Temporary regulatory measures for medical supplies and diagnostic tests in China and Australia
While countries around the world grapple with containment of the COVID-19 virus, a number of governments have implemented or are considering implementing special measures. Some of these temporary measures present companies that produce medical supplies with new opportunities to fast-track delivery of such supplies to virus affected countries. One such example is the recent introduction in China of regulatory exemptions for the importation of certain medical devices, including protective medical equipment.
The sale and use of medical devices in China, including any imported medical devices, are generally subject to stringent regulations. These include the requirement that medical devices imported into China must either be registered in accordance with regulations under Chinese law, or be certified by the National Medical Product Administration (NMPA).
In late January 2020, to assist in the containment efforts in relation to COVID-19, the NMPA issued the Notice of Importing Non-NMPA Approved Medical Devices which provides for medical devices to be urgently imported into China from overseas if the medical device has existing approvals in the United States, Japan or the EU.
Additionally, the Chinese task force for the guarantee of medical materials for COVID-19 issued a Notice on Issues related to the Importation of Protective Clothing, which expressly provides that medical protective clothing complying with Japanese, United States or EU standards may be urgently imported into China.
In line with the exemptions under these Notices, importers of medical devices and medical protective clothing must provide evidence of the relevant foreign certification and test reports, as well as providing appropriate commitments as to the quality and safety of the imported products. Provided these requirements are met, certain imported medical devices and medical protective clothing do not otherwise have to comply with the usual NMPA regulatory requirements.
Under the terms of the NMPA Notices, these emergency measures will only have effect during the period of epidemic prevention and control and will be cancelled thereafter. A number of other temporary regulatory measures or exemptions have been put in place both at National and Provincial level in China to facilitate the delivery of medical supplies to those who need them. Some of these are uncertain in scope and duration, so companies should be cautious about the status of exemptions, including those that apply specifically to the particular geographic destination for their products (such as Provincial level measures in China).
Press reports indicate that the Australian company, Ansell, has been able to play a major role in supplying personal protective equipment (PPE) in China since the start of 2020. Due to the surge in demand for PPE in China, the Australian company has worked with Chinese authorities to ensure production rates of protective body suits in its factory in China could be increased to meet the temporary demand. The company was also able to fast-track importation of rubber gloves and masks to China from its production facilities outside China.
In Australia the Therapeutic Goods Administration (which registers medical devices for use in Australia) has released the Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020, which exempts certain types of medical devices (principally diagnostic tests used in laboratories) from specified TGA requirements in Australia. This emergency provision will remain in place until January 2021 and aims to enable diagnostic tests to be more readily accessible on an urgent basis in response to assist in combatting the spread of the COVID-19 virus.
Temporary regulatory measures such as these highlight the potential business opportunities for companies who produce medical supplies or diagnostic tests and who may wish to direct their efforts to countries which are focused on COVID-19 virus containment measures. Countries including China and Australia are focussed on ensuring that products and other medical assistance are urgently made available to those on the front line dealing with patients who have contracted the virus in order to enable containment efforts.
Because both the spread of the virus and regulatory changes are fast moving, companies also need to ensure they have up to date information on regulatory requirements and exemptions, to ensure they can take advantage of temporary measures but also that they are not tripped up by sudden changes to regulations.