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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:
Additionally, three general rules of grouping apply to each category:
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 achieve 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 |
Color |
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) |
Flexibility |
Holding force |
Isotope activity level |
Memory storage |
Method of sterilization (to achieve same sterility outcome) |
Printing capability |
Radiopacity |
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) |
Specific Products | Permissible Variants |
Abutments | Retention (e.g., cement or screws) |
Active Implantable Devices | MR Conditional and Non-MR Conditional |
Antibiotic Test (IVD) | Concentration |
Biopsy Forceps | Formable or Non-Formable |
Blood Bags | i) Anticoagulants with the same composition but different concentrations
ii) Additives (different composition and concentrations) |
Catheter | i) Number of lumens in catheter
ii) Material of catheter: PVC (polyvinylchloride), PU (polyurethane), nylon, and silicone iii) Curvature iv) Coating material for lubrication |
Condoms | i) Texture
ii) Flavor |
Contact Lens | i) Diopter
ii) UV protection iii) Tinting iv) Color v) Wearing schedule (i.e., daily wear, extended wear) vi) Replacement schedule (i.e., daily, weekly, monthly) |
Defibrillators | Automatic or semi-automatic |
Dental Brackets | Material of bracket |
Dental Handpieces | i) Rotational speed
ii) Material of handpiece |
Dermal Fillers | Same composition but different concentrations/densities |
Diagnostic Radiographic Systems | i) Number of slices
ii) Digital vs. Analog iii) Biplane vs. Single plane iv) Flat Panel vs. Cassette v) PET ring size |
Electrophysiological Catheter | i) Electrode Spacing
ii) Number of electrodes |
Gloves | Powered or powder-free |
Gamma Camera | Number of detectors |
Guide Wire | With or without inert coating material |
Orthopedic/ Dental Implants | i) Cemented or non-cemented fixation
ii) Collar |
Intra-ocular Lens | i) Monofocal or Multifocal
ii) Multi-piece or Single-piece iii) Aspheric or Spheric |
Implantable Pulse Generators | Number of Chambers (Cardio) |
IV Cannula | i) Presence of injection port
ii) Presence of safety wing |
IVD Rapid Tests | Different assembly format: cassette, midstream, strip |
IVD Urinalysis Strips | Different combination of testing configurations |
Polymer Products | With or without plasticizers (e.g., DEHP) |
Stent | i) Delivery system, that is over the wire or through the scope
ii) Flaps, Flares, or sleeves |
Suture | i) Number of strands
ii) Pledgets iii) Loops iv) Dyes |
Suture passer | Design of jaw, handle, or needle |
Tracheal Tube (endotracheal tube, tracheostomy tube, etc.) | With or without cuff |
Would Dressings | Different formats (e.g., solution, creams, gels loaded onto pads, etc.) |
X-ray Detector | Scintillator material |
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.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Thailand@asiaactual.com
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