This week in global device regulatory news, Singapore’s HSA kicked off a pilot Change Management Program for SaMD, began Phase 2 UDI labelling for Class D devices, and issued joint clinical-trial principles for machine-learning devices with Korea; Brazil’s Anvisa published a draft user manual for its forthcoming UDI database; and Turkey’s TITCK mandated six-month supply-interruption notices while tightening ÜTS registration for IVDs re-classified under the IVDR.
The Health Sciences Authority (HSA) is launching a pilot run of the Change Management Program (CMP) for Software as a Medical Device (SaMD), including machine learning-enabled SaMD, as part of our ongoing efforts to enhance regulatory efficiency. This new optional pathway integrates with existing premarket product registration and change notification processes and introduces the concept of pre-specified changes. The pilot will commence on 4 December 2024. Stakeholders who wish to participate must complete a 2-step enrollment process via MEDICS and email notification. Updated guidance, refined through stakeholder consultation, is now available in GN-37-R1.
As part of Singapore’s ongoing commitment to enhance patient safety and traceability of medical devices, the Health Sciences Authority (HSA) has commenced Phase 2 of the Medical Device Unique Device Identifier (UDI) System implementation.
Effective 1 November 2024, all Class D medical devices—including general medical devices and in vitro diagnostic (IVD) devices—must be labelled with a UDI before they can be supplied in Singapore. All Class D device registrations have successfully submitted their UDI information to the Singapore Medical Device Register (SMDR).
The UDI system will be progressively extended to Class C and B devices in subsequent phases. For comprehensive guidance, refer to GN-36: Guidance on Medical Device UDI System.
To advance the safe and effective development of machine learning-enabled medical devices (MLMDs), the Health Sciences Authority (HSA) and Korea’s Ministry of Food and Drug Safety (MFDS) have jointly released a set of guiding principles for conducting clinical trials involving MLMDs.
These principles aim to address the unique challenges posed by MLMDs in clinical research, such as algorithm adaptability and data variability. By providing a harmonised regulatory approach, HSA and MFDS seek to support innovation in digital health technologies, while ensuring that MLMDs meet high standards of safety, performance, and clinical relevance.
This collaboration marks a significant step in fostering regulatory alignment and supporting the growth of AI-driven healthcare solutions.
Learn more about HSA Singapore Medical Device Registration.
Anvisa has published a preliminary version of the user manual for the Unique Device Identification (UDI) database, a key step in aligning Brazil with international standards set by the International Medical Device Regulators Forum (IMDRF). The UDI system aims to improve the traceability, safety, and regulation of medical devices in the Brazilian market by enabling standardized identification.
This manual provides detailed guidance on the features of the UDI database that have already been developed, while clarifying that further instructions will follow as remaining functionalities are completed. The database is being developed under Anvisa’s Strategic Plan (2024–2027) and will be officially launched once the normative instruction—currently under Public Consultation 1,313/2025—is finalized and enacted.
The final implementation will follow the timeline set in RDC 591/2021, with mandatory UDI submissions required in phases based on device classification, starting with Class IV devices. Stakeholders are encouraged to review the proposed rules and submit comments by May 26, 2025, via the official consultation portals.
Learn more about ANVISA Brazil Medical Device Registration.
The Turkish Medicines and Medical Devices Agency (TITCK) now mandates that manufacturers, authorized representatives, and importers must notify authorities at least 6 months in advance of any foreseeable interruption or cessation of supply of medical devices or in vitro diagnostic (IVD) products that could pose serious risks to public health. This aligns with recent amendments to the EU MDR/IVDR regulations. Global market players should act promptly to ensure compliance and avoid market disruption. Learn how we can support your regulatory obligations in Turkey.
The Turkish Medicines and Medical Devices Agency (TITCK) has issued new guidance on the ÜTS (Product Tracking System) registration process for in vitro diagnostic (IVD) products transitioning to higher risk classes under the EU-aligned IVDR (2017/746). Manufacturers must update product records with a mandatory classification declaration by June 30, 2025, for currently registered IVD-Other class devices. Products being registered or updated for the first time must also include this declaration. Additionally, deadlines have been set for submitting IVDD-to-IVDR transition applications based on device risk class. Non-compliant applications will be rejected.
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