Guidance document for evaluation of medical device human factors/usability engineering Usability engineering has gained focus in recent...

Guidance document for Evaluation of Raw Material Changes in Passive Medical Devices Throughout the life cycle of a medical device,...

With increased surveillance on local e-commerce platforms and retail shops, over 1700 product listings have been removed for making false...

Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...

Australia: Updates to the definitions of medical device, accessory, instructions for use, user, and reusable surgical instrument...

Brazil: Market access process is simplified for Class II devices Brazil: Changes to conformity assessment requirements for certain single...

USA: FDA medical device user fees for fiscal year 2021 increase by about 7% USA: Proposed changes to regulations covering ‘intended use’...

EU: Common Specifications for the reprocessing of single-use devices EU: EUDAMED actor registration module to launch in December 2020 EU:...

The Medical Device Authority (MDA) in Malaysia has established a new Guidance Document to help healthcare professionals and the industry...

Instead of policy-based classification, Thailand is now moving towards a risk-based classification of medical devices for manufacturers...

Canada: Regulatory Enrolment Process (REP) pilot expanded to include private label applications and amendments Canada: Temporary rules...

Australia: New fees and charges took effect on 1 July 2020; reduced annual charges for devices on prostheses list Australia: Delayed...

EU: Notified Body designation renewal process to be eased temporarily EU: Guidelines on the adoption of Union-wide derogations for...

Brazil: Resolution RDC No 340 and Normative Instruction 61 cover changes to information both pre- and post-market Brazil: Changes to...

Canada: New fees came into force on 1 April 2020 USA: Ban on electrical stimulation devices used for self-injurious or aggressive...

Australia: Consultation on scope of regulated software-based products Bangladesh: New rules proposed for WEEE and RoHS that will affect...

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by...

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in...

The WCO reminds the general public to exercise extreme caution when purchasing critical medical supplies from unknown sources,...

The World Health Organization (WHO) supports the implementation of reliance on other regulators’ work as a general principle, making...