Interpretation Of SFDA Registration Regulation For Medical Device No. 409 -2
On July 23rd, 2008, “the Provisional Requirements for Future Enhancement and Standardization of Medical Device Registration, Promulgated by the SFDA, was implemented. A new SFDA registration requirement for medical device has been conducted. Now we makes introduction to the two cases that do not belong to "re-registration items with no changes". And the requirements for re-registration are different:
A. Where it is only related to literal changes to the product standards and insert sheets in accordance with provisions in the Provisions for SFDA Registration for Medical Devices and the Notice on Related Items on Alteration Application for SFDA Registration for Medical Device Certificate (Guo Shi Yao Jian Xie [2007] No. 778), the changes are included in the category of insert sheet for record or altered registered documents. The manufacturers do not have to submit the testing report of their products when they apply for re-registration, but they shall submit relevant materials according to the requirements of insert sheet for record or literal alteration, so that the work concerned "record" and "alteration" can be completed at the same time, work procedure being simplified and the contents of registration certificate being guaranteed same with the application documents.
B. Some products have not been changed in the aspect of the designs. However, with the improvement of national/industry standards, their registered product standards are required to make corresponding revision based on the renewed national/industry standards. In this case, SFDA re-registered application should be performed in accordance with the Article 4 in the Provisional Regulations concerning registered items with changes to product standards or insert sheet, i.e., "manufacturers should submit, in addition to the application dossier required by relevant regulations, the contrast tables and supporting data of the products, product standards and insert sheet before or after the alteration."
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Related Report: Interpretation of SFDA Registration Regulation for Medical Device (No. 409)-1
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