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Blog Category: Medical Device

Medical Device

Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates

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Medical Device

China – Notice on registration of medical device master files (No. 2 of 2021)

On March 5, 2021, the State Food and Drug Administration of China issued an announcement on the Registration of Medical Device Master Files. The relevant matters that facilitate the owner of the master...

FDA Medical Device clinical Regulations, Food and Drug Administration of China, medical device labeling requirements, medical device master files, medical device registration information system, Notice on registration of a medical device

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Medical Device

Medical Devices – Asia Regulatory Updates round up – Aug 2021

Philippines (FDA) 1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical...

2 of Permit to use of Medical Devices, ASEAN Harmonized Technical Requirements, Authorization for a Medical Device, CPAP and BiPAP devices, Guide MDMC Online System, License Applications of Medical Devices, medical device pertaining to Dental, Medical Device pertaining to Obstetrical and Gynecological, medical device pertaining to Pediatrics and Neonatology, medical device pertaining to Urology, Regulation of software based medical devices, Warning to advertisers about test kits

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