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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.
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