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.
Chinese regulatory bodies roll out numerous emergency regulatory changes
- The National Medical Products Administration (NMPA) announced that they will expedite the registration of medical protective clothing devices that meet relevant standards from the EU, US, or Japan, as well as the Chinese standard GB 19082-2009 (Technical Requirements for Single-Use Protective Clothing for Medical Use), as a temporary emergency measure.
- The Center for Medical Device Evaluation (CMDE) announced adjustments to their medical device application acceptance and consultation services, beginning on February 3. The CMDE encourages the use of their online eRPS system and will temporarily suspend on-site acceptance of applications and consultation services.
- The CMDE published two new technical review guidelines on nucleic acid detection reagents and antigen/antibody detection reagents designed for IVDs that will detect coronavirus.
- The CMDE announced extensions for renewals and data correction requests due to delays caused by the COVID-19 outbreak. Extensions for renewal applications can now be filed within three months of the date the outbreak dissipates. Applications that have been notified to submit additional technical reviews or data corrections from February 12, 2019 to the end of the outbreak will be given an additional year to submit the information.
- The CMDE published a guidance document on registering devices that use deep learning technology to identify lung abnormalities caused by pneumonia based on CT images of the lungs to evaluate people infected with coronavirus. The guidance specifies the basic requirements, as well as the requirements for risk management, software research materials, clinical trials, instructions, and software updates for these devices.
- Due to a shortage of medical masks in Hubei province, the provincial NMPA office will allow importation of unregistered masks as an emergency measure. While the measure is in effect, only an import authorization is needed for qualifying products. Manufacturers will need to work with licensed distributors in Hubei in order to import under this allowance.
Singapore names devices temporarily exempt from registration requirements
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.
Malaysia provides application for face mask registration exemption
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 provides registration exemption for specified goods from authorized laboratories
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).
Thailand reclassifies alcohol-containing gel products as cosmetic goods
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.
Related resources for medical device regulation in the Asia-Pacific region:
- China NMPA medical device registration and approval consulting
- Australian TGA medical device registration consulting
- Singapore HSA medical device registration and approval consulting
- Malaysia MDA medical device registration and approval consulting
- Customized regulatory pathways for smaller markets
- Process chart: Australian TGA regulatory approval process
- Process chart: Singapore medical device regulatory pathway
- Process chart: China NMPA regulatory approval for medical devices
- Process chart: Malaysia MDA device registration pathway
- Whitepaper: China NMPA medical device registration
- Webinar: Medical device registration in China