Asia Regulatory Roundup: Industry Questions TGA’s Ability to Enforce Proposed Software Rules

RoundupsRoundups | 12 November 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Medtech Industry Questions TGA’s Ability to Enforce Proposed Software Rules
The medtech industry has questioned whether the Therapeutic Goods Administration (TGA) can ensure all Software as a Medical Device (SaMD) products are included in the Australian Register of Therapeutic Goods (ARTG).
TGA proposed mandating the inclusion of SaMD products in the ARTG when it ran a consultation on how to regulate medical software earlier this year. Currently, Australian consumers can download SaMD products developed and made available overseas. This means consumers can access products that lack an Australian sponsor. As TGA has limited oversight over such products, it wants to exclude SaMD products from the personal importation provisions that make foreign downloads legal today.
The proposal received support from parts of the industry, with Roche, for example, applauding TGA’s “efforts to ensure that all SaMDs have the necessary regulatory oversight and meet safety, quality and performance requirements.”
However, other parts of the industry are skeptical about the impact of the idea. Becton Dickinson (BD), for example, noted that the change would criminalize the downloading of unregistered SaMD products. As TGA thinks “millions of Australians” may have downloaded SaMD products under the current personal importation provisions, criminalizing that behavior could have big implications for the agency’s workload and financial requirements.
“With current resources the TGA does not have the ability to enforce this proposal should it be implemented,” BD wrote. “Should the TGA seek adequate resources to enforce the proposal within the existing cost recovery model, the question as to who will pay for these resources needs to be addressed. Certainly BD, and presumably the wider Australian MedTech Industry, would be unwilling to contribute to such costs.”
The Medical Technology Association of Australia (MTAA) also questioned whether TGA can stop users from downloading SaMD products from websites hosted outside the nation. Despite that concern, MTAA expressed support for TGA’s planned exclusion of SaMD products from provisions on personal importation.
MTAA was more critical of the risk classification proposed by TGA, noting that the “rules appear to be uniquely Australian, with no direct equivalence with the risk classification rules for SaMD in the IMDRF guidance document or the risk classification rules for software in the EU MDR.”  The trade group wants TGA to align its risk classification criteria with those of the International Medical Device Regulators Forum.
TGA is yet to fully articulate its response to the feedback, but has already held face-to-face meetings with respondents. The follow-up interactions “reinforced the consultation results for regulation to continue to be risk and principles based and internationally harmonized,” TGA wrote. TGA plans to engage in more consultation next year and continue to create guidance materials.
Industry Feedback
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on planned changes to the warning and advisory statements for paracetamol. Medsafe floated the new labeling requirements in response to cases of acute liver failure linked to suspected overdoses.
New Zealand last changed its rules on the labeling of paracetamol products in 2013. Any company that applied to sell a new product or sought a new label for an existing product after December 2013 has to include pediatric dosing information that is “consistent” with a table provided by Medsafe. The table features maximum doses for narrow ranges of body weights and ages, such as 1 to 2 years.
A simpler set of requirements applies to products that came to market before December 2013. Key differences include the use of broader age ranges, such as 1 to 5 years old, and the lack of details on how dosing is tied to the weight of the child.
Medsafe, responding to serious case reports reviewed by the Medicines Adverse Reactions Committee, wants to stop grouping paracetamol products based on whether they came to market before or after 2013. Rather, Medsafe plans to group the products into liquid oral dose forms, modified release products and all other dosage forms.
Before making the changes, Medsafe wants to hear what people affected by the proposals think of the new dose form groups. Medsafe has also asked whether its proposed paracetamol dosing table is appropriate and whether a measuring device should be provided. The revised table states the volume of different strength liquid paracetamol that can safely be given to children of different ages.
Medsafe is collecting feedback on the proposals until the end of January. As it stands, Medsafe plans to implement the changes within 18 months of publishing the outcome of the consultation.
Medsafe Consultation
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products
TGA has published advertising guidance for providers of stem cells and other human cell and tissue (HCT) products. The agency created the guidance after learning that companies are using terms such as “stem cells” in the promotion of HCT products, in violation of the advertising rules.
To help companies comply with the rules, TGA has published guidance explaining that products it regulates as biologicals, such as stem cells, cannot be advertised directly to the public. Companies can promote health services that involve HCT products, but only if they avoid any references to the therapeutic good.
TGA walks through the implications of the ban on all references to HCT products in the guidance, noting that it affects what people can call their business and products, plus the images they use in their materials.
“If your business name includes a reference to HCT products, it is likely that a consumer viewing the service promotion would reasonably consider that the service includes the use of HCT products,” TGA wrote.
That means references to HCT trade names, abbreviations and colloquial terms are banned, as are images that “would draw the consumer's mind to an HCT product.”
TGA published the guidance in response to the complaints it has received since taking charge of the enforcement of advertising rules. In its annual advertising report, which featured a cell therapy case study, TGA said it was working on guidance about HCT products, medicinal cannabis and disease education.
TGA Guidance
Indian Importers of Imaging Equipment Seek Exemptions From Drugs Licenses
Importers of imaging equipment into India have asked the Central Drugs Standard Control Organization (CDSCO) to exempt them from drugs sale licenses.
The request centers on 20B and 21B, forms related to the wholesale drug license. Under CDSCO’s plans to treat imaging equipment as drugs for regulatory purposes, importers of the devices would need to obtain the licenses. CDSCO received a request for an exemption from the requirements last month and has agreed to consider the idea.
“The importers of such equipments need to maintain all records of transactions, installations, maintenance, agreements etc. Accordingly, proposals will be officially moved to [the Drugs Technical Advisory Board] for exemption from Drugs Sale License,” VG Somani, the drugs controller general of India, wrote.
Somani asked stakeholders to send in comments on the proposed exemption.
CDSCO Notice
Other News:
TGA has published consumer information about the cybersecurity of medical devices. The document provides some questions consumers should ask to understand the potential risks associated with a connected medical device. TGA also provides information on how to secure medical devices and what to do in the event of a cybersecurity breach. TGA Guide


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