Ministry of Public Health has introduced a new guidance document regarding labelling of medical devices to be registered and sold in Thailand. This is to ensure consumers safety, as well as distributing accurate and sufficient medical device information.
It is noted in this guidance document that all Establishment Importer Licensee, Licensed Medical Device Licensee, Notified Medical Device Licensee or General Medical Device Licensee whom manufacture/import medical device must be able to provide clear labelling and medical device documents, for both home use and professional use medical devices. Home use medical device shall be prepared in both Thai and English languages, but just English is sufficient for professional use medical devices.
For more details on the requirements of labels, please refer to the official guidance document. The official document has been translated by Qualtech, from Thai language to English, as following:
5 November 2020
MINISTRY OF PUBLIC HEALTH ANNOUNCEMENT
LABELLING AND MEDICAL DEVICE DOCUMENT 2020
1. Definitions:
“Home use medical device” means medical device aiming to be use by lay users at places that the environment is not a medical facility such as home or a medical device that medical personnel advised patient (human and animal) outside of a medical facility. It also includes medical device that is tended to be used both inside and outside the medical facility.
“Professional use medical device” means medical device aiming to be used for medical and public health practitioners or under professional practitioners/medical and public health practitioner’s supervision only.
2. Establishment Importer Licensee, Licensed Medical Device Licensee, Notified Medical Device Licensee or General Medical Device Licensee whom manufacture/import medical device must provide a clear labelling and medical device document as required in Clause.3 or Cluase.4 and shall not be misled, and over exaggerated.
3. Licensed Medical Device Licensee, Notified Medical Device Licensee or General Medical Device Licensee must prepare labelling of medical device as follow:
(1) Home use medical device, shall be prepared in Thai.
(3) Labelling shall be clearly display on medical device or packaging with required details as follow:
(a) Medical device name
(b) Medical device description. E.g. composition, mechanism, type
(c) Intended use or indication
(d) Quantity
(e) Instruction for use
(f) Name and address of manufacturing site/ importer. In case of Importer, it is required to specify
name, city, and country of manufacturing site, if it is impossible to display name and city of
manufacturing site, then name, city, and country of product owner; and country of manufacturing
site shall be display instead.
(g) Registration No. of Licensed Medical Device; Notified Medical Device; General Medical Device.
(h) Name, address, phone number or others. In case of contact purpose, complaint, or information
inquiry.
(i) Numbers or alphabets indicating manufacturing LOT or serial number
(j) M/Y or Y/M of expiration date. Year shall be display with 4 digits number. In case of medical
device with expiration date, it is required to display M/Y and Y/M of expiration date.
(k) Storage condition
(l) Warning, Prohibition, Precaution (If any)
If it is impossible to display (c), (e), (h), (k) and (l) on labelling, then shall be display in medical device
document instead.
Home use medical device labelling (i) can be prepared in English or in English abbreviation format.
Professional use medical device labelling (i) and (j) can be prepared in English or in English abbreviation format.
When labelling details are in abbreviation format then it is mandatory to include its definition in medical device labelling or medical device document.
4. Home use medical device shall be prepared in both Thai and English. Display of other languages are optional. Labelling shall be clearly display on medical device or packaging with required details as follow:
(1) Medical device name
(2) Medical device description. E.g. composition, mechanism, type
(3) Intended use
(4) Quantity
(5) Name and address of manufacturing site/ importer. In case of Importer, it is required to specify
name, city, and country of manufacturing site, if it is impossible to display name and city of
manufacturing site, then name, city, and country of product owner; and country of manufacturing
site shall be display instead.
(6) Indication; Instruction for use
(7) Storage condition
(8) Warning; Prohibition; Precaution (If any)
(9) Update of latest date of any amendment or Control Mo. of medical device document.
When labelling (5) and (7) are already being displayed in labelling there is no need to display the following details in medical device document.
When labelling (1) to (8) are already being displayed in labelling then medical device preparation shall be exempted.
It is required for “Professional use medical device” to have an English medical device document.
5. Medical device preparation accordingly to Clause.3 can be in the format as follow: electronic (e.g. CD, QR code, website) in order for all parties to easily access medical device information.
6. List of medical devices which are exempted to prepare labelling and medical device document accordingly Clause.3 and Clause.4 of this announcement as follows :
(1) Reusable surgical medical device and equipment
(2) Medical device that is exempted from labelling and medical device document, must at least display information in Thai or English as follow:
(a) Medical device name
(b) Name and address of manufacturing site/ importer. In case of Importer, it is required to specify
name, city, and country of manufacturing site, if it is impossible to display name and city of manufacturing site, then name, city, and country of product owner; and country of manufacturing site shall be display instead.
(c) Numbers or alphabets indicating manufacturing LOT or serial number.
(d) M/Y or Y/M of expiration date. Year shall be display with 4 digits number. In case of medical
device with expiration date, it is required to display M/Y and Y/M of expiration date.
Labelling (C) and (D) can be prepare in English abbreviation format.
7. Licensed Medical Device Licensee, Notified Medical Device Licensee or General Medical Device Licensee must prepare labelling in Thai or English accordingly to Clause.5 for custom inspection purpose and shall exempt to display importer’s name and address. However, Licensed Medical Device Licensee, Notified Medical Device Licensee or General Medical Device Licensee must complete labelling and medical device document preparation accordingly to Clause.3 or Clause..4 within 180 days after custom clearance.
8. Secretary-General shall have the right to finalized any decision making regarding any issues arise from the announcement.
9. The Announcement is not applicable in conditions as follow:
(1) Certain medical devices with its own labelling and medical device document announcement requirement.
(2) Manufacturing/importation of medical device exemption under section 27 of the Medical Device Act B.E. 2551 and its amendment (Issue 2) B.E.2562.
(3 Manufacturing/importation of medical device for exportation.
10. This decree shall be implementing from October 31, 2021 onwards.
Translated from official ThaiFDA announcement, by:
References:
Ministry of Public Health Announcement regarding Labelling and Document of Medical device 2020