PERTH, Australia – As New Zealand and Australia prepare to open up their economies, regulators in these two neighboring countries take a very different approach to regulating COVID-19 devices with New Zealand limiting treatment tests at the point of care, while Australia is implementing more post-market activities strict.
The New Zealand Medical Devices and Medical Devices Safety Authority (Medsafe) announces that they will limit all COVID-19 (POC) treatment tests to not be imported, produced, or supplied in New Zealand, unless permitted by Medsafe. At present, there is no COVID-19 POC test authorized by Medsafe.
The Ministry of Health clarifies that any kit or other test material intended to be used as a POC test for COVID-19 infections or for post-infection confirmation using an antigen or antibody detection system is prohibited from importing, manufacturing, packaging, selling, supplying or using unless this test has been approved by the Group Manager, Medsafe or the Ministry of Health.
Another condition is that the POC test will only be used for testing by certain categories of registered health care professionals approved by the Group Manager, Medsafe or the Ministry of Health.
Penalties for violating restrictions include imprisonment of up to three months or a maximum fine of NZD $ 500 (US $ 306).
Device not rated
In-vitro medical and diagnostic devices in New Zealand are not assessed and approved by Medsafe before they can be given and used. Medsafe uses the market notification process for medical devices and does not conduct initial market appraisals or use approval notices; however, manufacturers must register their products in the Medsafe Web-Assisted Notification of Devices (WAND) database within 30 days after commercializing their products.
New Zealand Director General of Health Ashley Bloomfield said COVID-19’s testing and planning capability in the country “is up to the task of detecting and quickly containing this disease if it reappears when we reduce alertness levels.”
“Testing is an important part of New Zealand’s elimination strategy and is a major starting point for identifying and containing the spread of the virus,” Bloomfield said.
The Ministry’s testing plan aims to:
- Quickly identify all new cases of viruses to isolate them and track and quarantine their contacts;
- Ensure that testing is fairly accessible to all groups;
- Identification of undetectable community distribution in New Zealand; and
- Monitor COVID-19 in people at higher risk for exposure.
Local health councils propose updated plans on how they will continue to test not only people who fit the case definition, but also contact cases where the source of infection is unknown, and people without symptoms are at high risk of exposure. They will also ensure that 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 the New Zealand Institute of Environmental Science and Research on February 1, and the country has the capacity to carry out 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 around 4.8 million people.
“The positive rate of our tests is now under 1% – sitting at 0.85% and we continue 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 a walk in April.
He offered his resignation but Prime Minister Jacinda Adern did not accept it. However, he removed it from the portfolio of his colleague’s finance minister and lowered it to the bottom of the cabinet.
“Under normal conditions, I will fire the minister of health. “What he did was wrong, and there is no reason,” Ardern said in a statement.
“But now, my priority is our collective struggle against COVID-19. We cannot do massive disruption in the health sector or our response. For that reason, and that reason alone, Dr. Clark will maintain his role. “
TGA conducted a post-market review of COVID-19 facial masks
Meanwhile, across the Tasman Sea, the Australia Therapeutic Goods Administration (TGA) Australia is conducting a post-market review of facial masks included in the Australia Therapeutic Goods List (ARTG).
COVID-19 has increased the demand and supply of personal protective equipment such as face masks, and many of them have been produced and imported from abroad. Many concerns have been raised about the quality and effectiveness of some of these masks, including that they are included in ARTG but do not meet the requirements for medical devices. Other masks may not function as intended.
The TGA will conduct a post-market review to ensure that all masks registered with ARTG meet all requirements. Manufacturers must ensure that their products are listed on ARTG, and the TGA recommends that if a product is not listed, they must immediately withdraw it from the list.
The producer must also be prepared to have a certificate of conformity assessment; list of mask models, including inventory numbers by model and year and status in Australia; packaging and labeling documentation; instructions for use that are included with the product; and evidence from clinical trials or tests to support claims made about effectiveness.
TGA issued an exception for domestic producers
The TGA also issued emergency exemptions to allow domestic producers to make and supply ventilators during the COVID-19 pandemic. Exceptions apply to devices not registered with ARTG as long as the manufacturer can demonstrate compliance with minimum technical requirements.
The TGA clarifies that the exclusion does not permit the general supply of these ventilators to health care facilities or consumers outside the context of COVID-19 emergencies.
Ventilators supplied on the basis of an exemption must be made domestically in Australia, only supplied to Australian health care facilities, and meet the specifications and testing requirements published in guidance released in April.
After the release request is received, the TGA will issue a permit giving the manufacturer the right to supply ventilators to Australian hospitals.
New guidance including a risk assessment checklist, testing procedures, a statement that the device was manufactured in accordance, with minimum requirements, and instructions for using the checklist.
The TGA will publish a list of all ventilators that have been given permission to supply under the exception of the COVID-19 ventilator. Manufacturers who are granted an exemption will be subject to an ongoing obligation to report requirements for adverse events, recording and inspection and testing requirements.
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