Guideline for Renewal of Licensed and Notified Medical Device Licenses

1. License renewal and Notified Medical Device License which will expire on 31 December 2021, shall proceed License(s) renewal via the SKYNET system. Medical devices renewal is divided into 2 groups as follows:

A). Medical devices whose import permit need to be amended to comply with the risk-based classification:

- Ophthalmic Viscosurgical Device (OVD) (made from living animals)

- surgical gloves - Condoms (contains no medication)

- contact lens

- Test kits related to HIV infection (monitoring)

- Silicone breast implants

B). Medical devices whose import permit DO NOT need to be amended to comply with the risk-based classification:

- Test kits related to HIV infection (Screening test)

- Test kits related to screening for ACE infection (self-check)

- Clamp-on products for use in ophthalmic procedures (Made from synthetics)

- Human blood bags

- Urine methamphetamine drug test kit

- Alcohol level test device

- Insulin syringe other than U-40, U-100

- Teeth whitening products

- Contact lens care products

- Concentrated product for hemodialysis

- Blood bags with anticoagulants

- Condoms (contains medicine as an ingredient)

- Medical devices for physiotherapy (active medical device as in the attached announcement) such as paraffin wax unit / hot pack, hydrocollator pack/ cold pack /controller cold compression unit /steam bath cabinet

- Moist air heat therapy unit or moist steam cabinet

- Therapeutic device with hydrotherapy or immersion hydrobath

- Therapeutic device with galvanic or direct current

- Therapeutic device with Iontophoresis

- Therapeutic device with Interrupted direct current-IDC

- Therapeutic device with sinusoidal current

- Therapeutic device with diadynamic current

- Therapeutic device with faradic current

- Therapeutic device with high voltage current

- Therapeutic device with transcutaneous electrical nerve stimulation-TENS

- Therapeutic device with interferential current-IFC

- Therapeutic device with Russian current

- Therapeutic device with shortwave diathermy-SWD

- Therapeutic device with microwave

- Therapeutic device with static current

- Therapeutic device with magnetotherapy

- Therapeutic device with ultraviolet-UV

- Therapeutic device with infrared-IR

- Therapeutic device with low power laser

- Pressure-applying device

- Electric traction machine

- Ultrasound machine

- Therapeutic device with exercise therapy

- massager such as electric massage chair

The new registration number, consisting of 12 digits Arabic numerals, will be obtain only upon the approval of License(s) renewal application.

2. For the renewal of medical devices, whose import permit needs to be amended to comply with the risk-based classification, a Full CSDT submission dossier must be prepared and submitted via SKYNET system.

3. The renewal of medical devices, whose import permit DO NOT need to be amended to comply with the risk-based classification, shall proceed via SKYNET system.

4. Fees are as follows:

 

5. Duration and place to apply for renewal

The renewals can be made from 1 October 2021 – 31 December 2021 via Skynet. The late Renewal application shall not exceed 30 January 2022. Under section 91 of the Medical Device Act, the late application shall be subject to a daily fine of 1,000 baht per day for the duration of time that the license renewal application has not been submitted. Any renewal submission after 30 January 2022 shall no longer be accepted.

 

 

 

References:
Thai FDA Notification on Licenses Renewal Guideline
Qualtech Newsletter: THAILAND NEW REGULATION FOR MEDICAL DEVICE REGISTRATION 2021