DMEC had a meeting with Vietnam MOH where the 1 year extension of new decree implementation has been approved. The medical device in the...

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...

EU: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal...

US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) US: Manual of Policies and Procedures(MAPP) 6021.1...

THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

Click here for the announcement.

According to an established EU notified body, there will be an extended timeline for the MEDDEV 2.7/1 Rev. 4. On May 5, 2017, the new...

HSA has announced the implementation of the Class A Medical Device Register for public access on 10 August 2017.This register allows...

Executive Summary: China is Making Additions to its medtech regulatory system, and Southeast Asian nations are making progress towards...

Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...

Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations Europe: Court of Justice delivers its...

Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...

Brazil: Medical device and IVD fee reductions formally take effect Brazil: Appeal timeframes extended by ANVISA Brazil: Mercury to be...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Executive Summary: All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller...

Executive Summary: Regulatory and Market Access Improvements for medtech products were on the agenda at last month's Health Products...

The proposal of regulation on medical devices used in the beauty trade has been submitted by the Department of Health (DoH) to Hong...

To drive the Singapore Committee on the Future Economy (CFE), HSA will be putting in place the following: Singapore Pre-market...

Executive Summary: Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and...

The US Food and Drug Administration (FDA) still plans to increase oversight of laboratory-developed tests (LDTs), despite an announcement...