Singapore Updates Guidance On Labeling, Essential Principles, Change Notification And Registration
Singapore has issued new guidance in four important areas of medical device regulation. The documents don't include mandates, but are intended as references for the industry and are subject to continual revision when appropriate.
You may also be interested in...
The Singapore Health Sciences Authority says regulatory changes that will provide faster market access for class A and many class B devices kicked in on June 1. The requirements for telehealth devices and high-risk devices cosmetic devices have also been clarified.
New medtech regulations in Singapore, a new medtech law in the Philippines, and another deferral of Act 737 in Malaysia were the focus of the Asian Medtech Associations Regulatory Networking discussions this month. In a break from the usual focus, there was also an update on the EU MDR and preparations for Brexit from the UK Association of HealthTech Industries (ABHI). This series is hosted by Medtech Insight and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), and the Asia Regulatory Professionals Association (ARPA).
Parliamentary debate next week on the post-Brexit regulatory adjustments ahead for the UK medical devices industry will coincide with the opening of post-Brexit EU trade talks by the UK government. After a period of nervous calm, Brexit will be back with a bang.