After three years, China announced its reopening from January 8, 2023. Passengers can enter China without quarantine. All you need is a negative PCR result within 48 hours before departure. You do not need to apply for a health code. ... Read More >

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done.... Read More >

Consumer advocates say the proposed legislation has too many exemptions, while industry groups seek to limit premarket review requirements for legacy tests. ... Read More >

On February 21, the Notification on Regulating the Adjustment of Some Medical Service Prices, which included 16 assisted reproductive technologies such as artificial insemination and embryo transfer into Beijing medical insurance, was issued. ... Read More >

The European Union’s In Vitro Diagnostics Regulation (IVDR) is set to take effect May 26, 2022, but a recent effort to amend the transitional provisions of the new regulation may bring some relief.... Read More >

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report.... Read More >

The US Food and Drug Administration on Monday released revised guidance on its regulatory priorities and policies for COVID-19 tests. Read More >

The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics for products that still need assessment of a notified body. ... Read More >

FDA brought medtech up to speed on several key medical device programs during the CDRH Townhall at The MedTech Conference. Read More >

Companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking.... Read More >