Asia Pacific Regulators Expedite Registrations in Response to COVID-19 Shortages

Regulatory agencies in Asia have rolled out multiple emergency measures for medical devices and diagnostics to help respond to the COVID-19 outbreak.

China’s National Medical Products Administration said it will expedite registration of medical protective gear that meets standards in the EU, U.S., Japan and China.

In addition, China’s CDME released guidance on devices that use artificial intelligence to identify pneumonia based on computed tomography images to better evaluate patients infected with COVID-19.

Singapore’s Health Sciences authority has exempted registration requirements for some devices that are experiencing shortages, including respirators, protective gear, surgical masks and thermometers. While the exemption applies, devicemakers can import the devices through a simplified notification route.

India’s Central Drugs Standard Control Organization (CDSCO) has opened up a new fast-track process to encourage in vitro diagnostics makers to develop IVDs to diagnose COVID-19.

CDSCO said that any firm with an IVD under development for COVID-19 can ask for priority clearance. Companies that have IVD test kits approved in other countries can also get expedited approval to market their devices in India.

CDSCO said that data requirements for clinical performance evaluations may be abbreviated, deferred or even waived on a case-by-case basis, depending on the nature of the diagnostic kit. Applications to manufacture or import IVD kits for COVID-19 could be processed within seven days.

Australia, Malaysia and Thailand have all instituted similar exemptions.