This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.
On November 1, 2024, updated regulations under the Human Research Act officially come into force, following approval by the Federal Council in June. These adjustments aim to enhance participant protections and improve conditions for researchers. Provisions regarding transparency will be enacted later, on March 1, 2025. For details on submitting clinical trial applications to Swissmedic under the new ordinance, visit the linked page, which will be regularly updated with practical guidance.
Learn more about Switzerland Medical Device Registration.
On November 1, 2024, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan released a revised Q&A guide on the registration process for medical devices in Taiwan and Japan. This update follows discussions at the 12th Japan-Taiwan Pharmaceutical Exchange Conference, held on October 7 in Tokyo, focusing on regulatory cooperation and improvements in access to pharmaceuticals and medical devices across East Asia. The revised Q&A aims to clarify registration requirements and foster smoother regulatory processes for stakeholders in both countries.
Learn more about PMDA Japan Medical Device Registration.
The National Medical Products Administration is seeking public comments on the draft 2024 Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials. Relevant stakeholders are encouraged to review the proposed updates and submit feedback by December 3, 2024. This initiative aims to enhance regulatory efficiency and support innovation in diagnostic technology. Full details, including the draft catalogue and feedback form, are available on the official website.
Learn more about China Medical Device Registration & Approval.
On November 5, 2024, Cofepris Commissioner Armida Zúñiga Estrada announced that Cofepris will oversee the quality, safety, and effectiveness of medicines, vaccines, and medical devices under Mexico’s new health supply acquisition model. Through streamlined regulatory processes, the agency aims to meet the Health Sector’s 2024-2030 goals by ensuring that public clinics and hospitals have access to safe, high-quality supplies, supporting universal vaccination, and modernizing healthcare facilities across Mexico.
Learn more about COFEPRIS Mexico Medical Device Registration.
The Health Products Regulatory Authority (HPRA) has published the results of the public consultation on the proposed 2025 fees for Human Medicines, Medical Devices, Compliance, and Veterinary Medicines, which closed on 30 October 2024. We extend our gratitude to all participants. The document summarizing the consultation outcomes is now available for review.
The UK’s Innovative Licensing and Access Pathway (ILAP) is set to relaunch in March 2025, with a refined structure aimed at bringing life-changing medicines to patients faster. The updated ILAP will offer an integrated platform, streamlining collaboration between developers, the MHRA, NHS, and UK health technology bodies. Key enhancements include more selective entry criteria, NHS partnership involvement, and simplified guidance to accelerate access to transformative treatments. Full details, including the new eligibility criteria and application guidance, will be published in January 2025.
Learn more about MHRA UK Medical Device Registration & Approval.
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IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.