need to provide to register their medical devices.
Both sets of companies need to provide a certificate of compliance with ISO 13485, which covers quality management systems, “accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.”
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