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Notice of the National Medical Products Administration on the Issuance of Guiding Principles for Conditional Approval of Medical Devices for Market Launch (No. 93 of 2019)

To implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, address clinical treatment needs for serious life-threatening diseases, and accelerate the review and approval process for relevant medical devices, the National Medical Products Administration has developed the Guiding Principles for Conditional Approval of Medical Devices for Market Launch (see attachment). These principles are hereby released.

Notice of the National Medical Products Administration on the Issuance of Guiding Principles for Conditional Approval of Medical Devices for Market Launch (No. 93 of 2019)

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Regulations on the Management of Medical Device Instructions and Labels

The “Regulations on the Management of Instructions for Medical Devices and Labels” were reviewed and adopted at the Bureau Meeting of the State Administration for Food and Drug Administration on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

Regulations on the Management of Medical Device Instructions and Labels

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Medical Device Registration and Management Measures

The “Administrative Measures for the Registration of Medical Devices” were reviewed and approved at the Bureau Meeting of the State Administration for Food and Drug Administration on June 27, 2014. They are hereby promulgated and shall take effect as of October 1, 2014.

Medical Device Registration and Management Measures
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Rico International (Beijing) Medicine Technology Co., Ltd.

Tel: +86-10-53329998

Address: Room 905A, Building B, East Zone, Jianwai SOHO, No. 39, Middle Section of East Third Ring Road, Chaoyang District, Beijing

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