Catch up with the latest COVID-19 related regulatory interventions in the Asia-Pacific region.
The rapid extension of COVID-19 across the globe has led many regulatory bodies to take steps to ease import restrictions and accelerate registration processes for needed medicines and devices in the Asia-Pacific region.
In China, the Centre for Medical Device Evaluation (CMDE) announced adjustments to medical device application acceptance and consultation services. They have also published two new guidelines on nucleic acid and antigen/antibody detection reagents which could help to detect the coronavirus. Furthermore, they have published a guidance document on the registration of devices that can identify lung abnormalities caused by pneumonia, to evaluate infected individuals. As a temporary emergency measure, the Chinese National Medical Products Administration (NMPA) announced that medical protective clothing device registration will be expedited to align with the EU, US or Japanese standards.
Singapore’s Health Sciences Authority (HSA) have exempted specified devices such as surgical masks, thermometers and respirators from registration requirement, as well as exemptions for importers and wholesalers of those devices from establishing a license. A simplified notification route will be used to import such devices.
The Malaysian Medical Device Authority (MDA) has announced that companies will be allowed to apply for exemption from registration of face masks, with a view to safeguarding an adequate supply.
Australia’s Therapeutic Goods Administration (TGA) has issued an exemption for devices used for diagnosis, testing, prevention, monitoring and treatment of COVID-19. Devices relevant to the novel coronavirus will evade several registration requirements.
For detailed information on the Asia-Pacific regulatory response to COVID-19, click here.