During the registration phase, applicants may need to submit technical documents containing confidential information from subcontractors (such as raw material suppliers) to regulatory authorities. Some third-party companies (hereinafter referred to as "owners") may allow the confidential review of their technical data by the NMPA, but do not wish to disclose their technical information directly to the applicant (hereinafter referred to as "applicants").
To solve this issue, NMPA is currently developing a registration system for main dossier of raw material from medical device suppliers, which is submitted by Owners to authorize applicants to use medical device registration documents and other related requirements, without directly disclosing the content to their respective applicants.
The purpose of the “main dossier” is to protect the material’s technical information, and to avoid repeated submission of the same technical documents by different applicants.
This registration is voluntary. The domestic owners may apply for registration on its own. The foreign owner of the main dossier (including Hong Kong, Macao and Taiwan) may apply for registration on its own or entrust an agency to apply for registration.
The contents of the main dossier covers the medical device raw materials (excluding in vitro diagnostic reagents), including the raw material composition description, performance research data, biological evaluation data, and toxicological risk analysis data.
Once the main dossiers have been fully developed, the following legal actions shall be taken by the owners:
Authorization
Applicants can use the main dossier content to support applications such as medical device registration, amendment, and clinical trial application. The applicant’s grant to use the contents thereof shall be subject to the owner’s (or its registration agency) authority in writing.
Amendment
The main dossier owner may update the main dossier through the NMPA, including changes in the authorization status, changes in the agency, and any changes to the content of the main dossier.
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