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OSMUNDA Successfully Assisted the Enterprise in Acquiring the Approval for Urgently Needed Medical Device

242020-01

OSMUNDA Successfully Assisted the Enterprise in Acquiring the Approval for Urgently Needed Medical Device
China has recently confirmed human-to-human transmission of a novel Wuhan coronavirus strain (2019-nCoV). As in January 24th, more than 850 cases of pneumonia-linked coronaviru...
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NMPA Notice: New Clinical Trial Exemption List for Medical Devices and In-vitro Diagnostic Products

302019-12

NMPA Notice: New Clinical Trial Exemption List for Medical Devices and In-vitro Diagnostic Products
On December 23, NMPA published new catalogs of medical devices and IVDs products which are eligible for the clinical trial exemption when applying for the product registrati...
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NMPA Notice: Guideline Draft on the Usage of Real-world Data in Clinical Evaluation

172019-12

NMPA Notice: Guideline Draft on the Usage of Real-world Data in Clinical Evaluation
On December 13, National Medical Product Administration (NMPA) of China released a draft (Guideline on the use of real-world data in clinical evaluation). NMPA has fo...
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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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