The Thai FDA recently released new grouping guidance for medical devices. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. To be grouped together, the products will need to adhere to the specific rules to belong to certain categories.
The different grouping categories are as follows:
IVD Test Kit
Additionally, three general rules of grouping apply to each category:
One generic proprietary name
One product owner
One common intended purpose
Definitions and Examples
A Single device complies with the three general rules, and ranges in package size and/or number of units.
A System follows the three general rules and contains accessories that work in combination with the medical device to acheive a common intended purpose. The label, user manual, and brochure/catalog must all denote the same purpose as well.
A Family consists of products that comply with the three general rules and have a common risk classification, design, and manufacturing process but may slightly differ from each other. Permissible variants can be found below.
Permissible Variants for Family
Coating material for lubrication only
Diameter, Length, Width, Gauge
Concentration with same indication and mechanism (same composition different amount of constituent
Dimensional design differences due to pediatric versus adult use (The differences due to the different patient population are permissible, e.g., volume and length)
Isotope activity level
Method of sterilization (to achieve same sterility outcome)
Shape, size, and volume
Viscosity (The change in viscosity is solely due to changes in the concentration of the constituent material)
Type of device mounting (e.g., ceiling mount, wall mount, or standing)
Sterility status (sterile vs. non-sterile)
Retention (e.g., cement or screws)
Active Implantable Devices
MR Conditional and Non-MR Conditional
Antibiotic Test (IVD)
Formable or Non-Formable
i) Anticoagulants with the same composition but different concentrations
ii) Additives (different composition and concentrations)
i) Number of lumens in catheter
ii) Material of catheter: PVC (polyvinylchloride), PU (polyurethane), nylon, and silicone
Different formats (e.g., solution, creams, gels loaded onto pads, etc.)
A Set consists of 2 types of medical devices that complies with the three general rules and are imported and sold in the same packaging. Risk classification will be based on the device with the highest risk.
IVD Test Kits comply with the three general rules and are labelled as an IVD test kit. These kits do not include analyzers.
And IVD Cluster complies with the three general rules and are manufactured by a common entity, either Type 1 or Type 2 risk, and have a common methodology. For example, it may contain two different test kits, reagents, and other articles.
Contact Asia Actual for more information about Thailand grouping requirements.