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Asia-Pacific Roundup: TGA seeks feedback on nanomaterial in medical device regulations

Posted 02 March 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA seeks feedback on nanomaterial in medical device regulations

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on the introduction of specific requirements for medical devices containing nanomaterials. TGA is considering adding new definitions and amending essential principles or creating new classification rules.
Materials that range from 1 to 100 nanometers in size are typically considered to be nanomaterials. There are concerns about the impacts of such materials on health and the environment. Those concerns are underpinned by evidence that nanomaterials have different physicochemical properties than their parent materials and uncertainties about the effect of widespread use of the substances.
European legislators responded to the concerns by addressing nanomaterials in the forthcoming Medical Device Regulations (EU MDR). The regulations feature definitions, essential principles and classification rules specific to nanomaterials, as well as explanations that the requirements increase the robustness of the assessment process and account for risks associated with the technical design and manufacture of devices.
TGA, which the Australian government has asked to align with the European Union wherever possible, is considering introducing similar requirements and has proposed three options.
One option is to leave the regulations unchanged. The existing regulations already implicitly cover nanomaterials in a provision that states “particular attention must be given to the chemical and physical properties of the materials used in the device, and the compatibility between the materials used and biological tissues, cells, body fluids and specimens.”
The second option is to add definitions and amend essential principles. Those changes would align parts of the Australian regulations with the EU but leave the required regulatory oversight of medical devices incorporating nanomaterials unchanged. That is TGA’s preferred option.
The final option is to introduce new classification rules and, in doing so, potentially increase the regulatory requirements on medical devices that feature nanomaterials. In the EU, medical devices incorporating nanomaterials are treated as either Class IIa, Class IIb or Class III products. The highest risk category is reserved for products that present a high or medium potential for internal exposure.
TGA said the second and third options could be applied separately, thereby creating either new definitions or new classification rules. However, TGA thinks it makes little sense to add classification rules without at least creating new definitions for nanomaterials.
The changes could have significant effects on some manufacturers. TGA notes that gloves containing nanomaterials are currently treated as Class I or Class IIa devices, depending on whether they are used to examine patients or in surgical procedures. If TGA introduces new classification rules, gloves containing nanomaterials could become Class IIb or Class III medical devices.
TGA wants to know which option the medical device industry and other stakeholders would like to see implemented. The agency is also seeking feedback on the impacts of the proposed changes. TGA is accepting feedback until 9 April.   
TGA Notice, Consultation Document
CDSCO to switch to online serious adverse event filings this month
India’s Central Drugs Standard Control Organization (CDSCO) is to switch to an online system for filing serious adverse event (SAE) reports via the Sugam online portal and may stop accepting physical copies from 14 March.
CDSCO is moving the industry to online filing in a belief the new system will “further reduce the time and transaction cost” associated with the management of SAE reports, according to a notice released 25 February, noting also that companies can continue to submit physical follow-ups for events that are already in the system.
CDSCO has created a manual and video tutorial to help companies file SAE reports using Sugam. India introduced the portal in 2015 but the transition of regulatory processes to the system was slowed by complaints and subsequent efforts to improve the portal.
CDSCO Notice
TGA overhauls guidance on how identifying, managing product risks
TGA has overhauled guidance on its approach to risk management. The new text is far shorter than its predecessor but still addresses how TGA considers risks related to the different types of products it regulates.
Version 4.0 of the guidance, which TGA released in 2011, spanned 45 pages. TGA has condensed version 5.0 to 12 pages. The restructured guidance covers the role of TGA before briefly detailing how the agency manages risks associated with the use and manufacture of medicines, blood and haematopoietic progenitor cells, biologicals and medical devices.
In the section on medicines, TGA outlines its various risk-management options, such as the refusal to register products with risks that outweigh the benefits. TGA also discusses its approaches to the licensing of Australian manufacturers and assessment of overseas manufacturers.
Other sections of the guidance address the monitoring and review of medicines and medical devices, compliance, and communication and consultation with internal and external stakeholders.
TGA Guidance
Malaysia’s NPRA updates advice on API information needed to register products
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance on active pharmaceutical ingredients (API). The sixth version of the advice on the API information needed for product registration features multiple changes from its predecessors.
NPRA has removed topics that are now covered by the Drug Registration Guidance Document, which was updated in January, from the API document. Elsewhere, NPRA has added sections to the text.
The revised API guidance features a new section on the mode of submission for Drug Master Files (DMFs). NPRA added the section as it is now encouraging companies to submit digital DMFs. The new guidance describes the process for sending digital DMFs to NPRA.
Another new section covers product registration applications that reference APIs prequalified by the World Health Organization. The guidance now outlines the submission requirements and lists the information applicants need to include in the Letter of Access from the DMF holder.
NPRA has also updated an annex with the addition of cetylpyridinium chloride, mannitol and malic acid as examples of atypical APIs.
NPRA Guidance
TGA outlines planned expansion of Mask Testing Forum to tackle technical issues
Australia’s National Measurement Institute (NMI) is planning to expand the Mask Testing Forum it set up last year to facilitate informal technical discussion. TGA is encouraging sponsors and manufacturers of medical device face masks and respirators to join the forum.
NMI, part of the Department of Industry, Innovation and Science, set up the group last year to solve technical questions and, in doing so, accelerate the development of Australia's mask testing capabilities. Initial areas of focus included how to ensure confidence in the results of mask tests and understand the comparability of data generated at different sites.
While the Australian mask supply crisis has passed, NMI is continuing the forum and wants to build on the progress made so far. In expanding the initiative, NMI wants to support the development of collaborative solutions to pre- or noncommercial technical issues affecting the industry.
TGA Notice


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