Home About Qualtech NEWS THAILAND: Announcement of the Food and Drug Administration Regarding Criteria for Grouping Medical Devices – January 2019
THAILAND: Announcement of the Food and Drug Administration Regarding Criteria for Grouping Medical Devices – January 2019

January 15, 2019

The Secretary-General of the ThaiLand Food and Drug Administration has issued the criteria for grouping medical devices. This has been in effect starting from October 2018, by virtue of the definition in Section IV of the Medical Device Act 2008. It is advisable to set the criteria for grouping medical devices in order to effectively control medical devices, in accordance with the control of medical devices in regional and Asian systems. The notification are as follows:

(1) The grouping of medical devices is classified into six categories as follows: 

(a) Single means medical device from manufacturer which is classified by Medical Device property name or Brand name with specific intended purpose which may come in various sizes and having different packaging.

(b) System means: (note: Any medical device that is categorized into the grouping of SYSTEM shall meet all requirements from 1b to 4b.)

(1b) Medical device from the same manufacturer or have multiple manufacturing sources but must be under the same manufacturer;

(2b) Medical device must be indicated to function together to achieve the identical objectives as intended;

(3b) Medical device components must function together to achieve the identical objectives as intended;

(4b) Medical devicemust be sold under the name of System, where the labelling, catalogue of each components must specify the message of “Intended purpose for the System).

(c) Family means: (note: Any medical device that is categorized into the grouping of FAMILY shall meet all requirements from 1c to 6c).

(1c) Medical device from the same manufacturer or have multiple manufacturing sources but must be under the same manufacturer;

(2c) Medical device must have identical level of risk control;

(3c) the name of each medical device in Family must be under identical Medical Device Proprietary Name or Brand Name;

(4c) Medical Device must have identical intended purpose;

(5c) Medical device must have identical or very similar physical design, structure and manufacturing procedure;

(6c) the main components of each medical device in Family can be different but must be under the scope of permissible variants with identical risk management information. Therefore must be correspond to (4c) and (5c).

(d) Set means consisting of 2 or more medical devices that are packed in the same packing : (note: Any medical device that is categorized into the grouping of SET shall meet all requirements from 1d to 3d)

(1d) the name of SET medical device must be under identical Medical device propriety name or Brand name, which may have additional explanation;

(2d) Medical device must be indicated to function together to achieve the identical objectives as intended;

(3d) Medical device risk control must be classified according the highest medical device risk of that particular medical device SET.

(e) IVD Test Kit means: (note: Any medical device that is categorized into the grouping of IVD Test Kit shall meet all requirements from 1e to 4e)

(1e) must have same manufacturer or have multiple manufacturing sources but must be under the same manufacturer;

(2e) must have identical intended purpose;

(3e) must be sold under the name of IVD TEST KIT. Labelling, catalogue and documents of each component must specify the message “Objectives for the use of IVD TEST KIT only”;

(4e) must function together to achieve the identical objectives as intended.

(f)     IVD Cluster means: (note: Any medical device that is categorized into the grouping of IVD Cluster shall meet all requirements from 1f to 3f)

(1f) have identical manufacturer;

(2f) have level 1 or 2 of the medical device risk control;

(3f) have identical Methodology and classified in the Cluster.

(2) To be used as a practical guideline for medical device control of Food and Drug Administration’s staff and related parties in accepting requests and considering evaluating, certifying medical devices produced or imported before selling medical device bundles in the same request.

(3) In case of any requirement of medical device grouping diagnosis, the Secretary-General of the Food and Drug Administration or the person entrusted is authorized to decide on the classification of medical device.

 

Reference:

Official press

 

 

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Home About Qualtech NEWS THAILAND: Announcement of the Food and Drug Administration Regarding Criteria for Grouping Medical Devices – January 2019