Asia-Pacific Roundup: Singapore’s HSA queries on device evaluation guidance changes

Singapore’s Health Sciences Authority (HSA) is holding a consultation into planned changes to guidance on the clinical evaluation of medical devices.

HSA created the document to provide advice on the assessment and analysis of data to verify the clinical safety and performance of a medical device. The guidance covers general principles, as well as how to identify relevant clinical data, integrate it into a summary and create a clinical evaluation report. HSA last revised the guidance a year ago.

The latest draft features more than 20 proposed changes to the text. HSA is planning to almost totally rewrite, and significantly expand, sections on the purpose of the guidance and its background. The new text discusses the need for devices to conform with the Essential Principles of Safety and Performance (EP). HSA’s EP guidance predates the clinical evaluation document, and was referenced in earlier versions of the text, but is more of a focal point in the new draft.

“When placing a medical device on the market, product owners must have demonstrated through the use of appropriate conformity assessment procedures that the medical device complies with the EP,” the draft states. “Generally, it is expected that the product owner has demonstrated the medical device achieves its intended performance during use according to its labeling.”

In the expanded background section, HSA goes on to explain that “product owners are expected to implement and maintain surveillance programs that routinely monitor the safety and performance of the medical device as part of their Quality Management System.”

Most of the information about how product owners can meet their responsibilities is unchanged from the current text. Some of the changes in the main body of the guidance relate to comparable devices and standalone software. HSA is planning to add definitions of both terms to the document and discuss them in more detail in other sections of the text.

HSA is proposing to define comparable devices as medical devices “with related function chosen by the product owner to inform the clinical evaluation of the device in question.” A new section states that “comparable devices should be considered with respect to relevant aspects including intended purpose, technical and/or biological characteristics to inform the clinical evaluation of the medical device.”

Evidence and data from comparable medical devices “may support specific features or functions of the device in question in certain use cases,” HSA wrote, but it may not be sufficient to show compliance with the EPs. “Additional clinical evidence may still be necessary from other studies to address any gaps in the clinical evaluation and ensure compliance with the Essential Principles,” the guidance states.

HSA is also planning to add a section on standalone software, its term for software as a medical device. The draft states that “clinical evaluation is an ongoing process throughout the software's life cycle.” As such, companies need to continuously collect data after the software comes to market to ensure “new or evolving risks arising from the use of the software can be detected in a timely manner in its real-world clinical environment.”

Draft Guidance

Pakistan’s DRAP starts consultation on storage and destruction of recalled products

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on its proposed recommendations for the storage and destruction of recalled therapeutic goods.

DRAP drafted the guidance to help pharma manufacturers and importers ensure secure stock returns and “eliminate pilferage and liquefaction of the recalled stocks.” The regulator’s recommendations on how to achieve the goals cover areas including storage, distribution, transportation, documentation and record keeping.

Good distribution practices apply to drugs moving back to manufacturers, as well as to the medicines they ship to patients, according to the draft. The authority is advising manufacturers to collaborate with customs agencies, law enforcement and other groups to minimize the risk of supply chain breaches when recalling stocks. Preventing breaches is a focus of multiple sections of the draft.

“To prohibit the unintentional or unauthorized use of recalled pharmaceutical products, separate storage areas should be assigned for the temporary storage until a decision as to their future has been made,” the draft states. “The design and use of vehicles and equipment must aim to minimize the risk of recalled product damage and pilferage. Dedicated vehicles and equipment should be used, where possible.”

DRAP, which uploaded the draft on 27 October, is accepting feedback for 15 days.

DRAP Notice

Malaysia’s MDA readies for 1 November switch to electronic medical device certificates

Malaysia’s Medical Device Authority (MDA) is set to switch to electronic medical device registration certificates on 1 November.

In a notice to industry, MDA explained that companies will be able to download their device registration certificates from [email protected]+, MDA’s centralized online application system, once their application is complete and the payment of their registration fees has been cleared. [email protected]+ will be the only way for companies to access the certificates for applications approved after 1 November.

MDA will send out physical medical device registration certificates for applications it approves before 1 November. Companies that complete the application process before the transition date will also be able to download their certificates from [email protected]+.

MDA Notice (Malay)

Japan’s PMDA shares overview of first pharmacopeial meeting involving Indian group

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared a summary of the Pharmacopoeial Discussion Group (PDG) meeting earlier this month. The meeting marked the start of the Indian Pharmacopoeia Commission’s (IPC) membership of the PDG.

At the meeting, the IPC and the pharmacopeias of Europe, Japan and the US, the three original PDG members, discussed the expansion process that led to the addition of the Indian commission to the group. The discussion covered what “went well and challenges to address from the IPC perspective” but the summary lacks specifics.

“The operational impact of adding a pharmacopeia was also reviewed and the future strategy, structure, and organization of the PDG including further membership expansion were discussed. This is necessary to ensure the PDG continues to perform efficiently and effectively in the future,” the summary states.

The next meeting will take place in France in October 2024.

PMDA Notice

DRAP starts accepting online data submissions for manufacture, import and export filings

DRAP has started offering an e-service to facilitate online regulatory data submissions to support filings to register products in Pakistan for manufacture, imports and exports.

The service allows applicants to submit data through the eAPP portal. Companies need to register to use the portal. Once companies are set up on eAPP, DRAP expects the e-service to make the submission and processing of data faster and easier, reduce paperwork and redundancy, and increase transparency and visibility.

Officials framed the service as part of DRAP’s broader “transformation strategy,” which is designed to ensure “the quality, safety and efficacy of therapeutic goods in Pakistan.” DRAP also said the service will “facilitate the licensing and registration process and improve the regulatory system in Pakistan.”

The authority plans to “reach out to applicants in assisting application submission on this new e-service” and is seeking feedback and suggestions from companies that make online data filings.

DRAP Notice

Asia-Pacific Roundup: Singapore’s HSA queries on device evaluation guidance changes

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