June 12, 2018
In order to optimize the efficiency of approval process, China Drug Administration (CNDA) has proposed amendments for submission documents for the renewal and clinical trial application of medical devices. This notice was issued at the end of May.
The revised contents are hereby summarized as follows:
I. Annex 4 of the Medical Device Renewal Application:
"V. Provide the product analysis report containing product data which were taken within the validity period of the registration certificate" is amended to "V. If the original medical device registration license states that: ‘the report is to be completed’, then the applicants shall provide a relevant summary report of the current work along with the data available on hand."
II. Annex 7 of the clinical trial application of Medical Device:
1. Amendments were made to the requirements for the "Document II. Certificate documents";
2. Amendments were made to the requirements for the “Document IX. The hard copy of the agreement of Ethics Committee”.