Request FDA License for Medical Devices
To request FDA license for medical devices, we offer the services for two categories.
(Currently we are unable to serve for FDA product registration and and its import lidenses.)
Manufacture and Import license of medical devices
Sale license of medical devices
For Example: Request import license of general medical device
Provision Cost
Government Fee 34,300
Note: The cost does not cover for the evaluation of academical documents of medical device and importing more than 10 lists.
Procedure and Timeline
I. Registration the place of importation
Step 1: Prepare the required documents and fill the application form
- Application form (Sor Phor. 1, Sor Nor. 1)
- 5 inch Photo of applicant (3 sets)
- Copy of business registration or commercial registration (1 set)
- Copy ID card/ Passport and work permit of applicant (1 set)
- Copy of registered address (1 set)
- Health Certificate of applicant which describes mentally sick or declared incompetent or quasi-incompetent must not be afflicted with leprosy, tuberculosis in the dangerous stage, elephantiasis in the stage where the symptoms appear to be socially objectionable, severe drug addiction and chronic alcoholism.
- Power of Attorney ( 1 set)
- Copy of ID card and registered address of delegated person ( 1 set)
- Map of location for import and storage ( 2 set)
- Internal map of import and storage place (1 set)
- Photo of location : import and storage place (2 set)
- Authenticate the scale of billboard for import and storage place (2 set)
In case of the leasing place, additional required documents are
- Consent letter of using the place for keeping medical devices (storage place)
- Proof letter of ownership over storage place (In case of a copy, please certify)
Step 2: Submit to Thai FDA
The officer will check the accurate of evidence and supporting documents by taking 11working days and appoint the date to check the place and will approve the license after the place follows their standard by taking 5 working days.
Step 3: Receive the approval license
Remark: If there are no additional documents required and no accurate of evidence document occurred or the location meet their standard, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.
II. Registration the import license of General Medical Device
Step 1: Prepare the required documents and fill the application form
Required Documents
- Application form (Nor Por.1)
- At least 2 reference letters certified by a manufacturer or importer in English version (original and copy)
- Executive Summary of medical device in Thai version (1 set of Original and Copy)
- Essentials principles of Safety and Performance of Medical Device and Method used to demonstrate conformity in Thai or English version (1 set of Original and Copy)
- Device description in Thai version with each topic as below (1 set of Original and Copy)
- Device description and features
- Intended use
- Indications
- Instructions for use
- Storage condition
- Shelf life (if any)
- Contraindications
- Warning
- Precautions
- Potential adverse effects
- Alternative therapy
- Material
- Other relevant specification
- Other descriptive information
- Summary of Design Verification and Validation Documents in Thai or English version (1 set of Original and Copy)
- Device Labeling in Thai version (1 set of Original and Copy)
- Risk analysis in Thai or English version (1 set of Original and Copy)
- Manufacturer Information in Thai or English version (1 set of Original and Copy)
- Certificate of Free Sale ( 1 set of Original and Copy)
- GMP or quality system certificate (*depend on case) (1 set of Original and Copy)
- Declaration of conformity (1 set of Original)
- Letter of authorization for authorized representative (1 set of Original and Copy)
- Any other information related to medical device in Thai or English version (1 set of Original and Copy)
- Letter of authorization to conduct business (regarding to registered place of importation) with copy of ID of both parties (1 set of Original)
- Copy of registered place of importation (1 set)
- Copy of company affidavit not over 6 months (1 set)
Step 2: Submit to Thai FDA
The officer will check the accurate of evidence and supporting documents by taking 88.5 working days and will approve the license of product by taking 3 working days.
Step 3: Receive the approval license of product
Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.
III. Registration the Certificate of General Medical Device Importation
Step 1: Prepare the required documents and fill the application form
Required Documents
- Original of Certificate of Free Sale and/or Certificate of manufacturing quality system (2 set of Copy)
- Copy of commercial registration or company affidavit with its objectives which is not more than 6 months (1 set)
- Catalog or Label or User Manual which include product specification or detail of product including usage and other related documents, Packing insert or Price list
- Copy of registered place of import (1 set)
- A letter of process controller ant the notify ID number of product
- Power of attorney (1 set)
Step 2: Submit to Thai FDA
The officer will check the accurate of evidence and supporting documents by taking 6 working days and will approve the license and issue the license by taking 1 working day.
Remark:
- The lists of import are between 1 to 100 lists, it will take 4 days for issuing license
- The lists of import are over 100 lists, it will take 5 days for issuing license
Step 3: Receive the certificate of medical device importation
Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.
IV. Request license per invoice (LPI)
This procedure will depend on the product, some may require but some may not.
Remark: Must have import or export license or shipping provider in order to import to Kingdom of Thailand.
For more information, please feel free to contact us:
Phone Nos.: +66 2933 9000
(For call inside Thailand use 0 instead of +66)
Fax: +66 2933 6120
Email: mgr@panwa.co.th
Please CC: to our alternate email: panwagroup@gmail.com