Regulatory Affairs Update Thailand

Thailand: Draft Announcement for the Production or Sale of Medical Devices Exempted under Section 27 (2) (3) and (4)

The Ministry of Public Health (MOPH) of Thailand issued a draft announcement for the production or sale of medical devices exempted under section 27 (2), (3), and (4), with key points as follows:

A. Requirements for production of medical devices for sterilization in hospitals:

1. Sterilization Area:

  1. Three designated areas: Dirty Zone (used equipment), Clean Zone (staff facilities and operating areas), and Sterile Storage Zone.
  2. One-way flow between zones for equipment, staff, and air.
  3. Must be a stable and sturdy location for the sterilization machine and a sealed room for storing sterile medical devices that are free of dust.

2. Sterilization Process:

  • Choose the appropriate method based on device type.
  • Confirm effectiveness through testing.
  • Record information on date of sterilization, medical device type, number of sterilization machine, results, and personnel.

3. Labeling and Storage:

  • Label devices with sterilization date, expiration date, and lifespan.
  • Store sterile devices in a dedicated, closed room.

B. Requirements for production and sale of medical devices produced by medical and public health professional for specific patients or animals:

1. Production sites must be hygienic where dirt may not contaminate the raw materials and production process.

2. Equipment and tools used in production and quality control. Storage of medical devices must be protected from contamination and appropriate in type and quantity.

3. Production control shall comply with the standard.

4. Label must be available for medical devices used by the public. It shall include the name of medical devices, how to use, storage condition, month and year of production, and month and year of expiration unless it has no shelf-life.

5. Record information that shall at least include:

  • Name of the medical device.
  • Date, month, and year of production.
  • Number or letter indicating the production number or machine number.
  • Expiration date of the medical device (if any).
  • Quantity or amount produced.
  • Specify the standard of the medical device.
  • Name of the patient, name of the animal, or owner of the animal.

C.  Requirements for sale of medical devices with a license, or a detailed notification form, or a registration notification by hospital or medical and public health professional for patients or animals:

1. Shall have a proportional sales location and necessary equipment for storing  and maintaining the medical devices.

2. Record of the sale of medical devices shall include at least:

  • Name of the medical device.
  • Quantity or amount sold.
  • Number or letter indicating the production number or machine number.
  • Name of the buyer.

All records made in accordance with this draft announcement may be stored in a form of a hard copy documents or electronic documents in Thai or English. Records shall be kept for a period of more than 1 (one) year of the lifespan of the medical devices and not less than five years from the date of production. Producers or sellers which have been selling medical devices that are exempted under section 27 (2), (3), before the date of this announcement takes effect, shall comply with this announcement within one year from the date this announcement takes effect.

This draft announcement takes effect 180 days after it is published in the Royal Gazette. Further information can be found in the translated draft announcement that can be accessed here.

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