Canada: New Interim Orders are issued for importation and sale of medical devices for use in relation to COVID-19 and for reporting...

EU: Commission issues proposal for a regulation on a European approach for artificial intelligence EU: New and revised harmonised...

Australia: TGA’s proposed fees and charges for 2021–2022 Australia: TGA issues expectations for clinical performance requirements and...

Newsletter on medical products has been issued on ChinaDaily, on the new updates and information on medical devices, drugs, COVID-19 and...

HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection, to...

A new Medical Device Act was announced by the Taiwan Ministry of Health and welfare in November 2020 and has taken effect on 1 May 2021....

Ministry of Health (Vietnam) has published Circular No. 30/2020 in December 2020 to provide the industry a list of medical equipment that...

Ministry of Health (Vietnam) has released a draft decree that would replace Decree No. 36/2016/ND-CP and its revisions. This established...

On 20 November 2020, the new Medical Device Pricing Portal was opened to public, with the aim to achieve international standards on...

US FDA has released medical device guidance on COVID-19 related devices and topics to address the COVID-19 public health emergency. These...

IVDs subject to new performance evaluation studies in the UK must be registered by the time the study commences (no grace period). For...

July 08, 2021 The Thai FDA has announced new regulations for medical device registration on 15 February 2021. These new regulations are...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation...

On 5 November 2020, Taiwan announced a draft regulation for their Unique Device Identifier (UDI) Requirements for Medical Device Labels....

Switzerland’s Federal Office of Public Health (FOPH) has announced that on 14 April 2021, the Federal Council opened a consultation on...

The sales of hand sanitizers in Singapore do not require approval from Health Sciences Authority (HSA). From 31 Jan 2020, importer’s...

Extension for acceptance under GHTF route applications Submissions of MDMA (Medical Device Marketing Authorization) applications that...

Initial implementation In 2018, the Philippines FDA has released an Administrative Order 2018-0002 to provide guidelines on the...

The FDA has issued a circular No.2020-035 on 19 November 2020 regarding the Interim guidelines for the conduct of Licensing Inspection...

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