Regulatory Focus™ > News Articles > 2021 > 7 > Asia-Pacific Roundup: Singapore seeks feedback on regulation of SaMD

Asia-Pacific Roundup: Singapore seeks feedback on regulation of SaMD

Posted 27 July 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: Singapore seeks feedback on regulation of SaMD

Singapore’s Health Sciences Authority (HSA) has released for consultation draft guidelines on standalone medical mobile applications and qualification of clinical decision support software (CDSS).
 
The guidance draws on the International Medical Device Regulators Forum’s (IMDRF) guidance on Software as a Medical Device (SaMD). HSA, which uses the abbreviation SaMD to refer to standalone medical mobile applications, has combined elements of the IMDRF framework with details intended to provide clarity on the qualification of CDSS as regulated medical devices or otherwise.
 
In the draft, HSA proposes a SaMD risk classification that is based on the significance of information provided by the standalone mobile application to support a healthcare decision, the health of the patient and existing general rules on the categorization of medical devices. The guidance expands on the criteria, for example by defining when a SaMD will be involved in the treatment and diagnosis of a patient to help gauge the significance of the information it provides. 
 
HSA has provided a risk classification table to show how SaMDs will be categorized based on the criteria. If a SaMD is used to treat or diagnose patients in critical condition, HSA plans to categorize it as a Class C device. In contrast, devices that are only used to inform clinical management of patients with non-serious conditions will fall into the lower-risk Class A. The draft features examples of several types of SaMD and the thinking behind their risk classifications.
 
The rest of the document covers CDSS. As the guidance explains, not all CDSS products are medical devices. The guidance is intended to help identify CDSS products that are medical devices and to give risk classifications to the software.
 
Devices that do not meet the definition of a medical device in the First Schedule of Health Products Act or are intended solely for the display or printing of non-real time medical information will not be regulated as medical devices. The guidance also provides the criteria CDSS products need to meet to be categorized as Class A medical devices and a decision tree to help evaluate products, as well as several examples to illustrate the categorization process.
 
HSA is accepting feedback until 19 August.
 
HSA Notice
 
Liver injuries spur calls for TGA to rethink dietary supplement regulation
 
An analysis of liver injuries linked to herbal and dietary supplements in Australia has spurred calls for the Therapeutic Goods Administration (TGA) to change how it oversees the industry.
 
The study, details of which were published in the Medical Journal of Australia, analyzed information on patients admitted to a Sydney hospital with drug‐induced liver injury from 2009 to 2020. The data included 115 patients with injuries linked to paracetamol and 69 with injuries linked to other drugs. Herbal and dietary supplements were implicated in 22% of the non-paracetamol liver injuries.
 
Of the 15 injuries linked to herbal and dietary supplements, most occurred in the past few years. From 2009 to 2011, the hospital received two patients with liver injuries linked to supplements. From 2018 to 2020, the hospital received ten patients with liver injuries linked to supplements.
 
The proportion of non-paracetamol injuries linked to herbal and dietary supplements increased over the same period. From 2009 to 2011, supplements accounted for 15% of non-paracetamol injuries. By 2018 to 2020, that figure had risen to 47%. Anabolic steroids, bodybuilding supplements, traditional Chinese medicine and weight loss supplements were the most commonly implicated supplements.
 
The findings point to the need for a new approach from TGA, Ken Harvey, honorary adjunct associate professor of the Institute for Evidence-Based Healthcare at Bond University, said in an interview with a newsletter produced by MJA.
 
“A low-risk product does not mean there is no risk. The TGA should conduct more post-marketing surveillance on listed products, especially Chinese traditional and Ayurveda medicines that have been associated with adverse events, contamination and adulteration, and they should also publicize their findings,” Harvey, who is not an author on the paper, said.
 
MJA Paper, InSight+
 
Abbott, Roche among companies hit by new Indian medtech price caps
 
India’s National Pharmaceutical Pricing Authority (NPPA) has cut the maximum retail prices (MRPs) of a range of medical devices from manufacturers including Abbott and Roche.
 
NPPA shared plans to cap the trade margin on pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers and glucometers at 70% earlier this month as part of an attempt to control the prices of medical devices involved in the management of COVID-19. Having received information from manufacturers, NPPA has now shared details of the impact on prices.
 
The update reveals some steep declines in MRP, with the ceiling price for a pulse oximeter sold by Amkay falling 69% and other manufacturers of those medical devices experiencing similar declines.
 
Multinational medical device companies were among the businesses affected by the cuts, although they were spared the steepest reductions in MRP. The MRP for an Abbott glucometer is set to fall 22%, although the maximum price of its other two affected products are unchanged. One Roche product is the subject of a 13% cut in MRP with another five prices are unchanged. All of LifeScan’s MRPs are unchanged.
 
In the blood pressure market, the MRPs of many Omron products stayed the same or were only cut slightly. One Omron product was the subject of a 37% reduction in MRP, though.
 
NPPA Notice
 
India publishes risk classifications for in-vitro diagnostic medical devices
 
The Drugs Controller General of India (DCGI) has published a list of risk classifications for in-vitro diagnostics (IVDs) as part of a long-running effort to implement the Medical Devices Rules, 2017.
 
DCGI has divided the list up into IVD analyzers, instruments and software. IVD analyzers is the largest category, with 53 types of medical device, and features the only product class that falls into the highest risk group. DCGI has put analyzers for near-patient blood group testing in the highest risk group, Class D. Most of the analyzers are in the low-risk Class A.
 
All 19 IVD instruments are in Class A but the software list features five higher-risk devices. DCGI has put the five types of IVD software, which include products to assess cardiovascular and cancer risk, in Class C. The release of the IVD list follows shortly after DCGI assigned risk categories to anesthesiology medical devices.
 
DCGI Notice
 
TGA stops processing notifications for new active ingredient mixtures
 
TGA has stopped processing notifications for new ingredient mixtures with an active ingredient or a non-specific purpose into the Proprietary Ingredients (PI) Table.
 
In January, TGA outlined plans to eliminate the process on the grounds it is redundant and resource intensive. The consultation found support for plans to stop processing new active premixes, active herbal extracts and non-specific excipient mixes, although some respondents questioned whether it would have cost implications for companies with mixes that are already in the table.
 
TGA responded to the feedback by stopping processing notifications for the mixes on 20 July. “Ingredient suppliers can still sell these mixtures to sponsors intended for use in medicines, but sponsors will need to select the individual ingredients into their application at the same time as they enter the rest of their medicines’ formulation details,” TGA wrote. 
 
TGA Notice, Consultation Findings
 

 

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