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ICH Guideline E8 (R1) on General Considerations for Clinical Studies

October 21, 2021
Standards

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those...

Center for Drug Evaluation and Research, Clinical studies of medical interventions, ich e8 general considerations for clinical studies, ich e8 guidelines

Switch of the legal status of a medicinal product from prescription to non-prescription – Romania

October 18, 2021
Medical Device

Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription to non-prescription – Romania Principles and procedures: • It is to the applicant to...

Medical product, Prescription to non-prescription, principles for a switch of the legal status, switch of the legal status

Registration of Drug-device Combination Products

October 8, 2021
Standards

NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products With the view to strengthening registration management of drug-device combination products, in accordance with...

combinationproduct, drug, medicaldevice, NMPA, registrationofdrug, registrationondevice

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

October 6, 2021
Medical Device

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

Medical Devices-Asia Regulatory Updates round up-Sep 2021

October 6, 2021
Medical Device

China (NMDA) 1. 2th China International Medical Device Regulatory Forum held in WuhanSponsored by the China Center for Food and Drug International Exchange (CCFDIE), the 12th China International...

China, hongkong fda, india, Medical quality, medicaldevice, Philippines FDA, Regulatory intelligence software, Regulatory Updates, vistaar

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

September 30, 2021
Medical Device

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