We first visited this issue last month (see here for the earlier post). But the CFDA has now made clear the nature and scope of the planned update.
The new catalogue is divided into 22 subdirectories according to the technical and clinical characteristics of the medical device. The subdirectory consists of the following:
- a product category;
- a secondary product category;
- a product description;
- an intended use;
- a product name example;
- and a management category.
Furthermore the new “category directory” framework and content is greatly adjusted. The medical device registration, production, management, use and other relevant matters will all be impacted. In order to ensure a unified understanding of all parties and a smooth transition as well as a good order of the implementation, the CFDA also issued “Notice relevant to the implementation of the new revision of the medical device classification catalogue”, giving a nearly one-year transition period.
The implementation plan outlines the specific dates and deadlines associated with the new catalogue and also how the agency will manage new and existing registrations.
What happens if my device is reclassified?
Once the new catalogue is in place (effective August 1, 2018), all renewals/applications will need to be done in accordance with the new “classification” catalogue. Any renewals submitted and accepted prior to August 1, 2018 will be issued with a medical device registration certificate in accordance with the original “Catalogue”. Some key points are:
- Any down classified products shall have a new application submitted in accordance with the new catalogue within 6 months of the expiry period of the medical device registration certificate.
- Where the products classification risk has increased and the certification is due for renewal within the transition period, the registrant may submit an application for extension of the certificate. The extension shall not exceed 31 August 2019.
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