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Regulatory Focus™ > News Articles > 2020 > 9 > Asia-Pacific Roundup: Face masks deregistered amid TGA postmarket review

Asia-Pacific Roundup: Face masks deregistered amid TGA postmarket review

Posted 08 September 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: Face masks deregistered amid TGA postmarket review

Almost 400 sponsors have pulled their face mask from the Australian Register of Therapeutic Goods (ARTG) amid a postmarket review undertaken by the Therapeutic Goods Administration (TGA) amid concerns that some recent listings triggered by COVID-19 fail to meet the legislative or performance requirements.
 
To date, 384 sponsors have voluntarily cancelled their ARTG listings. TGA noted that these devices have not been recalled as the agency has received no evidence in relation to their compliance with manufacturing standards or their performance. In a separate notice giving guidance to companies selling masks in Australia, TGA advised sponsors that realize they do not meet the regulatory requirements to cancel their ARTG inclusions.
 
An additional 12 masks were cancelled by TGA, mostly due to either the incorrect classification of a product or the discovery that the listed item is not a medical device. One mask, Imex Global Partners’ N95 respirator, was delisted “as a statement made in connection with the application was false or misleading in a material particular.” The manufacturer of the respirator is Chengde Technology.
 
In a linked notice, TGA asked companies that import or supply face masks to make sure they have a declaration of conformity from the manufacturer, a list of the masks they sell and the Australian states they operate it, and information about the production standards they follow.
 
TGA also emphasized the need for face masks to fit properly. The agency wants end users to “check facial fit to ensure the right respirator products have been issued and that they are wearing the respirators properly.”
 
TGA Notice, More
 
India’s CDSCO proposes risk classifications for hundreds of devices and IVDs
 
The Central Drugs Standard Control Organization (CDSCO) has proposed risk classes for hundreds of medical devices and in vitro diagnostics (IVDs) sold in India as part of an ongoing regulatory overhaul.
 
In February, the Indian government published legislation to bring all devices used in the diagnosis, prevention, monitoring, treatment or alleviation of diseases or disorders under the more stringent regulatory framework for drugs. The government said it would bring the law into force at the start of April 2020 but give the industry 18 months or more to comply with the requirements.
 
How long companies get depends, in part, on the risk classification assigned to their devices. CDSCO shared that key information in two documents, one for devices, another for IVDs, late last week.
 
The device document features 24 categories of medical devices, some of which contain more than 100 different products. For example, the anesthesiology category states that aerosol delivery tubing will fall into the low-risk Class A, while anesthesia machines will be placed in the higher-risk Class C. The regulatory exemption period for Class A and B devices differs from that of Class C and D products.
 
CDSCO, which provided risk groupings for IVDs in a separate document, has asked organizations and people affected by the proposals to share comments on the draft by around the end of the month.
 
Device Classification, IVD Classification
 
Malaysia’s MDA establishes requirements for conformity assessment bodies
 
Guidance from the Medical Device Authority (MDA) clarifies that conformity assessment bodies (CAB) should be managed by Malaysian citizens, have safeguards to ensure impartiality and employ auditors with relevant degrees and ISO training.
 
Malaysia began registering CABs to independently assess manufacturers, importers and distributors of medical devices after passing legislation covering the industry in 2012. The legislation required all medical device manufacturers to register their products and obtain establishment licenses, creating a need for independent assessors to serve a similar function to European Union notified bodies.
 
MDA emphasized impartiality and confidentiality. Neither a CAB nor its auditors can be “involved in the design, manufacture, construction, marketing, installation, servicing or supply of the medical device under assessment.” MDA also has placed restrictions on the role of CABs in the quality management systems they audit and consultancy activities.
 
Registrations awarded by MDA last three years. MDA has asked CABs to resubmit registration filings 12 months before their current paperwork is set to expire.
 
MDA Guidance
 
Philippine FDA imposes postmarket requirements on COVID-19 antigen tests
 
The Philippine Food and Drug Administration (FDA) has asked companies that sell COVID-19 antigen tests to provide 100 kits for postmarket evaluation.
 
Early in the pandemic, FDA began requiring companies that bring antibody tests to market via an emergency pathway to send their products to the Research Institute for Tropical Medicine for postmarket evaluation. The notice issued by FDA last week extends the requirement to cover the manufacturers of antigen tests designed to diagnose active infections with SARS-CoV-2.
 
Antigen testing has played a relatively small role in the management of the pandemic around the world to date, in large part due to the inaccuracy of early products. The development of fast, cheap and, according to manufacturers, more accurate tests by companies such as Abbott and Roche could see antigen kits play a bigger role in the next phase of the pandemic.
 
As of 17 August, FDA had approved less than 10 antigen tests. The list includes Quidel’s Sofia 2 SARS Antigen FIA, which was one of the first antigen products to show the approach could achieve similar levels of accuracy to polymerase chain reaction tests. 
 
FDA Notice
 
TGA sues two companies over alleged unlawful activities
 
TGA has begun court proceedings against two companies and their directors. The agency accused one company of unlawful advertising in relation to COVID-19, and the other of illegal activity involving performance-enhancing drugs.
 
Oxymed Australia received five infringement notices in March over its promotion of hyperbaric oxygen therapy chambers to treat COVID-19 and other disease. In disclosing the court proceedings, TGA said Oxymed Australia is yet to pay the AU$63,000 ($46,000) fine associated with the notices or remove the adverts from its website.
 
TGA also is pursuing legal action against online supplement seller HEALTHHUB247. The case covers 35 charges related to the alleged manufacture, counterfeit, supply and advertising of selective androgen receptor modulators and other performance-enhancing products. The maximum penalty is five years in prison and an AU$888,000 fine.
 
The likelihood that court proceedings will not ensure quick compliance means TGA favors infringement notices, according to recent guidance. The agency, however, will take companies to court if necessary.
 
TGA Notice, More
 

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