China allows overseas medical devices import without registration into the country due to the coronavirus emergency

Due to the coronavirus emergency, the China National Medical Product Administration has issued an opinion letter for openning the import of overseas medical devices which can be used during the coronavirus emergency. The medical devices do not need to be registered in China, but show the compliance to the standards in the US, EU, or Japan. For importing, the overseas approval, testing report and the declaration to ensure the product quality and safety shall be provided.

Although relevant device types are not defined in this letter, the NMPA hand the discretion over to the province-level MPA to identify whether the devices are needed in the coronavirus emergency. In general, the protection devices, devices used for hygiene, devices needed in ICU, devices in respiratory field shall be relevant to this letter.

So far, the province-level MPAs like Beijing, Hubei, Chongqing, Yunan, Gansu, Jilin have issued importing procedures according to the opinion letter from the NMPA.

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The full text of this opinion letter of NMPA letter is translated as below:

Opinions on urgent import of medical devices not registered in China

In order to meet the needs of epidemic prevention and control, medical devices that meet the relevant standards of the United States, the European Union and Japan are urgently imported from abroad. If the enterprise can provide the overseas medical devices with certificates and inspection reports, and make the product quality and safety commitment, it can be used in emergency.
If it is deemed necessary to import under the joint prevention and control mechanism at the provincial level, please ask the provincial drug administration to cooperate with the departments of industry and information technology, industry and health, customs and other departments to complete the customs clearance of imported products, and issue the import certificate of this batch of materials as the case may be.