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Product Regulation & Liability

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The MHRA has been accepted as a full member of three groups: the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. These partnerships bolster the MHRA’s position as an influential international player in medicinal and medical device regulation and restore the MHRA’s ties with the IMDRF and ICH.

In the wake of last month’s collapse of the TerraUSD token, a broad array of regulators and government officials have attempted to introduce a legal framework around stablecoins. Last week, Senators Lummis and Gillibrand introduced a bill into the US Congress that would, among other things set requirements for the amount of backing assets stablecoin issuers would be required to hold.

In April 2022, the Health Sciences Authority published its revised Regulatory Guidelines for Software Medical Devices. It has also finalised its new Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Software, which had been released for public consultation in July to August 2021.

On 2 June 2022, ASIC published the updated ePayments Code which it states will strengthen and clarify a number of existing protections for consumers relating to various forms of electronic payments. The Code has generally been the benchmark for consumer protections for payments and transactions that were triggered within the world of online and mobile banking. It has been an added level of regulation for its subscribers which include most banks, credit unions and building societies in Australia.

By means of Resolution 464/2022 published on the Official Gazette on 27 May 2022, the domestic trade secretariat approved the form that suppliers must submit to alert consumers and competent authorities and recall products from the market. It also establishes certain obligations that suppliers that have initiated this type of process must comply with.