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China drafts top-legal level medical device law https://lnkd.in/gwAy56KS    China has been embracing a gradual increase in medical device registrations in recent years, prompting the country’s National Medical Products Administration (NMPA) to step up regulation and launch a public consultation on a draft law.     The draft medical device administrative law covers the different developmental stages, including R&D, manufacturing, distribution and sales.    Charlene Huang at Global Law Office said currently the entire life cycle of medical devices – from R&D, registration, production and operation to its usage – was regulated by various fragmented measures and administrative regulations, and this practice easily created regulatory inconsistencies.    Katherine Wang at Ropes & Gray LLP said the draft law also regulates medical devices imported to China, with the NMPA imposing heavier responsibilities on local legal deputies. It said in the draft that local legal representatives would “bear joint liability with the registrants and filers of imported medical devices”.    Click China Business Law Journal for more information.    👉 Join our membership: https://lnkd.in/gBZGctHN     #cblj #china #compliance #medicaldevice #medical #legaladvice #inhousecounsel #business #legalprofession #lawfirms #lawyers #legal #law #lawdotasia

Last week, China’s National Medical Products Administration released the draft of the Medical Devices Administration Law of the People's Republic of China for public comment with the deadline for feedback set for 28 September 2024.   Find out more here: https://lnkd.in/gHz_5Hpd   If you have any questions, contact Jonathan Chu and Roxie Meng.    #CMSlaw #law #regulatory #lifesciences #healthcare

*Out now in the JMDR Digital Bookstore*: 🏯Interview: Katherine Wang talks to the JMDR about China’s draft ‘Medical Device Administrative Law’ Katherine Wang talks to the JMDR about China’s draft ‘Medical Device Administrative Law’, which was released for public comment on 28 August 2024, and is the first statute of its kind to regulate the research and development, manufacturing, distribution, and use of medical devices in China. Katherine explains what incentives have been proposed to support the launch of new products in China, as well as the greater importance being placed on compliance with China’s compulsory product standards. She also discusses, among other things, the proposal for increased liability of the local legal representative of an overseas marketing authorisation holder.  #medicaldevices #regulatoryaffairs

In public procurement, safeguarding intellectual property rights is crucial to fostering innovation, legality, and fair competition. The Supreme Court of Justice has set precedents requiring public officials involved in procurement to verify the existence of intellectual property rights for goods and services. 💡 “Where public interest is at stake, adherence to the law must prevail as a guiding principle.” #PublicProcurement #IntellectualProperty #Transparency #SupremeCourt #AdministrativeLaw

Shareable Insights by Citeline | 11 October 2024, Part 2 Source: Medtech Insight 𝗖𝗵𝗶𝗻𝗮 𝗠𝗼𝘃𝗲𝘀 𝗙𝗿𝗼𝗺 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗢𝗿𝗱𝗲𝗿𝘀 𝗧𝗼 𝗠𝗲𝗱𝘁𝗲𝗰𝗵 𝗟𝗮𝘄 – 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 𝗨𝗻𝗱𝗲𝗿𝘄𝗮𝘆 𝗪𝗵𝗼 𝘀𝗵𝗼𝘂𝗹𝗱 𝗿𝗲𝗮𝗱 𝘁𝗵𝗶𝘀? Regulatory executives and business development departments within innovative medtechs who need to keep #China in their global market access footprint. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝗶𝘁? Notice of a Chinese Medical Device Administrative Law in 2025, which, after two decades of medical device administrative orders, will put medtech on the same level as pharma. 𝗪𝗵𝘆 𝗶𝘀 𝗶𝘁 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁? Going broader than regulatory – but not touching on volume-based procurement – the law will necessarily change the behaviours of market entrants by introducing broader liability for local Chinese agents; stipulating adherence to standards; and imposing larger penalties for noncompliance. But more favorable reimbursement mechanisms for innovative products and encouraging hospitals to procure them are also proposed. https://lnkd.in/dqrkTa4W

Are International Standards Truly “International”? 🤔 Whilst #InternationalStandards are developed with the aim to ensure safety and quality across borders, the reality is often more nuanced. This is due to: 📝 Diverse Interpretations: Some countries wholeheartedly embrace international standards, while others adapt them to suit their specific needs or regulatory frameworks. This can lead to discrepancies in requirements and expectations. 🗺️Cultural and Regional factors: Cultural differences and regional variations can influence how standards are understood and implemented. For example, different approaches to risk assessment or clinical evaluation may prevail in certain regions. This in turn introduces a wealth of Regulatory Challenges. Ensuring harmonisation and consistency across diverse regulatory landscapes can be a formidable task for any manufacturer making it a huge challenges to overcome for manufacturers looking to scale their innovation. While international standards provide a valuable framework for global medical device regulation, it would be unfair to call them truly ‘international’. Read more in our latest blog here: https://lnkd.in/g795TFVT #JoinThe8fold 

Big Changes Coming to Medical Device Regulations in China! As of November 2024, China is taking a monumental step towards streamlining its medical device registration process with the release of a new Medical Device Administrative Law. This law aims to unify fragmented regulations across the medical device lifecycle, from R&D to commercialization. One key update is the transferability of registration certificates, making it easier for companies to bring high-investment devices to market. This is a game-changer for foreign and domestic manufacturers alike, simplifying the complex approval process and increasing the speed to market. The law also increases accountability, requiring local agents for imported devices to assume joint responsibility for compliance post-approval. With 12,000 devices registered last year and a growing market, it's clear that China is committed to maintaining high safety standards while fostering innovation. #ChinaMedicalDevices #RegulatoryUpdate #MedicalDeviceIndustry #Innovation

𝐌𝐚𝐣𝐨𝐫 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 𝐢𝐧 𝐂𝐡𝐢𝐧𝐚’𝐬 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 The Chinese government is rolling out major reforms in medical device regulations, and the role of China agents is evolving with more responsibilities and stricter oversight. These updates could have a significant impact on your business. In her latest blog, Stephanie H. breaks down the key changes and what they mean for companies entering or operating in China. Stay informed and prepared with expert insights from our team! https://lnkd.in/eFCsxyVa #MedicalDevices #RegulatoryUpdate #ChinaMarket #NMPA #Consultancy #Compliance

Reading the long-awaited CJEU Judgment in Servier yesterday (long awaited by me at least, as I've been involved in this matter since 2010...) I was struck by this paragraph. 384    It follows from those considerations that the assessment of the substitutability of two products is not limited to determining whether those products are, from a functional point of view, capable of satisfying the same need, but also requires a determination as to whether, from an economic point of view, those products are in fact substitutable. Economic substitutability between two products may be found where changes in their relative prices lead to a shift in the sales of one to the other. In that regard, it must be pointed out that, as is apparent from paragraph 13 of the Notice on market definition, referred to in paragraph 2 of this judgment and to which the General Court made reference in paragraph 1384 of the judgment under appeal, from an economic point of view, demand substitutability constitutes the most immediate and effective disciplinary constraint on the suppliers of a given product. The assessment of that substitutability consists essentially in assessing the cross-price elasticity of demand by determining whether consumers of a product subject to a small but permanent price increase would switch to substitute products." Hopefully this will start to move the Commission (and other NCAs) away from the excessive reliance on functional characteristics that I have observed in recent cases. https://lnkd.in/etpWq9yU

#BusinessLawToday | From medical devices that operate using AI to groundbreaking therapies, life sciences diligence needs deep IP knowledge—especially for patent and FDA risks. Read: https://ow.ly/KIPU50Uvkah #BusinessRegulation #RegulatedIndustries #MergersandAcquisitions #BusinessLaw Brian Moriarty Hamilton, Brook, Smith & Reynolds, P.C., Eric Balicky, Lawrence Cogswell, Ph.D.