09 April 2020
DEFINITION OF MEDICAL DEVICE THAT MANUFACTURER AND IMPORTER MUST PROCEED MEDICAL DEVICE TO BE NOTIFIED REGISTRATION 2020
By virtue of section 5 paragraph one of section 6 (1) (b) of the Medical Device Act B.E. 2551, as amended by the Medical Device Act (No. 2) B.E. 2562, section6 (4) (5) and (13) of the Medical Device Act B.E. 2551, Article 44, paragraph two of the Act Medical Devices B.E. 2551, as amended by the Medical Devices Act (No.2) B.E. 2562 and section 45 paragraph two of the Medical Device Act B.E. 2551. The Minister of Public Health, with the recommendations of the Medical Device Committee, announced as follows:
1. All medical devices included in Attachment 1, manufacturer and importer must proceed medical device to be Notified registration. The standard of the medical device must comply with the requirements stated in Attachment 1 accordingly.
2. Manufacturer and importer must prepare labelling that comply with the requirements stated in Attachment 2 accordingly.
3. Manufacturer and importer must prepare medical device document that comply with the requirements stated in Attachment 2 accordingly.
4. Importer of the medical devices in this Announcement must prepare labelling and medical device document accordingly to (2) and (3) in prior of marketing the products. This action must be completed within 30 days after custom clearance.
5. Medical Devices to be Licensed applications of Ministry of Public Health Announcement Medical Device to be Notified Registration (No.19) 1996 regarding Therapeutic Device 1996 that submitted on the day before the date of this Announcement implementation is considered to be evaluated under this Announcement accordingly.
6. Import Permit of Medical Devices to be Notified issued before the implementation of this Announcement is still valid until its expiry date.
- This decree shall come into force after 30 days from the date of its publication in Government Gazette.
Translated from official ThaiFDA announcement, by:
Attachment 1. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Notified Registration 2020
Medical Device Group include:
Therapeutic Medical Device as follow:
1. Superficial heat
(1) Powered heating pad or electric heating pad.
(2) Steam bath cabinet
(3) Moist air heat therapy unit
2. Controller cols compression unit
3. Hydrotherapy or immersion hydrobath
(1) Galvanic or direct current
(2) Interrupted direct current
5. Electrotherapy unit under 2,000 Hz
(1) Sinusoidal current
(2) Diadynamic current
(3) Faradic current
(4) High voltage current
(5) Transcutaneous electrical nerve stimulation-TENS
6. Electrotherapy unit between 2,000-6,000 Hz
(1) Interferential current
(2) Russian current
7. Electrotherapy unit over 6,000 Hz
(1) Shortwave diathermy
(2) Microwave diathermy
8. Static current therapy unit
10. Non-ionized radiation therapy
(1) Ultraviolet therapy unit
(2) Infrared therapy unit
(3) Low power laser therapy unit
Attachment 2. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be