Licensed Medical Device Manufacturer/ Importer and Notified Medical Device Manufacturer / Importer shall prepare documents as listed in the announcement and submit the files application before expiry date of the Licensed Medical Device Manufacturing / Import License and Notified Medical Device Manufacturing / Import License . The list of attached documents is as follow:

(1) Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device  Manufacturing / Import License Renewal guidance

(2) Application form for Licensed Medical Device Manufacturing / Import License Renewal 

(3) Application form for Notified Medical Device Manufacturing / Import License Renewal 

(4) Establishment Declaration Form for testifying as an evidence for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal 

(5) Declaration of conformity template

(6) Letter of authorization for authorized representatives

(7) Letter of establishment suspension. Amount of medical device in stock and place of medical device storage.

(8) Application form for specifying amount of medical device in stock and place of medical device storage upon non-renewal

Guidance for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal 

1. For Licensed Medical Device Manufacturing / Import License renewal , applicant shall submit an application of License renewal along with (2) Application form for Licensed Medical Device Manufacturing / Import License Renewal.

2. For Notified Medical Device Manufacturing / Import License renewal , applicant shall submit an application of License renewal along with (3) Application form for Notified Medical Device Manufacturing / Import License Renewal.

3. Other related documents:

3.1 Licensed Medical Device Manufacturing / Import License and Notified Medical Device Manufacturing / Import License 

3.2 Copy of company certificate with not more than 6 months validity after issued date

3.3 Letter of Authorization to be operator with stamp duty and copy of national identification card of Grantor of authorization and Authorized person.

3.4 (4) Establishment Declaration Form for testifying as an evidence for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal 

3.5 Legalized GMP or Quality system certificate (For Importation)

3.6 Product test report (Only for HIV Screening test kit)

3.7 (5) Declaration of conformity 

3.8 (6) Letter of authorization for authorized representatives  (For Importation) 

4. Fees:

4.1 Submission Fee                                                                    100    THB*

4.2 Licensed Medical Device Manufacturing License              10000 THB

4.3 Licensed Medical Device Import License                           20000 THB

4.4 Notified Medical Device Manufacturing License               5000   THB

4.5 Notified Medical Device Import License                            10000 THB

Remark: *The fee rate may be differed in corresponding to Law amendment

5. Payment method

Payment can be by Cash, Cashier cheque or Draft. 

6. Time frame and place for submission

Submission period starts from October 1, 2020 at One stop service center, Food and Drug Administration, The Ministry of Public Health. In case, submitted  licenses with not more than  1 month to expiry date , Licensee shall be fined with 1000 THB / day accordingly to section 91 Medical Device Act (No.2) 2019.

7. Licensee not interest in license renewal:

7.1 In the case licensee whom wishes to suspense their operation shall apply the letter of establishment suspension specifying  the amount of medical device in stock and notify place of storage and turn it the license within 30 days after the day of establishment suspension. 

7.2 In the case licensee whom wishes to not renew shall apply the application specify the amount of medical device in stock and notify place of storage upon non-renewal within 30 days after December 31st , 2020.


References:

Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal

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