It is mandatory for Ophthalmic Viscosurgical Devices; Blood Bag; Implanted Silicone Breast Prosthesis; Breast enhancement; HIV Test Kits; Teeth Whitening; Injectable Hyaluronic Acid to obtain Seller’s License upon their post-market activity.
Seller’s Licensee shall prepare documents as listed in the announcement and file for submission before the License expiry date. The list of attached documents are as follow:
1. Application form for Seller’s License
2. Letter of establishment suspension. Amount of medical device in stock and place of the medical device storage.
3. Application form for a specified amount of medical device in stock and place of medical device storage upon non-renewal
4. Application form for a specified amount of medical device in stock and place of medical device storage upon expiry sales period
Seller’s License Renewal Fees:
1. Submission Fee 100 THB
2. Seller’s License Renewal Fee 1000 THB (Valid until December 31st, 2021)
3. Seller’s License Renewal Evaluation Fee 12000 THB
Remark: The fee rate may be differed in corresponding to the Law amendment.
In case when licensees submitted renewal submission with not more than 1 month from the expiry date, the Licensee shall be fined 1000 THB / day accordingly to section 91 Medical Device Act (No.2) 2019.
Licensee does not interest in license renewal:
1. In the case of licensee who wishes to suspense their operation shall apply the letter of establishment suspension specifying the amount of medical device in stock and return Seller’s License within 30 days after the day of establishment suspension.
2. In the case of licensee who wishes to not renew shall apply the application in specifying the amount of medical device in stock and place of medical device storage upon non-renewal within 30 days after December 31st, 2020.
3. Licensee who proceeded establishment suspension, whose License has expired or had been rejected by the licensor, may sell the remaining medical devices to other licensees following the regulation under Section 38 Medical Device Act.
3.1 The remaining medical devices must merely be sold to other licensees or other parties that were approved by the licensor within 60 days after the day of establishment suspension, License expiry date, or rejection date. The licensee is prohibited to sell any remaining medical devices after the provided timeframe. If fail to comply, Licensee shall be liable to imprisonment for a term not exceeding 2 years or a fine not exceeding 200,000 THB accordingly to section 91 Medical Device Act
3.2 If there is a remaining medical device after 60 days of establishment suspension, Licensee expiry date, or rejection date, Licensee shall apply the application specifying the amount of medical device in stock and place of medical device storage upon expiry sales period within 15 days after expiry sales date. If fail to comply, Licensee shall be liable to a fine not exceeding 10000 BTH according to section 97 Medical Device Act.
Food and Drug Administration Announce Documents Preparation for Seller’s License Renewal in 2020