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.
- 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.
- 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.
- 4. Medical devices with serious adverse events history or device deficiencies, which may lead to serious adverse device effect.
- 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
- 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. Applicable for existing Import Permits that expire before February 14,2024,
- with over 1 year validity from February 15, 2021, onwards.
- The submission deadline is dated as February 14, 2024.
- 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.