• 2026-10-26 09:52:44

The Food and Drug Administration of the Philippines (PFDA) has circulated a revised draft Circular proposing updated regulatory guidelines for Medical Device Software (MDSW), including AI-enabled MDSW. The draft outlines software qualification criteria, risk-based classification, product authorization pathways, and technical documentation requirements for initial and renewal applications. It also introduces AI-specific requirements covering clinical validation, cybersecurity, risk management, and post-market monitoring. The proposed guidelines aim to strengthen the safety and performance of MDSW throughout its lifecycle. The Circular remains in draft form and is not yet effective.

• 2026-10-26 09:17:04

This FAQ summarizes key regulatory resources and consultation opportunities relevant to the development and regulatory submission of Software as a Medical Device (SaMD) in Japan. The information is intended to support manufacturers in understanding regulatory expectations and planning efficient development and submission strategies throughout the product lifecycle.

• 2026-09-21 02:52:44

In Japan, Software as a Medical Device (SaMD) within certification criteria is reviewed and certified by Registered Certification Bodies (RCBs). Any product that exceeds the definition of its generic name, established certification standards, or the range of equivalence to predicate devices is subject to be reviewed by PMDA for approval.
Recently, it has been discovered that several cases in which the main and additional functions of SaMD products exceeded the certification scope. PMDA published this notice to prevent the recurrence of similar inappropriate certifications by standardizing and clarifying the requirements for describing software functions (Reference 1).

• 2026-08-25 07:11:00

As general-purpose digital devices like smartphones and wearables become increasingly integrated into health monitoring, PMDA published the review guidance for home-use Software as a Medical Device (SaMD) intended to detect signs of disease and encourage users to seek medical consultation. It outlines the scope of the guidance, product description requirements, evaluation dossier, and key considerations for clinical study design, including clinical intention, design concept, clinical performance evaluation, and risk management. The summary is intended to provide an overview of the regulatory expectations for the development and evaluation of this type of SaMD and to facilitate understanding of the PMDA review approach.

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-07-27 02:32:02

The Hong Kong MDD has revised its Guidance Notes (GN-00), effective 13 May 2026. The update introduces Appendix 1, officially classifying injectable dermal and mucous membrane fillers as medical devices under MDACS. Manufacturers, LRPs, and consultants must evaluate this expansion due to immediate compliance and registration requirements.

• 2026-06-26 06:31:01

The FDA's Electronic Medical Device Reporting (eMDR) program requires medical device manufacturers and importers to submit Medical Device Reports (MDRs) electronically for adverse events, malfunctions, and other reportable incidents. The eMDR system improves the efficiency, accuracy, and timeliness of post-market surveillance by enabling electronic submission, processing, and tracking of reports through FDA systems. Manufacturers should establish robust procedures to ensure compliance with eMDR requirements and maintain effective post-market monitoring of device safety and performance.

• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 2026-05-27 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

• 2026-05-27 01:54:19

Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.