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”
Category: International
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”
A potential plasma-derived therapy for COVID-19
Development has been initiated for an anti-SARS-CoV-2 polyclonal hyper-immune globulin (H-IG) to treat high-risk individuals with COVID-19. Read more “A potential plasma-derived therapy for COVID-19”
Coronavirus-induced drug and device shortages
As the novel coronavirus outbreak continues to spread across the globe, Europe and the US are bracing for disruption to the medicine supply chain. Read more “Coronavirus-induced drug and device shortages”
FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic
The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US. Read more “FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic”