Last 26th October, the Center for Medical Device Evaluation (CMDE) of the di NMPA (National Medical Products Administration) issued the Notice of Electronic Registration Certificate, a notice announcing the implementation of the system of issuing electronic registration certificates, instead of paper certificates, for approved Medical Devices as of 1st November 2022.

Initially, electronic registration is only possible for new or amended licences of domestically manufactured Class III Medical Devices and Class II and III Medical Devices imported into China.

The Notice of Electronic Registration Certificate also clarifies that the electronic certificate has the same legal effect as the paper certificate and it is only issued after authentication of the Manufacturer’s real name.

This is a significant change from the previous NMPA arrangements, but also a big step forward for foreign Manufacturers, who often do not realise the importance of keeping the original copy of the paper certificate as proof of the correctness of the registration information of any changes made.

In fact, previously, each time a change was made, a physical hard copy was required so, for example, losing or not having it could create problems during the renewal or modification phase. Now, with the requirement for a digital Certification Authority certificate (CA certificate), the product cycle’s management, from submission to post-marketing, is handled centrally and electronically by NMPA.

>> Need support to market your devices in China?

Rely on Thema’s experts for strategic-regulatory consulting and international extra-EU registration services. Thanks to constant professional development, Thema’s professionals will enable you to access the Chinese market faster and more competitively.

>> Do you want to be independent from your Chinese Distributor?

Choose Thema as your Local Representative (Legal and Service Agent) and you will be independent in the regulatory process: you will not have to fear obstacles to the marketing of your devices in the event of a break in the relationship with your Distributor and your business opportunities will increase if you want to involve other sales partners for such a large territory.

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