By virtue of (3) of the definition of "Medical device" under Section 4, Section 6 (1) (b) And Section 44, paragraph two of the Medical Device Act 2008, as amended by Medical Device Act (Issue 2) 2019, Section 5 Paragraph 1, Section 6 (4) (5) (10) And (13) and section 45 paragraph two of the Medical Device Act 2008 with recommendations of the Medical Device Committee  have released an announcement as follows:

1. In this announcement "Products containing alcohol for humans and animal sterilization" means product which contains ethyl alcohol/ethanol or isopropyl alcohol/isopropanol, combined from or more that 70% volume and water only in a form of cotton ball, swab, swab stick, pad, applicator, unit dose/single dose/individual packaging that have direct contact on skin to for wound sterilization.

2. All products containing alcohol for humans and animal sterilization, manufacturer and importer must prepare the registration of medical device to be notified in order to import the product.

3. All products containing alcohol for humans and animal sterilization must have standard in accordance with the requirement of Drugs by the Minister, along with Microbiological Attributes test result and Stability test results that follows ASEAN guideline on Stability Study of Drug Product.

4. Must be produced by manufacturers that have been certified for production quality for such products in accordance with national standards or international standards such as standards, criteria and good methods in the production of medicines Pharmaceutical Inspection Co-operation Scheme (PIC/S) Criteria and methods for good production of medical devices (GMP) International organization standards for (ISO 13485: 2003 or ISO 13485: 2016) or newer.

5. Products containing alcohol for humans and animal sterilization labelling must be as follow:

(1) Container of products containing alcohol for humans and animal sterilization must provide labelling in Thai or English that are clearly readable on product packages or its container. With at least these following items:

(a) Trade name of the product;

(b) Name and concentration of all components;   

(c) Name and address of the manufacture site. For importer, provide address of the manufacturer;

(d) Year and Month or Month and Year for manufacture date. Manufacture year must be 4 digits;

(e)  Year and Month or Month and Year for expiry date or use before. Expiry date must be 4 digits;

(f) Number or letter indicating LOT number or manufacture number;

(g) Number of the registration license of medical device to be notified.

             (h) Instruction for use and storage methods and precautions;

(i) Message of "For disinfecting the skin or wiping around the wound";

(j) Message of "Single use only";

(k) Message of "For external use only";

(l) Message of "Flammable substance. Keep away from fire or flame";

(m) Message of "Do not use if the package is damaged or torn" shown in red letters;

(n) Message of: Do not sell directly to end user” shown in red letters in case of product that is in primary container.

Labelling (d) (e) (g) (i) (j) (k) (l) and (m) must be in Thai.

Instruction for use and storage methods and precautions (h) can be include in device documentation if cannot include in labelling.

(2) Primary container that is sold directly to end user must have labelling in Thai or English that are clearly readable on product packages or its container. With at least these following items:

(a) Trade name of the product;

(b) Name and concentration of all components;

(c) Name and address of the manufacture site. For importer, provide address of the manufacturer;

(d) Year and Month or Month and Year for manufacture date. Manufacture year must be 4 digits;

(e)  Year and Month or Month and Year for expiry date or use before. Expiry date must be 4 digits;

(f) Number or letter indicating LOT number or manufacture number;

(g) Number of the registration license of medical device to be notified.

(h) Message of "For disinfecting the skin or wiping around the wound";

(i) Message of "Single use only";

(j) Message of "For external use only";

(k) Message of "Flammable substance. Keep away from fire or flame";

(l) Message of "Do not use if the package is damaged or torn" shown in red letters; 

 2) Primary container that is not sold directly to end user must have labelling in Thai or English that are clearly readable on product packages or its container. With at least these following items:

(a) Trade name of the product;

(b) Name and concentration of all components;

Labelling according to 5 (1) and (22), if English abbreviations are being employed the meaning of the abbreviations shall be included in device document.

6. In order to sell products containing alcohol for humans and animals sterilization in Thailand, products must labelling in Thai or other languages that are clearly readable on product packages or its container. With at least these following items:

(1) Trade name of the product;

(2) Name and concentration of all components;

(3) Name and address of the manufacture site. For importer, provide address of the manufacturer;

(4) Instruction for use and storage methods and precautions;

(5) Message of "For disinfecting the skin or wiping around the wound";

(6) Message of "Single use only";

(7) Message of "For external use only", and

(8) Message of "Flammable substance. Keep away from fire or flame".

7.  In the case of importing products containing alcohol for humans and animals sterilization, the importers must prepared the labelling on the packages according to clause 5,6 before selling, within thirty days from the date that medical device has checked for release.

8. All products containing alcohol for humans and animals sterilization that manufactured for export only must meet the standard and requirements for labelling according to the agreement between the 2 parties.

9. Registration of the drug certificate holder,  for products containing alcohol for humans and animals sterilization before the effective date of this notification and wishes to continue operating, must apply for establishment import license along with preparing the registration of medical device to be notified within the period of 30 days from the effective date of this notification.

10. This announcement shall come into force after 180 days from the date following the date of its publication in Government Gazette onwards.

Translated from official ThaiFDA announcement, by:

Reference:
Ministry of Public Health Announcement regarding Products Containing Alcohol for Humans, Animals Sterilization and Medical Device 2019

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