Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kind of products and introduces provisions regarding the manufacture of in-house products and the reprocessing of single-use products, among other significant changes.
On 21 March 2023, the Authority of Broadcasting and Electronic Information (ABEI) under the Ministry of Information and Communications released a white list specifying local service providers whose online websites and/or social networks are verified and suitable for online advertisements (“White List”). This is part of ABEI’s initiative to encourage brands and advertisers to prioritize displaying advertisements on non-violating websites.
On 13 March 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on 9 February that it is planning for the declaration of the PHE to expire on 11 May 2023.
On 9 January 2023, the National Assembly of Vietnam issued Law No. 15/2023/QH15 on Medical Examination and Treatment, which sets out a significant number of new regulations on healthcare and medical activities. The New Law will take effect on 1 January 2024, replacing the current Law No. 40/2009/QH12 on Medical Examination and Treatment dated 23 November 2009.
On 7 February the decrees of the Ministry of Health aimed at aligning the Italian legislation with Regulation EU 536/2014 on clinical trials were published in the Official Gazette.
On 30 January 2023, the European Commission published a document on the application of Regulation UE 536/2014 on clinical trials to provide sponsors and investigators with a quick guide on the rules and procedures established in the same Regulation with a view to facilitating its implementation.
Supreme Decree No. 004-2023-SA approved the new “Regulations governing the Medicinal and Therapeutic Use of Cannabis and its Derivatives,” which will enter into force on 1 September 2023.
The publication of the July 2022 version of the European Commission’s Blue Guide on the implementation of European Union product rules aims to adapt to changes in European legislation on the marketing of products within the EU. In this sense, the aim is to improve the understanding of EU legislation and its application in the fields that make up the single market. The Guide is for guidance only, which means that it has no legal force. Among the most relevant changes are the introduction of specific sections on product repairs, software, online sales and Brexit.
Law No. 7435 on the Amendment of the Law on the Union of Chambers and Commodity Exchanges of Türkiye and the Chambers and Commodity Exchanges and Certain Laws and the Decree Law No. 640, published in the Official Gazette dated 1 February 2023 and numbered 32091, introduced significant amendments to Law No. 6585 on the Regulation of Retail Trade.
On 6 March 2023, FDA issued a Dietary Supplement Ingredient Directory. The Directory is hosted on the agency’s website and is intended to help the public quickly find what the FDA has said about a specific ingredient and whether the agency has taken any action with regard to the ingredient. Importantly, the Directory will replace the previous FDA Dietary Supplement Ingredient Advisory List, which listed ingredients identified by the agency as not lawfully marketed in dietary supplements.