Category: Medical Device
China – Notice on registration of medical device master files (No. 2 of 2021)
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
Medical Devices – Asia Regulatory Updates round up – Aug 2021
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
Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021
ANSM publishes a preventive management, distributors, FDA Conduct of Clinical Trials of Medical Products, FDA Export Certification, first certification for that type of device, generating devices under the Pest Control Products Act, Guidance for notified bodies, Medical Devices Regulatory Updates, MHRA shared guidance for manufacturers of devices, SARS-CoV-2 in vitro diagnostic medical devices
Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements
asean harmonized technical, authorization of medical devices, harmonization technical, Medical Devices
Regulatory Changes for Software Based Medical Devices in Australia
Medical device labelling requirements, regulatory guidance, Software as a Medical Device, Software Based Medical Devices in Australia, Therapeutic Goods Administration (TGA)
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