The UK government has announced that the implementation of the future UK Medical Device Regulations will be pushed back from 1 July 2023 to 1 July 2024. The MHRA’s announcement means that CE-marked products will continue to be accepted in Great Britain and manufacturers will only be required to obtain a UK Conformity Assessed mark from July 2024. As a result, this extension will provide manufacturers an extra year to ensure that their products are compliant with the new UK regime.
The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024. In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.
We’re pleased to present the eighth edition of Ukrainian Laws in Wartime: Guide for International and Domestic Businesses, a brief overview of the key features of wartime legislation.
This issue contains updated responses to the most common questions raised and considered by international and Ukrainian businesses.
On 19 October 2022, the Health Sciences Authority issued an alert on fake HSA accounts on the TikTok platform. The HSA stated that it does not have a TikTok account and advised members of the public not to click on any links or respond to these fake accounts.
The Ministry of Communications and Information tabled the Online Safety (Miscellaneous Amendments) Bill for its first reading in Parliament on 3 October 2022, setting out proposed regulations of providers of online communication services with significant reach or impact accessible by any Singapore end-user, as well as measures to prevent access to egregious content. The aim of the Bill is to enhance online user safety, particularly for children, and to curb the spread of harmful content on OCS. Designated providers of such OCS will have to comply with Codes of Practice issued by the Info-communications Media Development Authority to enhance online safety for Singapore end-users and curb the spread of harmful content on their service.
In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking to harmonize telemedicine from the draft European Health Data Space. The (now-removed) Article 8 was aimed at encouraging the cross-border provision of telemedicine services across the EU. However, the reality is that there are vast national differences between Member States on telemedicine-related laws. It is going to require a far more concerted legislative effort to harmonize this area of law across the EU.
Baker McKenzie was invited to serve as the global editor of the Chambers Advertising & Marketing 2022 Practice Guide which features 8 high-profile jurisdictions and provides the latest legal information on the impact of the COVID-19 pandemic, advertising claims and clinical studies, comparative advertising, social/digital media, influencer campaigns, consumer promotions, sports betting/gambling, and cryptocurrency and non-fungible tokens.
The 14th edition of the Insurance Outlook, researched and written by our knowledgeable lawyers in the Insurance Practice Group, offers an overview of the insurance sector in Thailand and is intended as an informative digest of the insurance sector’s most prominent aspects based on the latest reported data.
The Regulation on the Amendment of the Distance Sales Regulation was published in the Official Gazette on 23 August 2022. Save for the provision regarding the obligation of the card issuer on refunds of the amount transferred by the seller, service provider or intermediary service provider, which will enter into force on 1 January 2023, the amendments came into force on 1 October 2022. The Ministry of Trade has made significant amendments to the provisions regarding the scope of the Distance Sales Regulation, the obligation of prior notification, the right of withdrawal, and the obligations of the seller, service provider and consumer. With the amendments, the Distance Sales Regulation has been aligned with the amendments introduced to the Consumer Protection Law on 1 April 2022.
Indonesia’s Consumer Protection Law generally takes a light-handed approach to protection of consumer interests. It generally seeks to lay out the principles for protecting consumers’ interests, leaving detailed regulations to the regulators and to industry self-governance. However, it does list specific types of clauses that are prohibited. Anyone who includes prohibited clauses in an agreement would be subject to the threat of criminal penalty of up to five years imprisonment or a fine of up to IDR 2 billion (around USD 130,000). Given these risks, it is crucial for any consumer-facing business to understand what types of clauses are actually prohibited and how it can ensure that it is compliant with these prohibitions.