The Central Drugs Standard Control Organization (CDSCO), a medical and healthcare regulatory body in India, announced the publication of new guidelines for the regulation, marketing and licensing of medical devices. According to the Emergo Group, an initial analysis of the new guidelines shows that regulatory processes in the country remain mostly the same. However, there are several small changes that should be heeded by manufacturers.
According to the regulatory notice, generic and model names for medical devices must be listed on all power of attorney filings. Information about a medical device’s shelf life must also be included. In addition, current licenses may require amendments or other modifications before the CDSCO allows importation of a device.
There have also been changes in the certification process for new medical devices. In the future, all certificates for new medical devices submitted to India’s Drugs Controller General must be valid for a minimum period of six months following submission. In addition, all certificates must list sites where a device was manufactured. Manufacturing facility information must include addresses, names and other legal information. Information on product names, model names and generic names must also be included as required.
According to the new guidelines, the requirements for product re-registration are the same as the requirements for a new medical device. In the future, manufacturers are required to submit a copy of Form 41 with a re-registration request.
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