There are a total of 5 categories of Medical Devices that shall ONLY proceed with the Full CSDT Submission. Applicable submission route and medical device under Partial 2 submission prior its suspension of the grace period dated on 13 February 2024.

Full CSDT Submission:

1. Medical devices with new technology (AI: Artificial Intelligence)

2. Medical devices, which are amended from hospitals and professional use to home use.

For example,

    • laser hair stimulation,
    • LED red light wrinkle reduction or other light colors (except blue light to treat acne)

3. Medical devices that require a “specialist evaluation” to prove its efficacy and safety.

For example,

    • products that do not contain hyaluronic acid used to correct skin defects,
    • silk products used for lifting such as polydioxanone silk, gold silk,
    • products used for intracellular storage, such as platelet rich plasma (PRP) or stem cells and injecting such cells back into the human body.

  1. 4. Medical devices with serious adverse events history or device deficiencies, which may lead to serious adverse device effect.

  1. 5. Medical devices with specific guidance announced by the Ministry of Public Health
    • Injectable Hyaluronic Acid for Skin Correction
    • Implanted Silicone Breast Prosthesis
    • Human Blood Bags
    • Condoms
    • Ophthalmic Viscosurgical Devices
    • Surgical gloves
    • Contact Lenses
    • Concentrates for Hemodialysis
    • Teeth Whitening
    • Contact Lens Care Products
    • Products Containing Alcohol for Medical Devices
    • Physical Therapy Equipment
    • Insulin syringe (other than U-40, U-100)
    • HIV Test Kits
    • HIV Self-Tests
    • Methamphetamine Urine Drug Test Kits

Partial 2 Submission:

  1. 1. Applicable for existing Import Permits that expire before February 14,2024,
  2. with over 1 year validity from February 15, 2021, onwards.
  3. The submission deadline is dated as February 14, 2024.

  1. 2. Medical devices other than mentioned in 1.), and which shall be submitted within the grace period. The submission deadline is likewise dated as February 14, 2024.



Thai FDA: Medical Device Categories for Full CSDT Submission and Partial 2 Registration Route