Medical Devices

What are the assessment criteria and approval scope for package inserts of imported medical devices? How to apply for subsequent modifications?

刊登日期:2019-07-11  |  點閱次數 : 677 次 

For a medical device license registration, the original foreign package insert must be attached as the fundamental reference to the Chinese package insert. However, the information in the original package inserts may not be included in the Chinese package insert in the condition of: (1) content that is not applicable for Taiwan; (2) inappropriate claims; (3) claims that are not substantiated with sufficient evidence. Therefore, the approval scope of a medical device license is limited to content description in the Chinese package insert only. The original package insert is not part of the Chinese package insert (see Note*) and is kept in the case file folder for future reference.



If the users are restricted to health professionals only, transferred into the Chinese package insert of the Chinese package insert include a statement as “Please read the original manual carefully before using the product and follow the instruction when using the product.” In this acre, the original package insert is stapled with the Chinese Package Insert by the authority.

If an updated to the foreign package insert is available in the future and the update has no impact on contents of the Chinese package insert version, the pharmaceutical firm can keep a copy of the updated foreign package insert for own reference. It is not necessary to submit an official application for this type of change. This administrative principle is also applicable to previously verified package inserts with an attached foreign version.

Same condition also applied to *Note

For detailed information about package insert assessments, kindly refer FDA announcements dated June 2, 2011 “Package Insert Assessment Criteria for Imported Medical Devices,” “Package Insert Assessment Criteria for Imported Medical Devices and the Application for Subsequent Modifications ” dated August 10, 2011.



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