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Covington & Burling LLP | United Kingdom | 20 Mar 2023
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital Technologies as…
Lexology PRO | Norway | 17 Mar 2023
Medical devices maker fined after two-month notification delay
The Norwegian regulator has fined Argon Medical Devices 2.5 million kroner for failing to report a data breach that compromised the personal data of all its European employees.
Sanchez DeVanny Eseverri SC | Mexico | 15 Mar 2023
Wellness: new target for regulation in Mexico
In the post-covid-19 pandemic world, the concept of "wellness" has become increasingly popular. However, there are various limitations and verification requirements for any products that promote their use for "wellness" or similar kinds of therapies or programmes. Given that the concepts of both "health" and "wellness" concepts are broad in their interpretation, the number of products and......
Smart & Biggar | Canada | 1 Mar 2023
Consultation open on Health Canada's proposal on agile licensing for drugs and medical devices
In July 2021, Health Canada announced its intent to amend the Food and Drug Regulations and the Medical Devices Regulations to modernise the regulatory system to permit agile licensing of drugs and medical devices. The proposed amendments to both regulations were recently published for consultation.
Eversheds Sutherland (International) LLP | European Union | 15 Feb 2023
European Commission issues proposal to extend MDR transitional periods
The European Commission has issued a proposal to extend the transitional periods for manufacturers to comply with the prerequisites of the EU Medical Device Regulation for some products. Manufacturers should begin to assess whether they may benefit from the changes and which products could profit.
Smart & Biggar | Canada | 15 Feb 2023
Health Canada releases new guidance document on clinical evidence requirements for medical devices
Health Canada released a new guidance document, which provides guidance on clinical evidence requirements for class II, III and IV medical devices. Health Canada also released a companion document, which contains examples of different types of devices and outlines when clinical evidence is more likely or less likely to be required.
Eversheds Sutherland (International) LLP | European Union | 8 Feb 2023
MDCG issues guidance on MDR/IVDR authorised representatives
The Medical Device Coordination Group recently published a guidance document on the relevant requirements of the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation regarding the authorised representative. Due to the prominent role of the authorised representative for manufacturers established outside the European Union, the explanations regarding the new......
Baker McKenzie | USA | 25 Jan 2023
Life sciences licensing from US universities – six areas to consider
Many successful pharmaceutical products and medical devices began as inventions in US university laboratories. Successfully establishing and managing the complex relationships between industry and universities requires appropriately negotiated and drafted licence agreements. This article describes six important considerations for those negotiations and agreements, taking into account the......
K&S Partners | India | 11 Jan 2023
Medical devices and diagnostic inventions in India: patenting trends
🕑 4 minutes The Indian medical devices market is the fourth largest in Asia and among the top 20 globally. As of 2020, the Indian medical devices market was estimated to be worth $12 billion, with an expected compound annual growth rate of 15%. IP laws – primarily those concerning patents – play a crucial role in promoting innovation relating to medical devices. This article, part of a......
Westerberg & Partners Advokatbyrå AB | Sweden | 11 Jan 2023
Another nail in the CBD coffin in Sweden
🕑 4 minutes The Administrative Court of Uppsala has upheld the Swedish Medicinal Products Agency's decision to prohibit a Dutch company from selling cannabidiol (CBD) products for oral consumption on the Swedish market. This decision maintains the strict view in Sweden on CBD products for oral consumption – it may have been the final nail in the coffin for such products on the Swedish market.
