On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) published on its official website the Regulation of Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R 102(E) dt 11.02.2020 – Regarding. It states that as of October 1, 2023, all Class C and D Medical Devices (medium-high and high risk) must have an import licence.
The process of applying for an import licence for class C and D devices in India requires the submission of a Device Master File for each medical device to be marketed and a Plant Master File describing the organisation’s production site. Regarding the Device Master File, the registration process is largely a re-evaluation of the existing approval in other countries such as the USA, Canada, Europe, the UK, Australia and Japan. Concerning the Plant Master File, the Quality Management System of the organisation’s production facilities must comply with ISO 13485:2016.
Once the Device Master File and Plant Master File are approved, CDSCO issues the import licence to market the Medical Devices concerned in India. Thus, manufacturers with one production site will have one import licence while manufacturers with three sites will have three import licences.
The circular also states that importers who are already marketing a Class C and D device and have already applied to CDSCO for the issuance of an import licence may continue to market for up to six months from the date of issuance of the circular or until CDSCO issues the import licence.
The medical device market in India is growing rapidly and it is characterised by the demand, especially from the private sector, for high technological quality standards. For these reasons, CDSCO is increasing the requirements for marketing the devices to ensure the sale of safe and effective products and to safeguard the health of patients.
>>> If you want to market Medical Devices in India, Thema can assist you with the Strategic-Regulatory Consulting service. Thema can be your Local Representative and can support you in the registration of products with CDSCO.
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