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Approval for Innovative Medical Device’s Special Review and Priority Review in the First Half of 2019

222019-07

Approval for Innovative Medical Device’s Special Review and Priority Review in the First Half of 2019
After the intensive NMPA review, 7 IVD products from 7 companies successfully passed the CMDE review in the first half of 2019 (January- Jun 2019). These companies are...
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Announcement on the “Supplementary Appendix of Medical Device Manufacturing Quality Management for Stand-alone Software” (2019 No. 43)

172019-07

Announcement on the “Supplementary Appendix of Medical Device Manufacturing Quality Management for Stand-alone Software” (2019 No. 43)
China NMPA officially released a “Supplementary Appendix of Medical Device Manufacturing Quality Management for Stand-alone Software“ to tighten the manufacturing sup...
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Announcement on the Guideline for the Technical Review of the Digital Oral Impression Instruments (2019 No. 37）

082019-07

Announcement on the Guideline for the Technical Review of the Digital Oral Impression Instruments (2019 No. 37）
China NMPA has published a guideline for the digital oral impression instruments. Covered topics include the classification, product description, criteria of technical review, ...
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Announcement of China NMPA on the Result of Medical Device Review and Sampling Inspection (2019, No. 30)

082019-07

Announcement of China NMPA on the Result of Medical Device Review and Sampling Inspection (2019, No. 30)
In the effort to strengthen the review quality of medical device and improve the safety and effective use of medical device products, China NMPA carried out the sampling inspec...
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Announcement on Special Review for the Applications of Innovative Medical Devices and Priority Approval (2019 No. 7-9)

032019-07

Announcement on Special Review for the Applications of Innovative Medical Devices and Priority Approval (2019 No. 7-9)
China NMPA announced the following enterprises whose applications fully comply with the prerequisite criteria and are accepted into the special review process of innovative medi...
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Announcement on the Review Results of Special Review Application for Innovative Medical Devices

302019-05

Announcement on the Review Results of Special Review Application for Innovative Medical Devices
According to requirements of “Special Review Procedure for Innovative Medical Device”, China NMPA has announced that following enterprises being approved for Special R...
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