Asia-Pacific Roundup: China updates GMPs for medical devices, starts 1-year transition to new rules

China’s National Medical Products Administration (NMPA) updated its guidance on good manufacturing practices (GMPs) for medical devices.

Officials published the previous version of the guidance in 2014. NMPA said the updated GMP guidance integrates the latest concepts of risk management throughout the whole lifecycle of medical devices. The agency has also tried to reflect new requirements for quality management system construction that have been established domestically and internationally in recent years.

NMPA said it has attempted to meet “the new demands for innovation and high-quality development of the industry” while also incorporating “new regulatory requirements in the digital-intelligence era.” The work has resulted in the addition of three new chapters on quality assurance, validation and verification, and contract manufacture and outsourcing. NMPA has also made changes to existing chapters.

The agency said the guidance, which has 15 chapters and 132 articles, has five overarching effects. First, NMPA said the guidance “further strengthens the concept of quality risk management, ensuring that risk management runs consistently from R&D design to after-sales service.” Second, the text strengthens the construction of quality assurance systems within quality management systems, ensuring the continuous stability of large-scale manufacturing processes, the agency said.

Third, the guidance “strengthens management requirements for new business models such as contract manufacture, clarifying responsibilities at each stage to ensure high-level safety across the entire chain,” NMPA said. Fourth, NMPA said the text emphasizes the importance of “the key link of ‘validation and verification’ in operation specification and improving output reliability, ensuring effective control of key elements in the product manufacturing process.”

The fifth and final objective is to encourage what NMPA calls “the digital-intelligent transformation in manufacturing.” Through the guidance, the agency said it wants to ensure “the effective application of artificial intelligence, information technology, and the Unique Device Identification system.”

The updated guidance, which will take effect on 1 November 2026, is part of efforts to provide a “solid institutional foundation” for ensuring the safety and effectiveness of medical devices sold in China. NMPA also framed the guidance as part of work to promote “the normative and orderly development of the medical device industry.”

NMPA Notice, More

Australia’s TGA revises guidance on advertising therapeutic goods on social media

Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on advertising therapeutic goods on social media.

TGA said it reassessed its guidance in response to an increase in unlawful advertising on social media. The agency has seen businesses, health services, and social media influencers promote prescription-only medicines such as Ozempic and cosmetic injectables, including Botox, on social media platforms in ways that breach Australian rules on drug promotion.

The updated guidance reflects TGA’s analysis of the unlawful posts, which the agency said, “Often use images, nicknames, hashtags, and influencer-style endorsements to promote the goods.” TGA’s previous guidance only made one reference to hashtags. Links, tags, and hashtags have their own section in the updated guidance.

Posts that use certain links, tags, and hashtags are more likely to be regarded as promotional. TGA cited the example of a pharma company that posts a link to a clinical trial report for one of its drugs to explain its position. Because the company has a financial interest in the medicine, a reader is more likely to view this as promotional than if the report was viewed with no additional context, TGA said.

A new section addresses corporate news and press releases, explaining that company announcements “should avoid mentioning prescription medicines and unapproved therapeutic goods, particularly alongside the product indication, therapy area, or key product benefits, as this is more likely to be considered advertising.”

The guidance also includes advice for companies that engage influencers. TGA is recommending that businesses review the content made by any influencers and content creators they engage with to ensure its compliance. Businesses may be responsible for the non-compliance of paid-for posts that influencers publish on their behalf.

TGA has clarified that business owners are responsible for “AI-generated or AI-assisted content that they manage and disseminate, including on social media platforms.” The agency named the dissemination of inaccurate and misleading information and use of false or misleading product reviews as examples of AI compliance risks. TGA said “deep fakes” are a specific compliance concern.

The guidance applies to historical and new social media posts. Each day an advertising contravention is present may be considered a new contravention of the Therapeutic Goods Act and related legislation, TGA said.

TGA Notice, Updated Guidance

New Zealand’s Medsafe yet to find defect in Sandoz patches as complaints continue

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has provided an update on its investigation into the efficacy and adhesion of Sandoz’s Estradot patches.

The regulator began investigating the patches, which deliver estrogen, last month in response to reports of menopause symptoms returning and patch adhesion issues. Medsafe provided an update last week, revealing that it has received 78 complaints about adhesion, loss of effect, or returning symptoms.

Most initial complaints related to one batch, 34,680 boxes from which were distributed in New Zealand. More than 17,000 boxes from the batch were distributed in Australia, where Sandoz has received no complaints. People in New Zealand complained about other batches following media publicity of the investigation.

Sandoz has retested the batch at the center of the investigation for shear adhesion, peel adhesion, and active substance content. The company confirmed the batch meets all these quality specifications. Sandoz retested another nine batches without finding any defects. Medsafe has asked Sandoz to retest additional batches associated with complaints.

A joint Medsafe-Sandoz investigation looked into manufacturing records, product testing, and storage and transportation conditions. The investigation found no deviations or temperature excursions for the batches shipped to New Zealand. Medsafe is continuing to investigate the product but is yet to find any evidence of a quality defect or evidence that any batch is faulty or warrants a recall.

Medsafe Update

Malaysia’s MDA advises companies hit by liquidation of conformity assessment body

Malaysia’s Medical Device Authority (MDA) has shared advice for medtech companies affected by the liquidation of a conformity assessment body.

Medcert Malaysia ceased operations in late August and is currently undergoing liquidation, MDA said. As part of the liquidation, the organization has stopped performing regulatory activities including providing conformity assessment services. MDA said the body is no longer authorized to conduct any conformity assessment activities.

The organization’s registration will remain valid until 20 November but will not be renewed. MDA has asked medical device establishments previously certified or assessed by Medcert Malaysia to transfer their certifications to another registered conformity assessment body. Companies must complete the transfers to maintain compliance with the Medical Device Act 2012.

MDA has advised companies to “initiate transfer arrangements as early as possible to avoid disruption in regulatory compliance and business operations.” The agency said it will continue to recognize certificates or approvals issued by the body prior to its cessation of operations “until the respective certificates or approvals reach their original expiry date.”

MDA Notice

Other News:

Hong Kong approved another drug under its “1+” mechanism, bringing the total number of products authorized via the pathway up to 15. Press Release

Asia-Pacific Roundup: China updates GMPs for medical devices, starts 1-year transition to new rules

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