Mar 10, 2020
The alarming worldwide diffusion of COVID-19 has inspired numerous governments to intervene to counter the spread of the disease. For their part, regulatory bodies that govern medical devices have taken steps to ease import restrictions and expedite registration processes for needed goods, seeking to ensure that regulations do not block the development or supply of devices that could save lives. What follows is a roundup of regulatory updates from the Asia-Pacific region pertaining to the outbreak.
The Singapore Health Sciences Authority (HSA) issued the Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020 on January 31. The Order exempts specified devices (particulate respirators, protective gear, surgical masks, and thermometers for measuring human body temperature) from registration requirements, and it exempts importers and wholesalers of those devices from establishment licensing requirements.
During the time when the Exemption Order is in effect, the named devices can be imported for commercial (or other non-personal) purposes through a simplified notification route, which is outlined on the HSA website.
In order to safeguard an adequate supply of face masks, the Malaysian Medical Device Authority (MDA) announced that companies can apply for exemption from registration for these devices through a Notification of Medical Device for Special Access. Devices that have obtained this exemption are not permitted to be advertised.
Australia’s Therapeutic Goods Administration (TGA) issued the Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020 on January 31 for devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of the novel coronavirus infection. The exemption is available for those devices imported, exported, manufactured, or supplied by a laboratory that is a member of the Public Health Laboratory Network. Devices supplied for purposes relevant to the public health threat posed by the COVID-19 emergency will circumvent several registration requirements, including the Essential Principles, conformity assessment procedures, and inclusion in the Australian Register of Therapeutic Goods (ARTG).
In order to avoid shortages, the Thai Food and Drug Administration (FDA) announced on March 11 that it would remove alcohol-containing gel products such as hand sanitizers from the category of regulated medical devices. These products were formerly regulated as cosmetic goods and will be legally defined as such again. This step will allow such products to reach the public considerably faster.
SAR guidance for medical devices not yet registered with Singaporean regulators
Malaysian regulators provide updates on device re-registration, post-market surveillance and other issues
Additional details on China’s new electronic registration system
Back in 2012 and 2013, Emergo and other medical device industry news sources began reporting on an effort by the Association of Southeast Asian Nations (ASEAN) trade bloc to establish harmonized device registration systems across 10 countries in the region.