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China’s NMPA Begins Issuing Registration Certificates Electronically
Published on: November 1st, 2022
On October 26, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) issued a notice announcing the implementation of electronic registration certificates for approved medical devices. Starting today, November 1st, 2022, the NMPA will only issue electronic registration certificates, replacing paper certificates entirely. Initially, electronic registration will only be issued to domestic Class 3, as well as imported Class 2 and Class 3 medical device licenses. This also applies for registration changes which are approved in China. The details of the new protocol can be found on the NMPA Website here.
For questions about this new process, contact us here.
China Renewal Process
Medical devices are valid for 5 years in China and will need to be renewed at the end of this period. The original registration certificate and any change notification licenses will need to be submitted as part of the renewal application.
While most applications are renewed through an administrative process requiring the original certificate, products with updated requirements will need to also show evidence of conformity to the new standards. For example, electromedical device manufacturers should also ensure their test documents are up to the newly implemented requirements. More information on this topic can be found here.
Certificate Issuance Update
This is a significant shift from the NMPA’s previous process. Previously, a physical paper copy of the registration certificate would be needed each time an amendment was made, which necessitated keeping track of a series of physical documents in order to ensure the correct changes were made.
The electronic documents will have all the same legal effects as the prior paper certificates. Additionally, they will also include functions previously unavailable, including instant delivery, SMS reminders, license authorization and online verification. Manufacturers will need to register under the “My License” section on the NMPA’s online service hall in order to view and download the electronic certificate. The certificate can also be accessed via the NMPA app.
Physical or electronic certificates need to be submitted along with any change notifications or renewals.
License Transfer Process
This is a significant change to the Chinese medical device license transfer process, an involved sequence of events that requires adhering to a series of protocol and the submission of several documents. It typically takes about 2 months to transfer China Legal Agents. Below is a document list, that will need to be signed and notarized. The client only needs to provide the scan copy of the NMPA registration certificate.
- Application Table
- Declaration of Standard Conformity
- Declaration of Authenticity
- Declaration of Conformity
- Letter of Authorization for Legal Agent
- Letter of Undertaking by Legal Agent
- Copy of l registration certificate and its attachment, copy of previous change documents
- Declaration of Change
- Declaration of Legal Agent Change
- Copy of Business License of Agent
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If you are interested in more information on the NMPA’s shift to electronic certificates, please contact us today to speak to an experienced, bilingual regulatory expert to address any questions or provide support.
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.