Wrapping up January 2025, medical device regulatory developments include new forms for NBs in Europe, new PMS guidance in the UK, an expedited approval partnership between China and Malaysia, and warnings of supply chain disruptions for pediatric patients in the US.
The EU Commission has released revised versions of the Preliminary Assessment Review (PAR) templates and related application forms for designation as a Notified Body, including the MDCG 2024-7 rev.1 (MDR) and MDCG 2024-8 rev.1 (IVDR) templates, alongside their corresponding annexes. The updated documents remove section G.4, streamlining the application process. These revised templates should now be used to prepare and submit documents when applying to a Notified Body. Access the updated files and more information via the official EU Health website.
For additional guidance, visit the EU Health page on MDCG Documents.
Learn more about EU Medical Device Registration.
The UK MHRA has released detailed guidance on implementing the new PMS requirements under The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Following the publication of Statutory Instrument (SI) 2024/1368 on December 26, 2024, the guidance outlines PMS obligations, which align closely with ISO 13485 and EU MDR/IVDR standards.
Manufacturers must establish a PMS system that includes a PMS procedure, a PMS Plan, and linked preventive and corrective actions within the risk management process. PMS data must be documented in a PMS Report (PMSR) or Periodic Safety Update Report (PSUR), with the latest report made available to MHRA within 3 working days upon request. These requirements will apply across England, Scotland, and Wales starting mid-2025.
Learn more about MHRA UK Medical Device Registration & Approval.
The U.S. FDA has issued an urgent overview addressing the growing vulnerabilities in the medical device supply chain, emphasizing their significant impact on public health, particularly for neonatal and pediatric patients. Shortages of critical devices, such as ventilators, neonatal breathing tubes, and hemodialysis catheters, threaten care for the most vulnerable populations, including newborns and children with severe health conditions.
While supply chain challenges are not new, the FDA warns of a worsening crisis with adverse outcomes, especially for these at-risk groups. In its review, the FDA also references the EU's newly implemented mandatory notification rule for medical device shortages (effective January 10, 2025), which provides critical information to EU member states and the European Commission. The FDA calls for similar mandatory reporting requirements in the U.S. to proactively identify and mitigate medical device shortages and safeguard patient care.
Learn more about FDA US Medical Device Registration.
On January 14, 2025, Malaysia’s Medical Device Authority (MDA) and China’s National Medical Products Administration (NMPA) announced a transformative agreement to jointly approve medical devices, significantly reducing regulatory timelines.
Under this new framework:
This streamlined process replaces the older system, which required separate approvals taking up to two years. The agreement reflects trade patterns, as Malaysia imports high-end Class C/D devices from China, while most Malaysian exports to China are Class B devices.
Regional Integration and Benefits
Malaysia is also expanding its reference agencies to include ASEAN regulators, complementing existing partnerships with bodies like the FDA (USA), TGA (Australia), and others, further accelerating approvals for Class B/C/D devices.
This collaboration is expected to boost trade significantly. Malaysia, already a top buyer of Chinese medical devices, will see increased market penetration by Chinese manufacturers. Simultaneously, Malaysian exports to China, valued at MYR58 million in October 2024, are poised to grow.
Seizing Opportunities
This joint framework is set to foster innovation and expand market access for manufacturers and distributors. According to a 2024 Deloitte report, Malaysia is already a top importer of Chinese high-end medical devices, and the trend is expected to accelerate under the new agreement.
Learn more about China Medical Device Registration & Approval and MDA Malaysia Medical Device Registration.
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Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.
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As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
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.
