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In International

International: FDA to enhance unannounced inspections of foreign manufacturing facilities in countries including China

by , and 4 Mins Read

On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities. The expansion will build upon FDA’s existing Foreign Unannounced Inspection Pilot Program in India and China, with the aim of ensuring that foreign facilities will receive the same level of regulatory oversight and scrutiny as domestic facilities.

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In Product Regulation & Liability

United States: Electronic shelf labels pose myriad risks for retailers

by , and 3 Mins Read

Retailers are increasingly adopting electronic shelf labels (ESLs) to streamline pricing updates and enhance operational efficiency. ESLs offer quick price adjustments, improved accuracy, and reduced labor. However, concerns about price gouging, demographic-based pricing, and technical glitches have emerged. Lawmakers and regulators are scrutinizing the technology, emphasizing the need for businesses to consider legal risks before deployment.

In Cybersecurity, Data and Tech

Singapore: Health Sciences Authority launches public consultation on the Best Practices Guide for Medical Device Cybersecurity

by and 3 Mins Read

On 10 March 2025, the Health Sciences Authority launched its public consultation for the draft on the Best Practices Guide for Medical Device Cybersecurity. The document provides medical device manufacturers and healthcare providers with best practice recommendations and considerations on general cybersecurity principles to protect the security of medical devices for their entire product life cycle.

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In Product Regulation & Liability

Singapore: Ministry of Health announces reforms to the industry with updates to the regime under the Healthcare Services Act

by and 3 Mins Read

On 7 March 2025, the Ministry of Health announced a host of changes to the healthcare system to address the shifting needs of the Singapore population. These changes included a review of advertising regulations for certain healthcare professionals, the recognition of family medicine as a medical specialty and the introduction of registration requirements for psychologists.

In Product Regulation & Liability

Ukraine: Further ACCA implementation — new Ukrainian standards on market surveillance and e-commerce

by 4 Mins Read

The Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) is an intermediary step for Ukraine to benefit from the mutual recognition of product quality between the EU and Ukraine until our country becomes a full EU Member State. The ACAA covers 27 groups of industrial goods/technical regulations. Ukraine’s ACAA implementation plan was sequenced in priority sectors to allow a step-by-step sectoral implementation of the ACAA.

In Product Regulation & Liability

Ukraine: GPSR – Updated EU product safety rules – Overhauled requirements for the Ukrainian products heading to the EU consumer

by 3 Mins Read

On 13 December 2024, the new “Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on General Product Safety” (“GPSR”) came into force.
The GPSR repeals the General Product Safety Directive (2001) and introduces an updated regime to ensure product safety in light of evolving technologies and means of trade. As a regulation, the GPSR is directly applicable to all EU member states without the need for national transpositions.

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In Product Regulation & Liability

United Arab Emirates: Enacts new pharma law to boost pharmaceutical innovation

by , , and 5 Mins Read

On 1 October 2024, the UAE Government has issued a new Federal Decree-Law No. 38 of 2024 to regulate medical products, the pharmacy profession and pharmaceutical establishments (the “Law”).
The Law replaces Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments including its later amendments. However, its implementing regulations remain in effect to the extent they do not contradict with the Law.

In Asia-Pacific

Singapore: Health Sciences Authority cracks down on 3,300 e-commerce listings for illegal health products

by and 4 Mins Read

The Health Sciences Authority (HSA) conducted a large-scale operation in collaboration with major e-commerce and social media platforms, removing over 3,300 listings of illegal health products. The operation highlights the HSA’s commitment to consumer safety, targeting substandard or counterfeit products that are potentially unsafe and pose health risks.

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