NMPA and three other ministries jointly issued a document to regulate the export order of medical devices

On March 31st, the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation issued a notice on orderly export of medical supplies: During the special period of epidemic prevention and control, in order to effectively support the global fight against the epidemic, ensure product quality and safety, and regulate export order, starting from April 1st,When enterprises exporting novel coronavirus detection reagents, medical masks, medical protective clothing, respirators, and infrared thermometers declare to the customs, they must provide the registration certificate of domestic medical devices and meet the quality standards of the importing country. At the same time, a written or electronic statement must be provided, promising that the exported products have obtained the registration certificate for medical device products in China.

Policy interpretation: Against the backdrop of recent confusion in overseas registration regulations, the Ministry of Commerce, General Administration of Customs, and National Medical Products Administration have jointly standardized the export order of medical substances, providing direction for the vast number of medical device production and operation enterprises that intend to carry out medical device export business.

Firstly, as medical devices, related products must be registered and certified domestically in order to be sold domestically and internationally; Secondly, even medical masks need to be registered as Class II devices, and registration and system assessment application materials must be submitted in order to obtain certification; Thirdly, relevant products must undergo testing by qualified institutions and obtain testing reports; Fourth, possessing export qualifications; Fifth, non-medical devices (such as ordinary protective masks) are not subject to this announcement.

As a leading provider of professional medical device technology transformation services in China, Xingyue Biotechnology can provide domestic registration services for a large number of medical device enterprises, assisting them in starting from product technical requirement writing, product testing, registration information writing and review, application and tracking, and related qualification (production enterprise license, business enterprise license) application, etc., to open up channels in various links and ensure the smooth launch of products.

Announcement Content Link：

http://www.mofcom.gov.cn/article/b/e/202003/20200302950371.shtml

http://www.nmpa.gov.cn/WS04/CL2138/376203.html