How To Understand The Requirements For The Change Of Permission Items Of Suppliers For Major Materials?

Article 58 of Chapter VH of the Provisions for In-vitro Diagnostic Reagent Registration provides that, “If the following changes occur in the contents of the registration certificate and attachment, the applicant should apply to the original registration department for changes of permission items: 1. Changes in suppliers of major materials such as antigens and antibodies/5 The implementation of this clause is explained as follows:

1. The change of permission items mentioned in this article is only for the situation where the main raw material suppliers explicitly stated in the appendix to the product technical requirements attached to the registration certificate are changed.
   Regarding the changes of other raw material suppliers that are not specified in the registration certificate and its attachments (including the case that the products technical requirements for the second category of IVD reagents have no attachments), the registrant may conduct research and verification on the changes, and perform the management and quality control through the quality management system, without applying for changes of permission items.
2. This Article is only for the situation where the supplier of major materials such as antigens and antibodies is changed. If the major raw materials themselves change, for example, antibody clones change, it does not belong to this change item.