Overview:
China’s Center for Medical Device Evaluation (CMDE) released 2 announcement revising medical device registration procedures. CMDE establishes procedures and requirements that provide further standardization of the administrative filing review for registration applications, including the acceptance of corrections.
CMDE New Requirements:
- The instrument review center will conduct data review in accordance with the requirements of the file examination during the acceptance process. If it involves the correction of data, in principle, the one-time compensation request shall be implemented.
- After receiving the correction opinions, the applicant/registrant shall modify and perfect the application materials according to the correction opinions and submit the corresponding registration application again after the self-examination is correct.
- During the file review, the Appraisal Center will provide better services and improve the efficiency of the review. It will also put forward preliminary opinions and suggestions related to the technical review and write it as a reminder in the review reminder of the acceptance and correction notice.
Registration withdrawal and re-application procedures for imported medical devices
Exiting a registration process under review:
If the evaluation is confirmed as the third category, it will issue a review conclusion that will not be registered and will be included in the comprehensive comments and remarks column of the review report. This is because
“The applicant applies for product registration according to imported second-class medical devices and is confirmed as third-class medical devices after technical review”.
re-applying for product registration:
After receiving the medical device/in vitro diagnostic reagent non-registration approval document, the applicant should confirm whether it correctly stated the reason for non-registration. A copy of the approval document should be submitted together with the application materials and the relevant information on re-application for product registration will be explained in the application form “Other Issues Needing Explanation”.
According to the requirements of the second paragraph of Article 2 of the Medical Device Product Registration Fee Implementation Rules (Trial), the difference fee shall be paid. “, and when issuing acceptance opinions, select “Supplement Fee” in “Acceptance Notification Options” to generate a payment notice.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at info@globalregulatorypartners.com