Category: Medical Device

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

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

EU Medical Device clinical Requirements, Europe Regulatory Updates, FDA Medical Device clinical Regulations, medical device labeling requirements, Medical Devices, Regulatory Updates, USA Regulatory Updates

Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

November 3, 2021
Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the PhilippinesThis Circular aims to: Specify the establishments classified as retailers...

Asia Regulatory Updates, Asia regulatory Updates round ups, China NMDA, India CDSCO, Japan FDA, Medical Devices, Philippines FDA, Regulatory Updates

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

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...

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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...

medicaldevice #regulatoryupdates #medicalquality #china #india #hongkongfda #philippinesfda #regulatoryintelligencesoftware #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