The Thai Food and Drug Administration (Thai FDA) has released new guidelines for medical device sellers operating in Thailand. Effective immediately, these guidelines outline the necessary steps for compliance with regulatory requirements, including obtaining a sale license where applicable.
Key Steps for Medical Device Sellers
Step 1: Determine Whether a Sale License is Required
Medical device sellers must first determine if their products require a sale license. A full list of medical devices requiring a sale license can be found in the Medical Devices Requiring a Sale License section.
Note: Manufacturers and importers of medical devices requiring a sale license are automatically considered licensed sellers and do not need to apply separately.
Note: Manufacturers and importers of medical devices requiring a sale license are automatically considered licensed sellers and do not need to apply separately.
List of Medical Devices Requiring a Sale License (Total: 19 Products):
- HIV-related test kits for in vitro diagnostic use (excluding HIV self-testing kits)
- Human blood collection bags
- Ophthalmic viscous surgical devices
- Teeth whitening products
- Silicone breast implants
- Hyaluronic acid injections for dermal skin
- Dental implants
- Orthodontic brackets, braces, elastics, wires, and bands
- Clear dental aligners
- Dental etching materials, filling materials, bonding agents, or cementing agents (excluding denture adhesive)
- Impression materials for dental use
- Artificial teeth
- Fluoride varnish
- Positive Airway Pressure (PAP) devices
- Option 1: If the product is not listed above, it may be sold in the market without a sale license.
- Option 2: If the product is listed above, proceed to Step 2.
Step 2: Submit a Sale License Application
Medical device sellers whose products require a sale license must apply through the appropriate channels:
- For sale locations in Bangkok:
- Applications must be submitted online through the Thai FDA system.
- Resources available:
- Sale license entitlement registration
- Submission process details
- e-Submission manual for Bangkok-based sale license applications
- Relevant application forms
- For sale locations outside Bangkok (provincial areas):
- Applications must be submitted to the Provincial Public Health Office (PPHO).
- Resources available:
- Manual for medical device sale license applications in provincial areas
- Relevant application forms
- Ministry of Public Health Announcement on Medical Devices That Must Be Sold Only to Healthcare Facilities or Healthcare Professionals, B.E. 2563 (2020).
Step 3: Compliance After Receiving the Sale License
Licensed sellers must adhere to ongoing regulatory responsibilities, including:
- Annual sale report submission
- Sale license renewal process
- Notification of business discontinuation or non-renewal of sale license
- Ministry of Public Health Announcement on the Quality System for Importing or Selling Medical Devices, B.E. 2566 (2023).
Step 4: Advertising Medical Devices
Advertising a medical device involves any form of promotional activity aimed at public awareness. Prior approval is required before advertising.
There are two types of advertising applications:
There are two types of advertising applications:
- Advertising to the public
- Advertising directly to healthcare professionals
Further Information
For official guidance, visit:
- Thai FDA Official Website (in Thai): กองควบคุมเครื่องมือแพทย์ (moph.go.th)
- Thai FDA Facebook Page: https://www.facebook.com/fdathaidevice