Asia-Pacific Roundup: TGA outlines new measures to ID, manage device-related safety concerns

Seeking to improve patient safety by enhancing the identification and management of safety concerns, the Australian government will start requiring all public, private, and day hospitals to report injuries and suspected injuries related to medical devices. The mandatory reporting requirement will take effect on 21 March 2026.

“We welcome the additional data that hospitals will now provide under this new measure,” Anthony Lawler, head of the Therapeutic Goods Administration (TGA) said. “This enhanced reporting will play a critical role in helping the TGA to identify potential safety concerns earlier.”

The mandatory reporting requirement will come into force months before Australia implements a unique device identification (UDI) system. Starting July 2026, manufacturers supplying devices in Australia must use barcodes to identify their products on all packaging and labelling and submit this data to TGA.

TGA will run a public database of UDI information to enable patients to find details about their medical devices. Healthcare organizations can integrate the UDI information with their systems and patient records, including the government’s My Health Record, to accurately identify the specific medical device used. Lawler is encouraging healthcare professionals and providers to explore the capabilities of UDI.

The initiatives follow TGA’s work to create a stronger and more transparent recall process. TGA said it has adopted simplified terminology, streamlined processes, and enhanced legislative recall powers. The changes are intended to make it easier for suppliers and users to start and report product safety actions and improve the clarity of the recall information for patients, healthcare professionals, and users.

The agency highlighted updates on how medical device companies report problems, the need to share reports of near misses and feedback from users and healthcare workers, the transition to mandatory reporting by hospitals, and the creation of the UDI database as drivers of a rise in incidents.

TGA Notice, More

DRAP updates labelling guidance to mandate the use of machine-readable barcodes

The Drug Regulatory Authority of Pakistan (DRAP) has updated its drug labelling and packaging rules to require the use of machine-readable barcodes.

A new sub-rule of the Drugs (Labelling and Packing) Rules, 1986 states “a machine-readable Barcode shall be printed on the label of all drugs manufactured or imported for domestic market or for export purpose, at different packaging level to identify, tracking and tracing, to eliminate spurious and counterfeit products.”

The requirement applies to “allopathic drugs, including biological, for human and veterinary use only.” Manufacturers of “alternate medicines, health and OTC non-drug products, nutraceuticals, medical devices, medical gases or radio-pharmaceuticals” do not need to comply “till further order.”

DRAP has added a section to the legislation to communicate detailed requirements for the barcodes. The new section states products must carry “a GS1 Data-Matrix of a [two-dimensional (2D)] barcode type” that uses the Global Trade Item Number (GTIN) format, “in addition to batch or lot, expiry date, and serial number on the secondary packaging.”

Homogeneous products must include “a GS1-128 linear barcode of [one-dimensional (1D)] barcode type encoding a unique global product identification code in the format of GTIN, expiry date, batch or lot, serial shipping container code (SSCC) on the tertiary packaging.”

Manufacturers of heterogeneous products must add a 1D barcode that encodes the SSCC to the tertiary packaging. DRAP will make the SSCC tertiary packaging requirement mandatory six years after the barcode rules start. The transition period is subject to rules about the labelling of primary and secondary packaging.

Importers who bring products without the barcodes into Pakistan must add the information at a facility in the country licensed to make or sell drugs. The Registration Board must approve the printing of the GS1 data matrix, which must be present before imported drugs are put on the market.

DRAP Notice

HSA exempts more changes to registered devices from notification requirements

Singapore’s Health Sciences Authority (HSA) has updated its guidance on change notifications to exempt more revisions to registered medical devices from reporting requirements.

The list of actions that do not require the submission of a change notification now includes labelling changes with no new information related to safety and performance. HSA cited the addition of symbols to harmonize information between labels and instructions for use, the addition of warnings related to safe disposal of the device and changes to the design of existing symbols as examples.

HSA also exempted changes to material suppliers that do not affect the specifications of the registered medical device from the notification requirements. Companies must continue to notify HSA about changes to suppliers of medicinal substances and biological materials.

The agency also said companies should not submit notifications for changes to Class A devices. The medical devices are exempted from product registration rules but the dealers’ licensing and post-market regulatory requirements remain applicable.

HSA expanded the list of exemptions as part of a guidance update that added a flowchart to help developers of machine learning-enabled medical devices. The flowchart is designed to show which type of change applies to revisions to locked and continuous learning algorithms. Factors such as changes to the input data, indications for use, output results and approved workflow determine the requirements.

HSA Notice

India finds no direct link between COVID-19 vaccines and reports of sudden deaths

Indian health bodies said their studies have “conclusively established that there is no direct link between COVID-19 vaccination and the reports of sudden deaths in the country.”

The Indian Council of Medical Research and National Centre for Disease Control worked to understand “the causes behind sudden unexplained deaths, especially in young adults between the ages of 18 and 45 years.” The work included a retrospective analysis of unexplained sudden deaths among adults aged 18 to 45 years in India and a prospective trial to determine the causes of sudden deaths in young adults.

Government officials said there have been no major changes in the pattern of sudden death causes. In most cases, the researchers have identified genetic mutations as a possible cause of death. Researchers are yet to complete the study but said the interim results support the safety of COVID-19 vaccines.

“It has also been revealed that COVID-19 vaccination does not appear to increase the risk, whereas, the role of underlying health issues, genetic predisposition and risky lifestyle choices does play a role in unexplained sudden deaths. Scientific experts have reiterated that statements linking COVID vaccination to sudden deaths are false and misleading, and are not supported by scientific consensus,” officials said.

Press Release

Other news

TGA has initiated actions to reduce its backlog of good manufacturing practice (GMP) clearance applications. Starting 1 July, the Australian regulator will automatically extend mutual recognition and non-sterile active pharmaceutical ingredient GMP clearances. TGA said it “will advise in the coming weeks when this work is completed and next steps.” TGA Notice

HSA has begun the “progressive decommissioning” of the Medical Device Information Communication System (MEDICS). Officials are switching e-services for medical devices-related applications from MEDICS to the Singapore Health Product Access and Regulatory E-System from 14 July. HSA Notice

Asia-Pacific Roundup: TGA outlines new measures to ID, manage device-related safety concerns

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