Grouping in the Philippines is stricter than many of the other regional markets as one STED file could lead to multiple registrations. In order to be grouped together, the products will need to adhere to following rules:
A medical device and accessories that can be sold separately;
Medical devices that are owned by the same manufacturer and distributed at the same time, but made in different manufacturing plants;
Medical devices that are meant to be used in combination as a system;
Medical devices with a common intended use and manufacturing process but have different materials and/or designs;
Medical devices with the same materials but have variations and a different intended use;
Contact Asia Actual for more information about the Philippines grouping requirements.
Guidance Document Name
Ministerial Regulations, Medical Device Products required Listing Approval
Outlines classification criteria for a Class 1, Listing category.