TGA announced change of regulations for Software including Software as a Medical Device (SaMD). and Personalised/Customised Device...

Requirements of the MDR/IVDR The MDR/IVDR clearly state that all manufacturers need to have a quality management system in place so as to...

The HPRA is continuing to work with the European Commission and other Member States in relation to medical devices issues arising from...

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions...

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve...

·U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a...

The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification...

Executive summary Medtech industry representatives from Thailand, Myanmar, Indonesia, Singapore and the Philippines gave updates on...

The Medical Device Authority (MDA) of Malaysia published a new circular letter regarding a transition period for companies to comply with...

European Union (EU) is one of HSA’s five reference regulatory agencies commonly referenced in abridged evaluation route for medical...

US FDA medical device cybersecurity guidance To sell in the US, there are two essential FDA medical device software cybersecurity...

The Ministry of Health and Welfare in Taiwan has released the advanced draft "Guidelines for Good Transportation and Marketing of Medical...

CDSCO has extended the deadlines for a list of medical devices that need to undergo registration for market authorization. This...

PART 1: Making UDI available on MDs in Singapore • Aligned to internationally harmonized principles outlined in the UDI guidance...

Japan MHLW implemented "Sakigake Shinsa Scheme", also known as the Fast-track Medical Device Approval Scheme. With this scheme in place,...

Thai FDA had come up with a set of advertising specification for medical devices that are exempted from obtaining a medical device...

Surgical Mask: Alongside with the set of COVID-19 related medical device announcement, FDA had announced a list of standards to be...

Singapore's medical device market is projected to register a compound annual growth rate (CAGR) of 8.4 per cent from 2018 to 2023, down...

Two important announcements were made by Chinese authority regarding regulation of medical devices 1.China NMPA has announced in...

The National Medical Products Administration (NMPA) has announced in Article 11, item 2, Decree 68 that it will pilot a program to allow...