Memo
Re Import of Beauty Equipment under Medical Device Act BE 2551.
To Khun MM
From T
Date May 30, 2008
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Reference is made to your instruction regarding laws and regulations that might control the import of Our Client's Beauty Equipment.
The relevant laws is Medical Device Act BE 2551 as attached hereto, in which the definition of medical device in section 4 is prescribed broadly to cover all device used in public health profession. However not all medical devices are restricted on importing. Section 6(1) stipulate that the Ministry of Public Health vest with the power to prescribe what type of medical device require license before importing, also in section 6(2) the Ministry may prescribe types of medical device that require the submission of details before importing.
Under section 6(1), Medical device that required license before importing are Condom, Examination glove, Surgical glove, Sterile hypodermic, Syringes for single use, Sterile single use Syringes for insulin, HIV test kit for diagnostic use. All of which seem to have nothing to do with our Beauty Equipment.
Under section 6(2), 19 and notification of the Ministry of Public Health (No. 19) regarding medical device relating to physiotherapy, any medical device that fall within the following category require the issuance of receipt by Thailand Food and Drug Administration (“FDA”) to evidence that the importer has submit details of said device to FDA before importing.
1 Machine or equipment that offer treatment by superficial heat which are
1.1 paraffin wax unit
1.2 hot pack, hydrocollator pack
1.3 electric heating pad
1.4 steam bath cabinet
1.5 moist air heat therapy unit
2 Machine or equipment that offer treatment by cryotherapy which are
2.1 cold pack
2.2 controller cold compression unit
3 Machine or equipment that offer treatment by hydrotherapy
4 Machine or equipment that offer treatment by direct electric current which are
4.1 galvanic or direct current
4.2 interrupted direct current
5 Machine or equipment that offer treatment by electric current with frequency lower that 2000 Hz which are
5.1 sinusoidal current
5.2 diadynaminc current
5.3 faradic current
5.4 high voltage current
5.5 transcutaneus electrical nerve stimulation – TENS
6 Machine or equipment that offer treatment by electric current with frequency between 2000-6000 Hz which are
6.1 Machine or equipment that offer treatment by interferential current
6.2 Machine or equipment that offer treatment by russian current
7 Machine or equipment that offer treatment by electric wave or electromagnetic wave with frequency more that 6000 Hz which are
7.1 Machine or equipment that offer treatment by shortwave diathermy
7.2 Machine or equipment that offer treatment by microwave diathermy
8 Machine or equipment that offer treatment by static current
9 Machine or equipment that offer treatment magnetotherapy
10 Machine or equipment that offer treatment by non-ionized radiation therapy) which are
10.1 Machine or equipment that offer treatment by ultraviolet
10.2 Machine or equipment that offer treatment by infrared
10.3 Machine or equipment that offer treatment by low power laser
11 Machine or equipment that offer treatment by mechanotherapy which are
11.1 massager
11.2 vibrator
11.3 pressure-applying Machine
11.4 electric traction machine
11.5 ultrasound
12 Machine or equipment that offer treatment by exercises therapy
If the Our client's Beauty Equipment is considered as any of the above machine of equipment, the importer must submit details with FDA before importing, otherwise such importer is subject to imprisonment not exceeding 1 year or fine not exceeding one hundred thousand or both according to section 87 of Medical Act BE 2551. In case that the importer is uncertain whether his device require submission of details or not, he could sending letter to FDA seeking for written confirmation.
Please be kindly informed.
TWS
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