Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
March 1, 2025
Approximately 5 minutes
Philippines SaMD Registration: Regulatory Framework and Technical Standards
Software as a Medical Device (SaMD) Registration in the Philippines
The registration of stand-alone Software as a Medical Device (SaMD) in the Philippines is governed by the new regulatory framework, primarily Administrative Order No. 2018-0002. This order specifically includes software in the legal definition of a medical device (Clause IV, Sec. 15), meaning SaMD must undergo the required pre-market approval process through the Center for Device Regulation, Radiation Health and Research (CDRRHR).
Classification and Conformity Assessment
SaMD is subject to a risk-based classification system (Low to High Risk) following the guidance of the ASEAN Medical Devices Directive (AMDD). The classification dictates the required conformity assessment:
- Certificate of Medical Device Notification (CMDN): Required for lower-risk SaMD (e.g., Class A).
- Certificate of Medical Device Registration (CMDR): Required for higher-risk SaMD (e.g., Classes B, C, D).
The intended use of the software determines its classification. For instance, an irregular heart rate monitoring app is typically considered a medical device, while a general fitness or wellness app is not.
Technical Documentation and Compliance Standards
Registration requires comprehensive technical documentation, which must align with international standards specific to software life cycles and safety, in addition to the ASEAN Common Submission Dossier Template (CSDT) requirements.
| Standard | Focus Area |
|---|---|
| IEC 62304:2006 | Software Life Cycle Processes for development and maintenance. |
| IEC 82304-1 | Safety and Security of Health Software (specific for stand-alone SaMD). |
| IEC 60601-1 (Sec. 14) | Applies to embedded software in hardware devices. |
| IEC 81001-5-1 | Health software and health IT system security/cybersecurity requirements. |
| IEC 62366-1 | Usability Engineering (man-machine interface ergonomics). |
The dossier must include standard technical data, Design Validation and Verification Reports, and detailed specifications of the software.
Data Privacy and License Maintenance
- Data Privacy: SaMD manufacturers must ensure compliance with the Data Privacy Act of 2020 (RA 10173), which requires robust protection of user data and adherence to the National Privacy Commission's guidelines.
- Importing: Since SaMD is typically downloaded without physical import, the customs clearance requirements supervised by the local License Holder do not apply unless the software is physically distributed (e.g., on a USB drive).
- License Maintenance: Registrations require payment of an Annual Retention Fee. Approval must be obtained for any changes to the software that affect the original registration, especially updates to the labeling and Instructions For Use (IFU).
Related Articles
Approximately 5 minutes
Philippines Medical Device Registration: CMDN, CMDR, and ASEAN Harmonization
The Philippines FDA (CDRRHR) uses ASEAN-harmonized Class A-D classification and two main approval routes: Certificate of Medical Device Notification (CMDN) for Class A and Certificate of Medical Device Registration (CMDR) for Classes B, C, and D. Home/Reference country approval is generally required.
Approximately 5 minutes
Philippines IVD Device Registration: Transitioning to AMDD Classification and CIVDR/CIVDN
The Philippines FDA (CDRRHR) is transitioning IVD registration to the AMDD risk classification. Registration requires a Certificate of IVD Notification (CIVDN) or Registration (CIVDR), in-country testing for high-risk classes, CSDT documentation, and authentication of legal documents by the Philippine Consulate.
Approximately 5 minutes
Philippines Medical Device Classification: Aligning with ASEAN MDD Risk Rules
The Philippines FDA uses a risk-based classification system (Class A to D) aligned with the ASEAN Medical Device Directive (MDD). Classification determines the required market authorization: CMDN (Notification) for Class A and CMDR (Registration) for Classes B, C, and D.
Approximately 5 minutes
Philippines Medical Device Grouping: Rules for Consolidating Registration Applications
The Philippines FDA uses specific, strict rules for grouping multiple medical devices under a single registration (CMDN/CMDR) to reduce costs and streamline the process. Grouping is permitted for accessories, systems, devices with common intended use/manufacturing processes, and devices with varying materials or designs.
Approximately 5 minutes
Philippines Medical Device Labeling: Compliance with ASEAN MDD and Local Requirements
Medical device labeling in the Philippines is guided by the ASEAN MDD and is subject to FDA review. Labels must be in English and/or Filipino, contain comprehensive product and use details, and reflect the device's market authorization status (CMDN or CMDR).
Approximately 5 minutes
Philippines Medical Device Advertising: Compliance with Consumer Act and ASC Review
Medical device advertising in the Philippines is governed by the Consumer Act (RA 7394) and requires screening by the Ad Standards Council (ASC) to ensure honesty and accuracy. Sales promotions require a separate Sales Promo Permit from the FDA.
Approximately 5 minutes
Philippines Medical Device Post-Market Surveillance: Vigilance and ASEAN Alignment
Philippines FDA's Post-Market Surveillance (PMS) is transitioning towards mandatory adoption of ASEAN Vigilance guidelines (AMDD Annex 5). PMS requires local dealers to maintain traceability records, implement a complaint handling system, and manage Adverse Event (AE) reporting and Field Safety Corrective Actions (FSCA).