PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) announced that it will restrict all COVID-19 point of care tests (POC) from being imported, manufactured or supplied in New Zealand, unless they are authorized by Medsafe. Currently, there are no COVID-19 POC tests authorized by Medsafe.
The Health Ministry clarified that any kits or other test materials intended for use as POC testing for COVID-19 infection or for post-infection confirmation using an antigen or antibody detection system is prohibited from importation, manufacture, packing, sale, supply or use unless the test has been either approved by the Group Manager, Medsafe or the Ministry of Health.
The other condition is that POC tests are only to be used for testing by a specified category of registered health care professionals approved by the Group Manager, Medsafe or the Ministry of Health.
The penalty for breaching the restrictions include imprisonment for up to three months or a maximum fine of NZD$500 (US$306).
Devices not assessed
Medical devices and in vitro diagnostics in New Zealand are not assessed and approved by Medsafe before they can be supplied and used. Medsafe uses a market notification process for medical devices and doesn’t conduct a premarket assessment or use an approval notice; however, manufacturers must list their products in Medsafe’s Web-Assisted Notification of Devices (WAND) database within 30 days of commercializing their product.
New Zealand’s Director-General of Health Ashley Bloomfield said the country’s COVID-19 testing capability and planning is “up to the task of detecting and quickly containing the disease if it re-emerges when we move down alert levels.”
“Testing is an essential part of New Zealand’s elimination strategy and is the key starting point for identifying and containing the spread of the virus,” Bloomfield says.
The Ministry’s testing plan aims to:
District health boards are submitting updated plans on how they will continue to test not only people who fit the case definition, but also contacts of cases where the source of infection is unknown, and asymptomatic people at high risk of exposure. They will also ensure all cases and contacts in high-risk settings are tested and isolated or quarantined to prevent further spread of the virus.
The first COVID-19 test was completed in New Zealand by New Zealand’s Institute of Environmental Science and Research on Feb. 1, and the country has the capacity to perform up to 12,535 tests per day, Bloomfield said. Already, more than 175,000 tests have been completed in New Zealand, which has a population of about 4.8 million people.
“Our testing positivity rate is now below 1% – sitting at 0.85% and we’re continuing to test widely,” he said.
New Zealand Health Minister David Clark was demoted after he ignored national lockdown rules and took his family to the beach for an outing in April.
He offered his resignation but Prime Minister Jacinda Adern did not accept it. She did, however, strip him of his associate finance minister portfolio and demoted him to the bottom of the cabinet rankings.
“Under normal conditions, I would sack the minister of health. What he did was wrong, and there are no excuses,” Ardern said in a statement.
“But right now, my priority is our collective fight against COVID-19. We cannot afford massive disruption in the health sector or to our response. For that reason, and that reason alone, Dr. Clark will maintain his role.”
TGA conducts postmarket review of COVID-19 face masks
Meanwhile, across the Tasman sea, Australia’s Therapeutic Goods Administration (TGA) is conducting a postmarket review of face masks that are included in the Australian Register of Therapeutic Goods (ARTG).
COVID-19 has increased the demand and supply of personal protective equipment such as face masks, and many of these have been manufactured and imported from overseas. Numerous concerns have been raised about the quality and effectiveness of some of these masks, including that they are included on the ARTG but don’t meet the requirements for medical devices. Other masks may not perform as intended.
The TGA will conduct a postmarket review to ensure that all masks listed in the ARTG meet all requirements. Manufacturers should ensure that their products are listed on the ARTG, and TGA advises that if products are not listed, they should immediately withdraw them from the listing.
Manufacturers should also be prepared to have documentation of a conformity assessment certificate; a list of models of masks, including supply numbers by model and year and the status within Australia; documentation of packaging and labeling; instructions for use supplied with the product; and evidence from a clinical trial or testing to support any claims made on effectiveness.
TGA issues exemption for domestic manufacturers
The TGA also issued an emergency exemption to allow domestic manufacturers to make and supply ventilators during the COVID-19 pandemic. The exemption applies to devices not listed on the ARTG as long as the manufacturer can demonstrate compliance with minimum technical requirements.
The TGA clarified that the exemption does not permit the general supply of these ventilators to health care facilities or consumers outside the context of the COVID-19 emergency.
Ventilators supplied under the exemption must be manufactured domestically in Australia, only be supplied to Australian health care facilities, and meet the specification and testing requirements published in guidance released in April.
Once applications for exemption are received, the TGA will issue permissions granting manufacturers the right to supply the ventilators to Australian hospitals.
New guidance includes a risk assessment checklist, test procedures, a declaration that the device is manufactured according, to the minimum requirements, and an instructions for use checklist.
The TGA will publish a list of all ventilators it has granted permission to supply under the COVID-19 ventilator exemption. Manufacturers that are granted the exemption will be subject to ongoing obligations for reporting requirements for adverse events, recordkeeping and inspection and testing requirements.