What’s the criteria followed by Thai FDA for group classification of medical devices in Thailand?
We receive often requests to register bundles of medical devices that may considered as group, family or set, according to classification of medical devices in Thailand
The important point is that THAI FDA DECIDES HOW TO CLASSIFY GROUP OF MEDICAL DEVICES, according to the note issued by Thai FDA on October 26th 2561 (2018) named Criteria for group classification of medical devices.
Medical device bundles can be grouped in 6 different ways: SINGLE, SYSTEM, FAMILY, SET, IVD, TEST KIT and IVD CLUSTER, which can be submitted using the same request, in only one license. The details of each medical device group are listed below.
1. Single medical device (SINGLE)
Single medical device (SINGLE) means a medical device from a manufacturer that has been classified by product name (Medical device proprietary name) or trade name (Brand name) with a specific purpose for specific intended purpose, which may be of various sizes and in different styles of packaging containers. Example: a condom with same name but with multiple colors/size.
2. Systematic medical device (SYSTEM)
Systematic medical device grouping (SYSTEM) consists of parts or components having the following characteristics:
(1) manufactured by the same manufacturer or manufactured by multiple sources, but must be under the same owner of the product (owner=marketing authorized holder)
(2) all the devices in the system are intended to work together to achieve the same purpose
(3) the individual components can work together to achieve the same purpose of use according to the declared intended use of the system
(4) must be sold under the name of the system (SYSTEM) in the label, documentation, brochures or catalog of each component Must specify “It is intended to be used as system (SYSTEM)”
Example: a portable hyperbaric chamber with its separate compressor is a system.
3. Family Medical Device (FAMILY)
This is the most common case. In the family (FAMILY) model, each medical device system that is brought together must have the following characteristics:
(1) produced by the same producer or produced by multiple sources; but must be under the same owner of the product (owner=marketing authorized holder)
(2) must have the same level of control of the medical device under the same risks classification
(3) all devices having the same objectives as intended
(4) having the same or similar design and manufacturing process
(5) its variants must be included in the list we enlist at the and of this article.
Example: sampling swabs under same brand but with different sizes and gauges are a family of medical devices.
4. Set of medical devices (SET)
A SET medical device grouping (SET) consists of two or more medical devices packaged in the same packaging with following specifications:
(1) The name of the medical device set (SET) must be under the same medical device proprietary name or brand name, which may have additional descriptive text.
(2) there is an indication stating that the devices in the set work together to achieve the same objectives as intended
(3) They must have same Classification of medical devices and same risks level
Each medical device listed in the Medical Device Set (SET) category may have its product name (Medical device proprietary name), brand name, purpose of use, design or different production processes Each individual medical device set (SET) item can be manufactured by multiple sources.
5. IVD TEST KIT Medical Devices
IVD TEST KIT diagnostic kit is a laboratory test kit for In vitro diagnostic (IVD) device consisting of reagents and materials with the following characteristics:
(1) produced by the same producer or produced by multiple sources; but must be under the same product owner (Marketing Authorized Holder)
(2) there is an indication to enable them to work together to achieve the same objectives as intended;
(3) Must be sold under the name of IVD TEST KIT in the label, medical device documentation, brochure or catalog of each component. Must specify “It is intended to be used as IVD TEST KIT.”
(4) can be used together appropriately. to achieve the same purpose of use as intended
6. IVD CLUSTER medical devices
IVD CLUSTER medical device grouping consists of reagents and materials. with following specifications:
(1) produced by the same manufacturer;
(2) having a level of control of the medical device according to the risk in type 1 or 2 classification
(3) using a test method; (Methodology) and classified in the same CLUSTER category.
IVD CLUSTER medical device group may include analytical instruments Laboratory (Analyzer) designed to be used with IVD CLUSTER reagents.
classification of medical devices in Thailand: permissible variants in FAMILY
This below is the list of admissible variants of all medical devices.
- 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 paediatric versus adult use (The differences due to the different patient population are permissible, eg volume and length).
- Holding force
- Isotope activity level
- Memory storage
- Method of Sterilisation (to achieve same sterility outcome)
- Printing capability
- Shape, Size, Volume
- Viscosity (The change in viscosity is solely due to changes in the concentration of constituent material)
- Type of device mounting (eg ceiling mount, wall mount or standing)
- Sterility status (sterile vs non-sterile)