Hong Kong
Currently, there is no specific legislative control over the manufacture, importation, sale supply and use of medical devices, including Covid-19 Rapid Antigen Test (RAT), in Hong Kong. A voluntary Medical Device Administrative Control System has been established by the Department of Health (DH) to raise public awareness of the importance of medical device safety and pave the way for implementing the long-term statutory control. Listing of RAT is part of the system. RAT is a medical device belonging to Class C In Vitro Diagnostic Medical Devices (IVDMD).
Listed Rapid Antigen Tests for COVID-19 under the Medical Device Administrative Control System can be found here:
https://www.mdd.gov.hk/en/whats-new/rapid-antigen-tests-covid-19/index.html
Besides, on the RAT page in the COVID-19 Thematic Website, there is a list of RAT kits distributed for free to specified groups by the Government. For details, please visit https://www.coronavirus.gov.hk/rat/eng/rat.html
Mainland China
With reference to the Provisions for In-Vitro Diagnostic Reagent Registration, as such RAT products are “reagents related to the testing of antigen for pathogen”, they are Class III In-Vitro Diagnostic Reagent and required to be registered. They shall be reviewed by National Medical Products Administration, and the medical device registration certificate shall be issued after approval. For an in-vitro diagnostic reagent which is urgently needed in dealing with emergent public health incidents but no equivalent products on the market, or there are equivalent products on the market but the supply could not meet the demand during emergent public health incidents, then emergency registration may be granted for in-vitro diagnostic reagents.
List: https://www.nmpa.gov.cn/yaowen/ypjgyw/20221230202032116.html
Consumers should read the product name and information carefully to ensure that products of the correct type are purchased.
European Union
Manufacturer
The EU common list of COVID-19 rapid antigen test shows "name of submitting company" which is identical to what is included in the Instructions For Use (IFU) and/or labelling of the rapid antigen test. If the company is the manufacturer, it is mentioned after the company name.
EU-A
COVID-19 rapid antigen tests evaluated by prospective clinical field studies.
EU-B
COVID-19 rapid antigen tests evaluated by retrospective in vitro studies.
United States
In normal circumstances, before a medical device is put on the market of the United States, it needs to go through the processes of pre-market notification 510(k) or pre-market approval (PMA) by submitting documents enough to substantiate its safety and effectiveness.
On February 4, 2020, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act, the United States started to issue Emergency Use Authorization (EUA) for use of different medical products for diagnosing and treating patients of COVID-19. The issuance of EUA is based on the belief that potential benefits of using the product outweigh the potential risks and that the product "may be effective", which is different from that of 510(k) or PMA.
The list includes different types of products. Products for self-testing are required to declare “Over the Counter (OTC) Home Testing”. Consumer should pay heed to ensure that the correct product is purchased.
Australia
Since 1 November 2021, the Therapeutic Goods Administration (TGA) of Australia has approved a list of COVID-19 rapid antigen self-tests (home use tests) for supply in Australia.
The list https://www.tga.gov.au/covid-19-rapid-antigen-self-tests-are-approved-australia
To be accepted by TGA COVID-19 rapid antigen self-tests need to have:
- a clinical sensitivity of at least 80% (for specimens collected within 7 days of symptom onset)
- a clinical specificity of at least 98%.
According to the positive percent agreement (PPA) obtained by studies performed by the manufacturer, a comment on the clinical sensitivity is given by TGA to each test as follows:
- Acceptable sensitivity - clinical sensitivity > 80% PPA
- High sensitivity - clinical sensitivity > 90% PPA
- Very high sensitivity - clinical sensitivity > 95% PPA
All approved tests meet TGA’s performance requirements. The inclusion of such comments on sensitivity does not represent TGA endorsement of a particular test.
There is a post-market review of RAT to determine whether they have been impacted by the current known variants of SARS-CoV-2, with ongoing activity to assess their ability to detect emerging variants, including laboratory testing to validate their performance in detecting the Delta and Omicron variants (and other emerging variants of concern).
Singapore
A list of COVID-19 self-tests have been authorized by the Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR). PSAR is an interim authorization to supply an "emergency medical device" under regulation 13C of the Health Products (Medical Devices) Regulations. A medical device meets the criteria for designation as an "emergency medical device" if it is required to treat or diagnose an infectious disease or any medical condition associated with an infectious disease that is likely to be serious or life-threatening.
Before approving products under PSAR, HSA evaluates rapid antigen self-test products based on data accumulated by companies to determine whether they meet relevant standards for safety, quality and efficacy.
The list: https://www.hsa.gov.sg/consumer-safety/articles/covid19_selftests
These products are for self-testing by consumers and do not require a doctor's prescription to purchase.
After PSAR approval, companies still need to collect data on accuracy and safety, and monitor product usage. After product approval, the HSA will request additional data from ongoing clinical studies to ensure the continued safety and efficacy of these PSAR-approved test products. If a safety or performance issue is identified, HSA will ask the company to take appropriate follow-up action.
Please note that manufacturer information is not shown in the list of Singapore.
Macau
The Pharmaceutical Administration Bureau (ISAF) of Macau announced on 16 March 2022 that according to Foreign Trade Law as Covid-19 Rapid Antigen Test Kits are diagnostic and laboratory reagents, traders must first obtain the relevant prior authorisation for import from the Bureau before importing such test kits into Macau.
Importers are required to submit to the Bureau documents that can prove that their test kits meet the National Standards, have been certified according to EU requirements, have been approved for marketing by authorities in country of origin or country of export or are on the list of exported epidemic prevention and control supplies by the Ministry of Commerce. The test kits must have the required qualities (sensitivity and specificity) for diagnosis and be able to produce accurate test results before being put on the market.
The list: https://www.isaf.gov.mo/wp-content/uploads/2022/04/2022-covid-test.pdf