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Post-Market surveillance, personalized medical devices and Cybersecurity - IMDRF guidance documents April 2023

272023-04

Post-Market surveillance, personalized medical devices and Cybersecurity - IMDRF guidance documents April 2023
The IMDRF was properly established in 2011 and have members from around the world. Representatives for, the medical device authorities of Australia, Brazil, Canada, China,...
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MDSAP Audit approach guideline update

142023-04

MDSAP Audit approach guideline update
Last April 1st, 2023, was issued an updated version of the MDSAP Audit approach applicable to all country members of the program: Therapeutic Goods Administration of Aust...
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Extension of CE Certificates and UK MHRA

052023-04

Extension of CE Certificates and UK MHRA
As a result of the EU Commission amendment on implementing extensions of the transition periods regarding the medical device regulation issued on the last 15 of March, the UK ...
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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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