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21 juni 2021

How to register your medical devices in China

China has a very potential market for your medical devices mainly due to a large population. Moreover, especially for the innovative high-end devices, China still relies on import. The export of your medical devices to China is one of the market entry modes. It allows for faster market entry and requires relatively lower capital investment.

As in Europe, China imposes rather strict rules on medical devices than on other products as those are human health-related and risks involved. Medical devices in China are mainly regulated by the National Medical Products Administration (NMPA), which has been recently revised and has taken effect as of June 1, 2021.

Prior to commercializing your medical devices in China, you need to register your devices, or namely obtaining certain approvals from the NMPA according to the NMPA regulation. The revised regulation to a certain degree simplifies the procedure. Generally speaking, the following steps need to be taken for the registration of your medical devices at the NMPA.

1. Determine the classification of your medical device in China.

The medical device can be classified as class I, II and, III based on the different risk levels involved.

For class I (low risks), such as biological microscope, bandage, record filing at the municipality level is sufficient. Record filings undergo only a completeness check upon submission.

Medical equipment such as ultra-sound equipment should be categorized as class II (moderate risks), lung ventilator equipment is categorized as class III (high risks). For those relatively higher risk classes, stricter rules apply. You must submit more extensive documentation to the provincial level or state council. The authorities will perform comprehensive technical reviews.

2. Appoint an Agent located in China who will coordinate your NMPA device registration.

For this you can engage a third-party local agent or your own subsidiary in China can also represent you to communicate with the NMPA and be responsible for the maintenance of the certificate after approval etc.

3. Prepare and submit supporting documents.

Please note that all documents should be submitted in Chinese.

1) document which can demonstrate proof of home country approval.
Such as CE mark (Conformité Européenne).

Under the new regulation, innovative imported medical devices can get an exemption. Those innovative medical devices not previously marketed overseas do not have to submit home country approval.

2) prepare product technical requirement document.

3) prepare a testing report.
Before, for classes II and III, you had to send devices to China for testing to be carried out by an authorized test center. But under the new regulation, this may be exempted, the applicant may submit the report made by himself.

4) prepare clinic evaluation, where applicable.

5) prepare labeling sample, product specification etc.
Where there is no Chinese instruction or label, or the instruction or label does not conform to the provisions of the regulation, the medical device can not be imported.

Following a successful review, the authority will issue certain certificates to you and publish it online, which enables the commercialization of your products in China.

Supplemental rules and guidelines with regard to medical devices will be gradually released, and details might vary in different regions and provinces. Please consult with us if you want to register your medical devices in China.

More information

If you need further information, please do not hesitate to contact our Asia team: Joost Vrancken Peeters at +31620210657 or jvp@lgga.nl, or Ye Yu at +31639267995 or y.yu@lgga.nl.