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与COVID-19疫情有关的医疗器械出口的新要求

The Ministry of Commerce, the National Medical Product Administration (“NMPA”) and the General Administration of Customs jointly issued an announcement on 31 March 2020 regarding the export of medical devices related to COVID-19 epidemic.

According to this announcement, as from 1 April 2020, all Chinese enterprises which export COVID-19 test products, medical masks, medical protective clothing, ventilators and infrared thermometers, shall provide a written or electronic statement as attached in that announcement to warrant that the medical devices products they export have been granted the medical devices products registration certificates, and comply with the quality standards of countries/regions where the products will be imported.  The customs shall only release the products at the time of export after checking the medical devices registration certificates.  The said announcement further stipulates that these measures will be adjusted according to the development of COVID-19 epidemic.

Before that announcement was issued, medical devices registration certificates were not required for the majority of the exported medical devices products. Article 44 of the Medical Devices Administration Regulation effective as of 1st June 2014 provides that the enterprise which exports medical devices shall make sure that the products it exports shall comply with the requirements of the countries/regions of importation. That regulation does not require such products to be in compliance with the Chinese standards in case of export.  

The above announcement implies that as from 1st April 2020, these medical devices as mentioned in this announcement shall not only comply with the standards of the country/regions where such products will be imported but also withthe Chinese standards. .

To clarify the purpose of this announcement, the NMPA also published on its website that the purpose of this announcement is to strengthen the control of the quality of the medical devices for COVID-19 epidemic in the world and to severely control the quality of the products is extremely important at this period of time.

If the medical devices to be exported have only passed the certification according to the standards of the country/region of importation but have not been granted with the medical devices registration certificates, a prior application for registration should be made with the NMPA in China to obtain the registration before export .  

To show the immediate actions following this announcement, the General Administration of Customs have published three cases of sanctions decisions made by the customs of Shanghai and Ningbo following the issue of this announcement on its website.

Also, the local bureau of commerces of some cities suggests the Chinese companies to include relevant clauses in their sales contracts stipulating that foreign companies recognizethe fact that the exported products comply with the Chinese standards and if such products do not comply with the standards of the countries/regions, they suggest to specify in the relevant sales contracts that such obligation should be exempted by the foreign companies in case the foreign companies would like to place orders for these products.

Therefore, foreign companies which wish to purchase these medical devices products from Chinese suppliers should pay attention to these new requirements. It is strongly advised that they should check and request the related medical devices registration documents in China from the suppliers and/or verify the related information on the website of the NMPA, in order to prevent any potential regulatory risks at the time of exporting these products from China.  They should also carefully check the related contracts to be signed with the Chinese companies with regard to these requirements.

作者

Nicolas Zhu
朱 王强
合伙人
上海