Asia-Pacific Roundup: Singapore’s HSA starts SaMD change management pilot project

Singapore’s Health Sciences Authority (HSA) has started a pilot scheme for an optional software as a medical device (SaMD) regulatory pathway. The pilot, which applies to SaMD including devices enabled by machine learning, will assess the use of HSA’s change management program.

HSA has incorporated the program into its premarket product registration and change notification processes and introduced the concept of pre-specified changes. Companies can enroll in the program, which kicked off on 4 December, by applying to HSA.

HSA published final guidance on the program alongside details of the pilot scheme. The guidance frames the program as a response to the belief that the “prevailing regulatory framework may not be suited to accommodate the rapid iterative nature of SaMD.” Adhering to requirements such as the need to obtain approval for software changes poses challenges, HSA said, and can affect the implementation of updates.

“Adoption of [a] modern regulatory framework that embraces agile methodologies and risk-based assessments is necessary to help to expedite the approval process for certain types of changes, especially those aimed at maintaining and improving the effectiveness and safety of SaMD,” HSA said.

Enrollment in the program is limited to companies with “good quality management system practices with excellent capabilities in SaMD design and development, verification/validation, as well as effective post-market surveillance and vigilance to ensure the safety, effectiveness and cybersecurity of the SaMD throughout their [total product life cycle],” HSA said.

Robust quality assurance processes are needed to show an SaMD product is “designed, developed and maintained in a manner that ensures its safety and effectiveness,” HSA said. The processes also give HSA confidence that updates “are made in a controlled and systematic manner, without compromising [the device’s] safety or performance.”

Companies accepted into the program will be able to pre-specify specific changes that they intend to make in the future. Typically, such changes would require a change notification application. Companies in the change management program can avoid that step by telling HSA in advance about planned updates that fall within the intended use and original indication of the SaMD.

HSA will only accept updates that are intended to maintain or improve safety and effectiveness, without introducing new risks that are not adequately converted in the existing risk management framework. The agency said improvements to existing software functions, additions of new applications and changes to input data that do not affect the clinical output are examples of acceptable pre-specified changes.

The program applies to SaMD including devices enabled by machine learning; continuous learning and generative artificial intelligence technologies were excluded from the scope.

HSA Notice

India reforms committee to consider compensation for recipients of J&J hip implants

India’s Central Drugs Standard Control Organisation (CDSCO) has reformed a committee to “determine the quantum of compensation in respect of faulty” hip implants made by a Johnson & Johnson company.

DePuy, a J&J subsidiary, recalled articular surface replacement (ASR) hip prostheses globally in 2010. The recall followed reports of pain and disability in recipients of the metal-on-metal implants. India formed a committee to examine the reports, including cases when patients reportedly needed premature revision surgery, in 2017 and suggested a base compensation of 20 lakh Rupees ($23,610) per patient in 2018 (RELATED: India Orders Payments From J&J’s DePuy Over ‘Faulty’ Hip Implants, Regulatory Focus, 05 September 2018).

In September, India’s National Consumer Disputes Redressal Commission ordered J&J to pay two women 35 lakh Rupees each. The women had reportedly suffered medical and financial hardships, including being forced to give up a job, because of the faulty implants. The commission said the devices “suffer from inherent manufacturing defects and released a harmful amount of metal debris, which was poisonous.”

CDSCO reconstituted the central expert committee to consider compensation for recipients of the DePuy implants last week. The agency asked affected patients who have yet to submit a claim application to the committee or a state-level body to approach one of the government groups looking into compensation. Patients can email details of their cases to the central expert committee.

The notice about the reformation of the committee makes no mention of a timeline for determining the level of compensation. Many recipients of the implants will now be senior citizens. The two women who received the 35 lakh Rupee awards were 46 and 52 years old when they received the implants. J&J recalled the devices 14 years ago.

CDSCO Notice

Japan’s PMDA tells flu test manufacturers to assess impact of vaccines on results

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has told manufacturers of in vitro diagnostic (IVD) products that detect influenza viruses to check if their results are affected by a vaccine.

The request relates to the use of an intranasal live attenuated influenza vaccine. The mechanism of action, which mimics a natural infection, could affect the results of IVDs designed to detect influenza. The vaccine label carries a statement about its potential effect on rapid tests.

PMDA has asked rapid test marketing authorization holders to determine whether their results may be changed by viruses in the samples of people who have received an intranasal live attenuated influenza vaccine. Confirmation based on the verification test results is not necessarily required, PMDA said.

Companies that find their products may be affected by the vaccine need to check their labels. Products with the nonproprietary name of “OTC SARS-CoV-2 & Flu virus antigen kit” need to include a statement about the potential for their tests to deliver positive results “for a certain period after vaccination.” A similar statement is required in the packs of other affected influenza IVDs.

Manufacturers of affected products that lack the required statements need to “promptly” revise their package inserts, PMDA said. The Japanese regulator has asked companies to report their results, and any label changes, to its Office of Vigilance and Standards for Medical Devices by 27 December.

PMDA Notice

Australia’s TGA shares recall and defect alerts about Roche and Insulet diabetes devices

Australia’s Therapeutic Goods Administration (TGA) has shared details of a recall of a Roche insulin cartridge and a product defect for an Insulet insulin delivery system.

The recall affects Roche’s Accu-Chek Spirit 3.15 ml cartridge system. A manufacturing problem created the potential for insulin leaks. The leaks, which can occur at the luer connection, may not be detectable immediately and could lead to the under-delivery of insulin. Users should check if their cartridges are affected and stop using products that may suffer from the fault.

TGA’s product defect alert covers Insulet’s Omnipod DASH Personal Diabetes Manager (PDM) U100. The company has received complaints about battery depletion since Australian mobile service providers deactivated 3G networks.

PDM devices constantly try to look for a network when unable to find the 3G connection, causing the battery to run down faster than in normal operations. The battery drain could leave patients unable to deliver bolus insulin. To mitigate the risk of underdosing, TGA is advising users to put affected devices in airplane mode.

Roche Recall, Insulet Alert

Asia-Pacific Roundup: Singapore’s HSA starts SaMD change management pilot project

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