IVD Medical Device Registration in Thailand
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements by the Thai government.
Why Register Your IVD Medical Device in Thailand?
Expanding Market Opportunities
Expanding Market Opportunities
Thailand’s IVD market is one of the largest in Southeast Asia, showing strong growth due to the increasing demand for advanced diagnostic solutions. By registering your IVD device in Thailand, you gain access to a market that is continuously expanding, driven by the need for improved healthcare services and innovative diagnostic technologies.
Regulatory Compliance and Market Credibility
Regulatory Compliance and Market Credibility
Registering your IVD device with the Thai Food and Drug Administration (Thai FDA) ensures compliance with local regulations, enhancing your product’s credibility and acceptance in the market. Compliance with stringent regulatory standards demonstrates your commitment to safety, efficacy, and quality, which can significantly boost your reputation among healthcare providers.
Strategic Location in Southeast Asia
Strategic Location in Southeast Asia
Thailand’s strategic location serves as a gateway to other Southeast Asian markets. Successful registration and commercialization of IVD devices in Thailand can facilitate expansion into neighboring countries, leveraging the established regulatory and distribution frameworks.
Our IVD Medical Device Registration Services
Regulatory Strategy
Customised regulatory strategy tailored to to streamline the registration process for your IVD device in Thailand.
Dossier Preparation
Compiling and reviewing all necessary documentation based on Thai FDA requirements.
Submission Management
Managing the entire submission process, including communication with the Thai FDA.
Post-Market Compliance
Assist in adverse event reporting, change notifications and more.
Registration Process Overview
Step 1: Classification
As of February 2021, Thailand has updated its classification categories for medical devices, including both IVD and non-IVD products, from three to four risk categories:
- Previous Classification: General, Notified, Licensed
- New Classification:
- Class 1 (Listing): March 17, 2021
- Class 2 to 4 (Notified and Licensed): February 15, 2021
The new regulations allow all Classes 1, 2, 3, and 4 to benefit from grouping under one registration submission:
- Single
- Family
- System
- Set
- IVD Test Kit
- IVD Cluster
Step 2: Submission
Documentation required for registration includes:
- Device description
- Pre-clinical studies
- Device labeling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s ISO 13485 compliance
Step 3: Evaluation
Once submitted, the Thai FDA will evaluate the documentation. If the documentation meets the requirements, the Thai FDA will issue the appropriate certificate (Listing, Notification, or Licence).
The Thai FDA might require additional documents and reevaluate the submission.
Step 4: Approval
Depending on the product classification and the validity of existing certificates, the approval process varies:
- Class 1 Listing Medical Devices:
- Products with less than 1 year of validity remaining as of February 15, 2021, require partial submission for listing.
- Products with more than 1 year of validity remaining or new products require full submission before importation.
- Class 1 Listing Certificate is valid for 5 years.
- Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices :
- Certificates are valid for 5 years.
Step 1: Classification
As of February 2021, Thailand has updated its classification categories for medical devices, including both IVD and non-IVD products, from three to four risk categories:
- Previous Classification: General, Notified, Licensed
- New Classification:
- Class 1 (Listing): March 17, 2021
- Class 2 to 4 (Notified and Licensed): February 15, 2021
The new regulations allow all Classes 1, 2, 3, and 4 to benefit from grouping under one registration submission:
- Single
- Family
- System
- Set
- IVD Test Kit
- IVD Cluster
Step 2: Submission
Documentation required for registration includes:
- Device description
- Pre-clinical studies
- Device labeling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s ISO 13485 compliance
Step 3: Evaluation
Once submitted, the Thai FDA will evaluate the documentation. If the documentation meets the requirements, the Thai FDA will issue the appropriate certificate (Listing, Notification, or Licence).
The Thai FDA might require additional documents and reevaluate the submission.
Step 4: Approval
Depending on the product classification and the validity of existing certificates, the approval process varies:
- Class 1 Listing Medical Devices:
- Products with less than 1 year of validity remaining as of February 15, 2021, require partial submission for listing.
- Products with more than 1 year of validity remaining or new products require full submission before importation.
- Class 1 Listing Certificate is valid for 5 years.
- Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices :
- Certificates are valid for 5 years.
Typical Fees and Timeline
| Item | Class 1 Listing | Class 2 Notification | Class 3 Notification | Class 4 License |
|---|---|---|---|---|
| Application fee | THB 500 (~US$17) Effective on: 17th March 2021 | THB 1,000 (~US$35) Effective on: 17th March 2021 | THB 1,000 (~US$35) | |
| Evaluation fee | THB 600 (~US$20) | THB 38,000 (~US$1,275) | THB 53,000 (~US$1,775) | |
| License fee | THB 2,000 (~US$67) | THB 10,000 (~US$335) | THB 20,000 (~US$670) | |
| Turnaround time | 1 - 80 days | 250 days | 300 days | |
