Asia-Pacific Roundup: TGA plans changes to assistive technology oversight

RoundupsRoundups | 28 July 2020 |  By 

Australia’s Therapeutic Goods Administration (TGA) is set to limit its definition of assistive technology to low-risk products to clarify which devices are subject to its oversight. TGA chose the revised definition despite a consultation revealing opposition to the change from some trade groups.
In September, TGA held a consultation to advance reforms proposed by the Expert Panel Review of Medicines and Medical Devices Regulation. The panel called for TGA to remove products from the auspices of the Therapeutic Goods Act if they could be regulated under other frameworks without undermining public health and safety. That led TGA to gather feedback on different ways of clarifying which devices designed for people with disabilities should be regulated as therapeutic goods. 
Based on that feedback, TGA plans to exempt from therapeutic goods regulation only “low-risk assistive technology.” Under the current scheme, Australia exempts “household and personal aids, or furniture and utensils for people with disabilities.”
Feedback on the consultation was not unanimous. Some respondents voiced support for limiting exemptions to “low-risk assistive technology.” However, other groups criticized that option and instead backed the creation of a list of specific products that are excluded from the regulation.
The Australian Orthotic Prosthetic Association (AOPA) told TGA the reliance on a revised definition, known in the consultation as option 1A and 1B, would create a “significant risk” for users of orthotic and prosthetic devices.
“Currently proactive regulation from the TGA ensures medical devices are safe and held to a basic standard. Under option 1A or 1B, assistive technology would be regulated by the ACCC/Fair trading model which does not have the necessary legislative authority and mechanisms that are required to effectively regulate medical devices,” AOPA wrote in its feedback.
Assistive Technology Suppliers Australia and Audiology Australia also spoke out against option 1A and 1B. However, even the critics of those options acknowledged the creation of a list of exempt devices could create problems, for example by imposing additional burdens on TGA and raising the risk that the agency will be unable to revise the list as quickly as new technologies emerge.
Such concerns led organizations including the Australian Rehabilitation and Assistive Technology Association and Occupational Therapy Australia  (OTA) to favor a revised definition over a list. OTA said limiting exemptions to low-risk technology would provide the required clarity and “a degree of capacity to deal with emerging technologies without further regulatory amendment.”
Faced with a divided industry, TGA spoke to the National Disability Insurance Agency and other groups. The talks led TGA to decide to exclude devices based on a definition, not a list. TGA is now working on guidance to clarify which devices will be excluded, potentially with a view to mitigating concerns about the potential to inadvertently change how hearing aids, prostheses and orthoses are regulated.
TGA Summary
India’s DGFT rejects all requests to export COVID-19 medical coveralls
India’s Directorate General of Foreign Trade (DGFT) has rejected all applications to export a limited number of medical coveralls. DGFT knocked back the submissions after finding none of them met its criteria.
Late last month, DGFT relaxed the prohibition on the exportation of personal protective equipment (PPE) that it imposed in response to COVID-19. The change cleared companies to apply for clearance to export up to 5 million medical coveralls a month. However, DGFT found all of the applications fell short of its requirements. (RELATED: Asia Regulatory Roundup: TGA ties fee increases to inflation, despite medtech opposition, Regulatory Focus 30 June 2020).
The shortcomings of the applications means DGFT is yet to clear any companies to export the PPE. DGFT is persisting with the quota system, though. Companies can again file for clearance to export coveralls and will be able to do so at the start of every month. Export licenses will last three months.
DGFT shared the update shortly before revising the list of PPE that cannot be exported. Under the new policy, DGFT will permit the export of surgical drapes, isolation aprons, surgical wraps and x-ray gowns. The export of other medical coveralls and different types of PPE remains prohibited.
Separately, DGFT created a pathway for companies that want to export PPE samples for testing or evaluation by potential buyers. Manufacturers of medical coveralls can now apply to export up to 50 medical coveralls per country.
DGFT Notice, More
Philippine FDA stops accepting emergency use filings for hydroxychloroquine
The Philippine Food and Drug Administration (FDA) has stopped accepting applications for clearance to use hydroxychloroquine in response to the COVID-19 emergency. FDA also removed chloroquine and the lopinavir-ritonavir combination from the list of products eligible for emergency use filings.
In April, FDA created drug products under emergency use (DEU) guidelines to help companies get potential COVID-19 treatments to patients. The guidelines supported DEU authorization of four drugs.
Last week, FDA removed three of the drugs from the list. The change follows the publication of data from multiple studies that found hydroxychloroquine and lopinavir-ritonavir are ineffective against COVID-19. The World Health Organization dropped the drugs from its Solidarity trial this month.
FDA’s action leaves tocilizumab, sold by Roche as Actemra, as the sole medicine covered by the DEU guidelines. Today, four forms of tocilizumab are eligible for the DEU pathway. FDA only accepted one form when it introduced the guidelines in March.
FDA Notice
Australia maintains medical device transition period despite delaying implementation
Australian officials have kept the 31 October 2024 end-date for the medical device reform transition period despite delaying the implementation of the requirements by six to 15 months.
With medical device companies shifting their attention to COVID-19, Australia proposed last month to follow the European Union in delaying regulatory reforms. The delays were confirmed last week, giving TGA more time to consult with the industry on guidance and details of the implementation.
In disclosing the delay, TGA said “it is important to note” Australia has retained the existing transition end date. As such, Australia, like the EU before it, has shortened the transition period it established to give companies time to comply with the new requirements.
The original transition period gave manufacturers more than four years to adapt. Under the revised implementation date, the transition period for some medical devices will be less than three years.
TGA Notice
Other News:
TGA has extended its serious shortage substitution notice for metformin modified-release 500 mg tablets until the end of the year. The extension empowers pharmacists to continue replacing the unavailable products with different metformin formulations. TGA may cancel the notice before the end of the year if supplies rise to a level needed to meet anticipated demand. TGA Notice
The Philippine FDA has revised its rules on the provision of COVID-19 test kits for validation. FDA is now asking manufacturers to provide it with 100 COVID-19 tests for evaluation, down from 300 when it introduced the requirement. Manufacturers that fail to provide tests may have their certifications revoked. FDA Notice
TGA has issued more fines in relation to COVID-19. Zafe Zone received a fine of AU$39,600 ($28,230) over alleged breaches of the rules on the promotion of disinfectants. Separately, TGA fined Strapit for claiming a Zafe Zone product killed COVID-19 without having the required authorizations. TGA Notice, More


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