The Health Sciences Authority (HSA) has shared their findings on a set of cybersecurity vulnerabilities known as "BrakTooth" that was...

Vietnamese Ministry of Health has published a new Circular 13/2021/TT-BYT on 16 September 2021. This circular provided an expedited...

July 08, 2021 The Thai FDA has introduced a Regulatory Reliance Program in Thailand where Class D (Class 4 in Thailand) medical devices...

MDA has announced that Circular Letter No. 1/2014 has been revoked effective 17 June 2021 in accordance with the decision made in the MDA...

Medical Device Authority (Malaysia) has published a guidance document on Personal Protective Equipment (PPE) requirements to help the...

The secretary of Health and Human Services (HHS) announced that conditions exist in justifying the provision of emergency use of the...

US FDA has published the finalised Labelling requirements guidance which assists labelers and FDA-accredited issuing agencies in...

Medical devices exempted from QMS certification requirements Taiwan Food and Drug Administration (TFDA) released the final list of...

The Ministry of Food and Drug Safety (MFDS) plans to make multiple amendments to the country's Medical Device Act during 2022 and expand...

An updated version of Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices and supplies,...

A revised version of Guidance on Requirements for Storage, Handling and Transportation of medical Devices: MDS-G25 has been published....

Philippines has issued an Administrative Order 2021-0038 in June 2021 with the purpose of establishing a standardised system for defining...

Medical Device Authority (Malaysia) has published a Conditional Approval for Covid-19 Rapid Test Kit (Self-test) guideline in July 2021...

Official European Commission journal has published the Medical Device Regulation 2017/745 (MDR) in 2017 and was planned to be enforced in...

The European In Vitro Diagnostic Regulation (IVDR) will be enforced in May 2022. Once it takes into effect, a Notified Body will be...

In March 2021, China has announced revision of Regulations on the Supervision and Administration of Medical Devices (State Council Order...

ANVISA, the Brazilian medical device market regulator, has released a proposed framework for Unique Device Identification (UDI)...

Australia TGA has announced that in early 2021, the new regulations for software-based medical devices went into force, resulting in a...

TGA Presents Conformity Assessment Bodies In July 2021, the Australian government agreed to regulatory amendments that will allow other...

Argentina: Further extension of exceptions for imported masks, gloves and IR thermometers Argentina: Extension of provisional...