Guidelines On The Registration Of Registered Class II Medical Devices Moving Into Guangdong Province

In order to continuously optimize the business environment and promote the high-quality development of the medical device industry in Guangdong Province, on August 29, 2022, the Guangdong Provincial Drug Administration formulated the Guidelines on the Registration Application of Registered Class II Medical Devices (trial). It mainly describes the scope of application and the requirements of declaration.

Applicable scope of this guidance:

For cross-provincial mergers, reorganizations, or enterprises within the same group, the products that have obtained the Class II medical device registration certificate from outside the province moving to Guangdong for registration, and the products will not undergo substantial changes.

For overseas medical device registrants, through their sole proprietorships, joint ventures or authorized provincial registration applicants, transfer products that have obtained the Class II imported medical device registration certificate to Guangdong province for registration, there is no substantial changes in the products. The above scenario is also within the applicable scope of this guidance.

The Guangdong Provincial Drug Administration establishes communication channels and organizes the review department to communicate with enterprises in need. If it falls within the scope of application of guideline, the review department will organize the inspection of the medical device registration quality management system. If the verification is passed, the enterprise submits the registration application materials and the verification results of the registration quality management system.

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