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.
February 1, 2025
Approximately 5 minutes
Philippines Medical Device Grouping: Rules for Consolidating Registration Applications
Philippines Medical Device Grouping Guidelines
The Philippines Food and Drug Administration (FDA), through the Center for Device Regulation, Radiation Health and Research (CDRRHR), provides specific rules for grouping multiple medical devices under a single application for a Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR). These rules are often considered stricter than those in other ASEAN markets, as a single technical file (STED) may sometimes lead to multiple required registrations if the grouping criteria are not perfectly met.
📋 Rules for Grouping Devices
To be included together in a single registration application, medical devices must adhere to the following permitted grouping scenarios:
- Device and Separately Sold Accessories:
- A primary medical device and its associated accessories that can be sold separately.
- System/Procedure Packs:
- Medical devices that are meant to be used in combination as a system (e.g., a monitoring unit and its specific, required sensors).
- Same Manufacturer, Different Plants:
- Devices that are owned by the same manufacturer and distributed at the same time, but are produced in different manufacturing plants.
- Common Use/Process, Different Design/Material:
- Devices with a common intended use and common manufacturing process but which have variations in their materials and/or designs.
- Same Material, Different Variation/Use:
- Devices with the same materials but which have variations or a different intended use.
📝 Strategic Importance of Grouping
A clear and structured grouping framework, as recently proposed by the FDA, aims to:
- Streamline Registration: By allowing manufacturers to submit a consolidated dossier for related products.
- Reduce Costs: Minimizing the total number of applications and associated application fees required for market authorization.
- Align with ASEAN Standards: Ensuring regulatory consistency with regional partners.
Manufacturers must carefully assess their product portfolio against these strict rules to maximize the efficiency of the registration process in the Philippines.
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 SaMD Registration: Regulatory Framework and Technical Standards
The Philippines FDA explicitly defines Software as a Medical Device (SaMD) under AO 2018-0002, requiring risk-based registration (CMDN/CMDR). Technical documentation must comply with international standards (e.g., IEC 62304), and data privacy laws (RA 10173) must also be observed.
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).