Is It Required To Apply For Change Of Permission Items For Any Change In The Instruction For Use?

The changes of the IVD reagent instructions for use include two kinds of conditions: textual changes in information content and other content changes.

1. Textual changes in informational content.
   In accordance with the Notice of the General Office of NMPA on Issues Concerning the textual Changes of the In-vitro Diagnostic Reagents Instructions, the textual changes in the informational content can be modified by the registrants themselves.
   Including:
   The changes about the information under the item of [Basic information] in the instructions, such as the contact details of the registrant or the manufacturer of the IVD reagents, the name and contact details of the after-sales service company, the production license number or the production filling certificate number, the contact details of the agent for imported products, can be modified by the registrant himself. Among them, the production license number or the production filling certificate number should be revised after being issued by the corresponding provincial authorities.
   The changes about the information under the item of [Medical Device Registration Certificate Number/Product Technical Requirement Number] can be modified by the registrant itself, if the changes are because of the corresponding issuing of the medical device by NMPA.
   The changes about the information under the item of [Explanation of the logo] can be modified by the registrant itself if the changes are caused by the registrant optimizing the interpretation of the corresponding logo according to the series standards of YY/T 0466, not involving other situations that require changes of permission items. Here, the series standards of YY/T 0466 and its corresponding ISO 15223 standards are all applicable. If the registrant makes the above changes on its own, it should be explained when the registration is renewed.
   The changes about the information of other medical devices or IVD reagents that the product must be used in combination with, as listed under the item of [Main components], can be modified by the registrant itself if the changes are because of the issuing of the medical device registration certificate/filling certificate by the corresponding drug supervision and administration department which results in the changes of the registration certificate/filling certificate number.
2. Other content changes
   As the instructions for use of an IVD reagent is an attachment to the registration certificate, the content of it should be regarded as the content of the registration certificate.
   In addition to the above textural changes of informational content, other content changes should be amended through the application for change of permission items.
   The pathway of notification of changes of the instructions for use does not apply to IVD reagents.