Heath Canada is making changes to its Medical Devices Regulations with the aim of improving their ability to identify, assess and manage new risks for medical devices used in Canada. Read more “Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices”
Category: International
UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
From 01 January 2021, pharmaceutical companies that submit applications to some or all of the five countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times. Read more “UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium”
Implications for Medical Device Usability Engineering following amendments to IEC 62366
International Standard IEC 62366-1: Application of usability engineering to medical devices, was updated and published in June 2020. Read more “Implications for Medical Device Usability Engineering following amendments to IEC 62366”
New guidelines on the submission of periodic risk assessment reports to the NMPA
Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to the National Medical Products Administration (NMPA). Read more “New guidelines on the submission of periodic risk assessment reports to the NMPA”
Switzerland approves revision of the Medical Devices Ordinance (MedDO)
In a move towards harmonisation with the EU Medical Device Regulation (MDR), the Swiss Federal Council have approved a thorough revision of MedDO and the new Ordinance on clinical Trials for Medical Devices (ClinO-MD). Read more “Switzerland approves revision of the Medical Devices Ordinance (MedDO)”
Highlights from the June 2020 ICMRA meeting on COVID-19
At the International Coalition of Medicines Regulatory Authorities (ICMRA) regular virtual meeting, high-level policy issues and regulatory approaches to ensure a co-ordinated response to the ongoing pandemic were discussed. Read more “Highlights from the June 2020 ICMRA meeting on COVID-19”
South Korea adds renewal requirement for new medical device authorisations
South Korea’s Ministry of Food and Drug Safety (MFDS) have published revised guidance for medical device authorisations. Read more “South Korea adds renewal requirement for new medical device authorisations”
Expanding the availability of critical ventilator devices to fight COVID-19
With an urgent need for the rapid manufacture of life-saving ventilator systems for hospitals to fight the current pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA), along with their international counterparts, have outlined how they intend to expand the availability of such devices. Read more “Expanding the availability of critical ventilator devices to fight COVID-19”
The first in-human trial for a coronavirus vaccine!
The first dose of a potential coronavirus vaccine has been administered to a clinical trial participant in the US. Read more “The first in-human trial for a coronavirus vaccine!”
COVID-19: Asia-Pacific Regulatory roundup
Catch up with the latest COVID-19 related regulatory interventions in the Asia-Pacific region. Read more “COVID-19: Asia-Pacific Regulatory roundup”