Asia-Pacific Roundup: TGA seeks information from medical devices manufacturers at the point of care

Australia’s Therapeutic Goods Administration (TGA) is gathering feedback on the regulatory needs of sites that manufacture medical devices at the point of care. The consultation is part of TGA’s efforts to understand how the framework for custom-made devices applies to point-of-care device production.

In 2021, the Australian government introduced a framework intended to apply an “appropriate” level of regulation to personalized, custom-made devices. The regulatory framework changed the definition of custom-made medical device and, in doing so, required the manufacturers of most products that were previously supplied under an exemption to add their devices to the Australian Register of Therapeutic Goods (ARTG). Products supplied in volumes of more than five a year need to be in the ARTG.

Now, TGA is working to understand how the framework applies to manufacturing at the point of care and “what refinements could be made to ensure regulation is appropriate without introducing unnecessary burden for point-of-care facilities.” The initiative led TGA to post a survey aimed at manufacturing hubs operated by a point-of-care facility, manufacturers based in a point-of-care facility and academic sites.

One question asks respondents what would help them, and their facility, meet their regulatory obligations for medical devices. The agency also asked manufacturers where they expect to be able to find information about their regulatory obligations, such as from the administration who runs their facility and TGA, and posed multiple questions about the respondents’ organizations.

TGA released the consultation alongside three related surveys aimed at allied healthcare professionals, dental and oral health professionals and hospital and healthcare facilities. Each survey is intended to provide TGA with information about how to refine the custom-made medical device regulations to avoid unnecessary burdens. The surveys are tailored to the different sets of stakeholders involved in the point-of-care production of medical devices.

TGA is accepting responses to all the surveys until 7 May. The regulator has clarified that the information provided will only be used to inform refinements to the regulatory framework and will not be used for compliance activities.

TGA Survey

Philippine FDA again delays implementation of new rules to avoid disruption to medical device market

The Philippine Food and Drug Administration (FDA) has delayed the implementation of new rules on the registration of medical devices for a second time due to the risk that the “strict implementation” of the requirements would disrupt the supply of devices and delivery of care.

In August 2021, FDA gave manufacturers, importers and other stakeholders that handle Class B, C and D medical devices until 31 March 2023 to obtain a Certificate of Medical Device Notification (CMDN). After that date, FDA was to stop accepting CMDN filings and require manufacturers to secure a Certificate of Medical Device Registration (CMDR).

The original plan, released in 2018, was to require Class B, C and D devices to obtain a CMDR. The CMDN was for Class A devices, the lowest risk category under the ASEAN Medical Device Directive that covers the Philippines and other countries in the region.

By April 2022, the agency had rethought its proposal. Under the revised plan, devices that were already on the market before 1 June 2022 could continue to be sold without a CMDN until 31 March 2023. From 1 April, manufacturers would at least need a pending CMDN filing.

Days before the deadline, FDA has rethought its proposal for a second time. The agency will now accept CMDN applications for Class B, C and D medical devices until 31 March 2024. FDA will stop accepting any CMDN filings for the three classes of device after that date. From 1 April 2024, the agency will only accept CMDR submissions and all devices will need to be covered by at least a pending CMDN or CMDR submission. Companies need to apply for a CMDR at least six months before their CMDN expires.

FDA made the changes because “strict implementation” of the requirements would create “a risk that supply of medical devices in the market will be negatively affected which may cause disruption in the health care service delivery in the country.” The agency “recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN common submission dossier template in applying for CMDR.”

FDA Circular

Indian Pharmacopoeia Commission releases draft on vaccine quality control

The Indian Pharmacopoeia Commission (IPC) has published a draft general chapter on vaccine quality control that provides guidance on using in vitro methods rather than in vivo tests for human and veterinary vaccines.

As IPC explains, in vivo potency and safety assays have historically played a central role in safeguarding the quality of vaccines. However, “the inherent variability” of the assays can make them “less suitable than appropriately designed in vitro assays for monitoring consistency of production and for assessing the potential impact of manufacturing changes.”

When in vivo tests have little or no value, IPC wants to eliminate them “given the ethical considerations and the obligations under the relevant conventions.” To support that goal, the draft describes considerations for transitioning to in vitro tests.

The draft released to the public features tracked changes, including a section headed “General Comments from Sanofi.” The comment says the text “is very welcome in order to help set guidance on substituting in vivo methods by alternative non animal-based methods which allow to introduce more reliable assays to demonstrate product quality, efficacy and safety” but warns the draft contradicts its references in parts.

Draft Document

TGA changes medical device essential principles for nanomaterials to clarify existing obligations

TGA has changed an essential principle to explicitly require manufacturers of medical devices to pay particular attention to the chemical and physical properties and biocompatibility of nanomaterials.

The obligation to pay attention to the properties already existed but the updated essential principle provides additional detail to clarify the requirements. In a new subsection on nanomaterials, TGA wrote that medical devices must be designed and produced to minimize “risks associated with the size and the properties of particles which are, or can be, released into a patient’s or user’s body.”

Subsequent points state that “particular attention must be given to the use of nanomaterials” and that the requirement “does not apply to particles that come into contact with intact skin only.” TGA updated its essential principles checklist for medical devices in conjunction with the change.

TGA Notice

Asia-Pacific Roundup: TGA seeks information from medical devices manufacturers at the point of care

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