Bryan Gilburg - China

This extension gives manufacturers additional time to provide query responses and supplementary documents before their application is timed out.

Albert Pranoto

Director of Business Development (Singapore)

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sign Up For Our Newsletter to Stay Informed

China CMDE Supplementary Documents Submission Deadline Extended

Published on: April 11th, 2023

On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months. Supplementary documents refer to information or documentation required for IMDRC application approval but missing from the current application. These documents must be submitted by the manufacturer to achieve registration.

Therefore, manufacturers that have received queries from the NMPA and requests for additional supplementary documents pertaining to an ongoing application have considerably more time to respond than under usual circumstances. The notice can be found on the CMDE website.

This deadline applies to all devices with applications still under review and submitted prior to February 20th, 2023. For notices issued in February 20th, 2023 onward, the deadline for submission is one year.

This is in accordance with the “Measures for the Administration of Registration and Filing of Medical Devices” and the “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents” from the CMDE.

If you have further questions or require support submitting supplementary documents to China’s CMDE for your medical device, please contact us here.

Reduced Risk of Repaying $30,000+ CMDE Application Fee

If manufacturers fail to submit the supplementary documents within the year, the review process will end and the NMPA will reject the application. Manufacturers will then need to re-apply and pay the registration fee which ranges from 210,000 RMB (~US$30,500) for Class II devices, to 308,800 RMB (~USD$45,000) for Class III devices.

Additionally, if it is found during the registration process that there are elements of the application where the manufacturer has provided false information or concealed the truth, the application will be cancelled.

Importantly, there are two phases to the submission of supplementary documents, first during the initial registration application acceptance stage where the CMDE will review if the documents are complete. The second is the stage where the CMDE will ask for supplementary documents to fully prove the safety and effectiveness of the product. At this stage, the CMDE will list all questions and require all materials to be submitted at one time.

This is critical, as there will only be one year long period in which the submission of supplementary documents is permissible. If all documents requested are not submitted during this time frame, the NMPA will reject the application.

Supplementary Document Submission Deadline Extended by One Year

This notice clarifies the timeline on supplementary document submission and comes in direct response to the CMDE’s previously published notice from February 2022 regarding the renewal application.

The first announcement extending the submission deadline of supplementary documents for medical devices was in 2020 during the pandemic, when the CMDE ruled that applicants should be granted leniency in providing the additional documentation on time and given the option to submit within “three months from the date when the pandemic is lifted.”

Since the situation lasted longer than the CMDE originally anticipated, this update comes once again to relieve the pressure for applicants to submit supplementary documents for their medical devices until a year after their initial application.

The typical timeline for the submission of supplementary documents is within one year after receiving the notice from the NMPA.

It is necessary for registrants/applicants to be in compliance with the guidelines set forth in the most recent notice from the CMDE and to seek clarification/support from regulatory institutions if they have further questions about the situation.

Come Grow With Us

Whatever the situation, Asia Actual has regulatory experts throughout Asia ready to help your device expeditiously achieve market access and begin, or continue, growing your sales in the region.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

 

Blog Posts

Map showing Vietnam where updates to CSDT are taking place.
Map showing Vietnam where updates to CSDT are taking place.
Map showing Vietnam where updates to CSDT are taking place.

Vietnam’s MoH Updates Class C and D Application Requirements

Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.