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Request FDA for Medical Devices

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Description

To request FDA license for medical devices, we offer the services for two categories.
I. Manufacture and Import license of medical devices
II. Sale license of medical devices

I. Manufacture and import license of the medical devices

Provision Cost
1.Government fee for manufacture license of the medical devices 10,100
2.Government fee for import license of the medical devices 20,100
3.Evaluation of academic papers for medical device type 1 25,000
4.Evaluation of academic papers for medical device type 2 38,000
5.Evaluation of academic papers for medical device type 3 63,000
6.Evaluation of academic papers for medical device type 4 88,000

Procedure and Timeline
Step1. We will discuss with you and provide the application form that need to be filled.
Step2. We will collect the required documents from your side.
Step3. We will submit to Thai FDA.
It will take 90 working days or more than that to get the approval licenses.

Note: Type of Medical Devices
1) Low risk
2) Moderate risk (Low)
3) Moderate risk(High)
4) High Risk

Required Documents
1. Executive Summary (Copy and Original)
2. Essential Principles of Safety and Performance of Medical Device and Method used to demonstrate Conformity (Copy and Original)
3. Device Description in Thai (Copy and Original)
4. Summary of Design Verification and Validation Documents (Copy and Original)
5. Device Labeling (Copy and Original)
6. Risk analysis (Copy and Original)
7. Manufacturer Information (Copy and Original)
8. Certificate of free sale (Copy and Original)
9. GMP or quality system certificate (Copy and Original)
10. Declaration of conformity (Original)
11. Letter of authorization for authorized representatives (Copy and Original)
12. Letter of authorization for authorized business operator(Copy of ID or passport of both parties)
13. Copy of company affidavit (no more than 6 months)
14. Other information related to medical devices (Copy and Original)
15. Copy of factory or import license for medical device
16. Supporting documents ( 2 set)

II. Sale license of the medical devices

Provision Cost
Government fee 13,100

Procedure and Timeline
Step1. We will discuss with you and provide the application form that need to be filled.
Step2. We will collect the required documents from your side.
Step3. We will submit to Thai FDA.
It will take 15 working days to the get the approval of sale license.
Note; It may be varied regarding to the documents are incomplete or officer inspection.

Required Documents
• Medical device approval form (Original)
• Control procedures for issuing medical device sale license (Original)
• 1 inch photo (3)
• Copy of Company affidavit (Not more than 6 months)
• Copy of Company affidavit with its objectives (Not more than 6 months)
• Letter of authorization to appoint authorized business operator (Original)
• Copy of ID card or Passport and house registration
• Health certificate of the business operator (Original)
• Location map for storage and selling (Original 2 set)
• Location map inside of storage and selling (Original 2 set)
• Color photo of storage and selling (Original 2 set)
• Billboard certificate for both storage and selling (Original)
• Copy of house registration for storage and selling
• Consensus letter for using a place as medical device storage (Original) (In case of you are not the owner of place)
• Certified proof letter as an owner of storage place and stamp seal (Original)

For more information, please feel free to contact us:
Phone Nos.: +66 2933 6121, +66 2933 6122, +66 2933 5601
(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

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Listing ID: 4425b6926e6bc7c7

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