Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines

| 28 June 2022 | By Nick Paul Taylor 

Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulatory frameworks launched in February 2021.
The PMD special topic describes the nature and type of clinical evidence that is needed to show the performance and safety of the devices, which are personalized for individual patients using technology such as 3D printing. In the new section, TGA explains PMDs, in general, will have the same regulatory requirements as non-PMD devices of the same classification.
“A legitimate and reasoned approach to clinical data generation, alongside a critical analysis regarding its limitations, will be viewed more favorably than a paucity or absence of clinical data. Whilst post market clinical follow up studies and real-world data may form a significant element of a manufacturer’s strategy for generating clinical evidence throughout the device lifecycle, especially in relation to addressing residual risks, they do not lessen the need for well-designed clinical investigation studies for pre-market approval of higher risk devices,” the guidance states.
TGA sees the Total Product Life Cycle approach as particularly important for PMDs “given the unique aspects of their design,” leading it to recommend that the clinical evidence is reviewed and updated “periodically” throughout the lifecycle of the device “to ensure continued acceptability of the benefit-risk determination.” The rest of the section sets out specific considerations for the three types of PMD: patient-matched medical devices, adaptable medical devices and custom-made medical devices.
The new chapter on SaMD is much shorter, occupying half a page of the guidance. TGA used the chapter to introduce SaMD, explaining that “clinical benefit may be considered slightly differently from that for pharmaceuticals or other medical devices.” For SaMD, the clinical benefit “most commonly lies in obtaining or collating clinical information which assists with clinical decision making,” the guidance states. If software makes a clinical benefit claim, safety, effectiveness and performance data are needed.
Rather than provide its own recommendations for SaMD evaluation, TGA linked out to documents from the International Medical Device Regulators Forum (IMDRF) and the European Commission’s Medical Device Coordination Group (MDCG) document. The linked documents cover the clinical evaluation of SaMD.
TGA also used the revision of the guidelines to update existing sections on essential principles and total and partial joint prostheses.
TGA Guidelines
TGA fines Hough Pharma $74,000 as COVID rapid antigen test validation push advances
TGA has fined Hough Pharma AU$106,560 ($74,000) for allegedly failing to provide information to show the safety and performance of three COVID-19 rapid antigen tests (RATs). The agency disclosed the fine on the same day as it shared an update on its postmarket review of laboratory and rapid antigen tests.
According to TGA, Hough failed to meet the deadlines for providing information on its RATs. Hough’s alleged failure to meet the deadline contributed to TGA’s conclusion that the company committed “serial non-compliance.”
TGA also received reports from consumers that Hough lacked customer support. After verifying the reports, the agency included the alleged failing in the charge sheet against Hough. TGA requires sponsors of self-test RATs to have a telephone or online helpline available seven days per week.
The agency disclosed the actions against Hough, which it called “a reminder to companies to take their obligations seriously,” on the same day as it provided an update on its postmarket review of antigen and rapid antigen tests. TGA is conducting the review to determine if tests work against variants and has asked manufacturers to provide study data to validate the performance of their kits.
In an update on its review, TGA revealed which variants are covered by the clinical and analytical data filed by manufacturers. The table, which lists 97 tests, including four sponsored by Hough, also features information about TGA’s validation of analytical sensitivity. The agency has confirmed that five tests comply with the World Health Organization’s limit of detection guidelines for the wild type, Delta and Omicron variants of SARS-CoV-2.
TGA Notice, More
New Zealand’s Medsafe finalizes warning for stimulant laxatives, sets 2024 deadline
New Zealand’s Medical Devices Safety Authority (Medsafe) has eliminated a warning statement that prolonged use of stimulant laxatives can be harmful, in response to feedback obtained via consultation.
Medsafe held a consultation last year as part of a push to minimize the misuse of stimulant laxatives. An anonymous professional body asked the agency to remove the word “prolonged” because “some patients may be taking the medicine on a regular basis for a specific clinical condition under the care of a health professional.” The agency has also changed the statement “consult a healthcare professional if symptoms persist” to “if symptoms persist seek medical advice.”
New Zealand will update its Label Statements Database on 1 September. Typically, Medsafe would give manufacturers 12 months to comply. However, in response to industry feedback, the agency has adopted an 18-month transition period.
Medsafe Notice
Malaysia’s NPRA updates eligibility conditions for conditional registration during disasters
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated the eligibility conditions for the conditional registration of pharmaceutical products during disasters with immediate effect.
The revised section previously said conditional registration was permitted if “existing products have not been successful in eradicating the disease or preventing outbreaks.” NPRA has retained that text but also added a more detailed breakdown of the product characteristics it will consider.
The document states conditional registration is open to products with new active ingredients, different mechanisms of action and vaccine platforms not previously registered in Malaysia, either conditionally or fully. In addition, the product should have as good efficacy and safety as existing products, for example in terms of its effect against omicron and other variants of concern. 
NPRA Notice
Philippine FDA finalizes guidelines on cutting burden of maximum retail price labeling
The Philippine Food and Drug Administration (FDA) has finalized the maximum retail price (MRP) labeling guidelines that it released for consultation earlier this year.
In finalizing the document, FDA has deleted a list of materials that the draft requested in relation to drug products that are already registered. The section now states companies “shall submit a letter with the facsimile of the label for the change or inclusion of the price or MRP statement.”
FDA has also added requirements for drug products granted generic labeling exemptions (GLE) and those delisted from the MRP. Regarding GLE products, FDA said “the MRP statement can be attached as a sticker on the secondary packaging of the drug product.” Delisted products can “revert to regular product label without the MRP statement.”
Final Guidelines


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you