For the first time, the European Commission completed an investigation under the International Procurement Instrument (IPI) and implemented measures to limit the participation of economic operators from non-EU countries – in this particular case, China – in the EU public procurement market. After EU suppliers of medical devices have arguably been denied fair access to Chinese government contract opportunities for years, the EU has now responded with Implementing Regulation (EU) 2025/1197 that requires contracting authorities/entities in all EU member states to exclude Chinese suppliers – and to a certain extent products manufactured in China – from larger public procurement contracts for medical devices.
In response to heightened scrutiny over country of origin declarations amid ongoing global tariff tensions, Singapore Customs issued Circular No. 06/2025 on 9 June 2025 to provide important clarification on the applicable preferential and non-preferential rules of origin when declaring the “country of origin” for importation into, exportation out of, and transshipments through Singapore.
Product regulation and safety is a key area of focus for consumer protection authorities around the world. In…
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.
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.
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.
ASIC has released a draft regulatory guide alongside a consultation paper intended to help providers of Buy Now Pay Later services understand the modified responsible lending obligations and requirements.
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.
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.
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.