Thailand Medical Device Registration
The Thai medical device market in the past years has been greatly supported by the advantages of its service quality and standard. The policy for a Medical Hub, which the Thai government has announced since 2003, has resulted in a gradually growing Medical Tourism industry. Qualtech is your ideal partner to for your foray into the Thailand medical device market for an easy and smooth registration process.
Qualtech in Thailand
Establishment Importer License
We are Thailand Government approved entity to process regulatory and distribution work of medical device. We successfully assisted foreign manufacturers to access local market.
Local Market Access
Qualtech Thailand team offers you ONE-STOP market access service, covering Regulatory research, Product diagnostic, Registration, Importation, Distributor connection.
QT Services
Medical Device Registration
We can provide you excellent step-by-step professional service in compiling a submission dossier, known as the CDST and submit on Thai Food and Drug Administration (ThaiFDA) Medical Device Control Division, and follow up and liaise with the authorities to get your medical devices registered in Thailand.
Authorized Representation
Only companies which hold Establishment Importer License can be the local agent in Thailand. Qualtech’s service includes holding the license or CPR on behalf of foreign manufacturers seeking and aiming to market medical devices in Thailand. Furthermore, we are your bridge to Thai FDA and Thai Custom.
Medical Device Importation
Qualtech can supervise the successful import and custom clearance of your medical devices and provide full marketing support. We establish an experienced team to process custom clearance and ensure your products can be shipped to the distributor in safety.
Overview of Thai FDA Regulation
Medical devices in Thailand are regulated by a specialized division in the Thai FDA. The Medical Devices Control Division ensures that medical devices are wisely regulated and meet safety, quality, and efficacy standards. Submission dossiers are required to be prepared according to the harmonised CSDT guideline.
Only local representative holding an Establishment Importer License is allowed to make medical device registration with Thai FDA. There is no exclusive agent concept and no limitation is imposed to the quantities of devices for 1 Establishment Importer License holder as long as the “Specialty” scope on the license covered the UMDNS code of imported product.
Classification
General
Follow ThaiFDA Format
Product Importation License
e-copy + Hard copy submission
Notified
Follow CSDT Format
Certificate of Product Registration
Hard copy submission
Licensed
Follow CSDT Format
Certificate of Product Registration
Hard copy submission
NOTE: ThaiFDA currently follows Policy-based, not Risk-based, for medical device classification. Therefore applicants are not required to categorize the risk classification. Risk classification is applicable only for evaluation process.
 |
General | Notified | Licensed |
|---|---|---|---|
| Executive Summary | Yes | Yes | |
| Essential Principles of Safety and Performance | Yes | Yes | |
| Device Description | Yes | Yes | |
| Summary of Design Verification and Validation | Yes | Yes | |
| Device labelling | Yes | Yes | |
| Risk analysis | Yes | Yes | |
| Manufacturer Information | Yes | Yes | |
| User Manual | Yes | Yes | Yes |
| Clinical evidence | Yes | Yes |
Note: Kindly see the Notified MD, Licensed MD for more details.
Workflow
FDA Target Reviewing Turnaround Time
After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the FDA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.
General medical device
One item - 1 working day
100 items - 4 working days
≥ 100 items - 5 working days
Medical device to be Notified
40 working days
60 working days ( in case of specialist/committee approval)
250 working days ( in case of new medical device)
Medical device to be Licensed
40 working days
60 working days ( in case of specialist/committee approval)
250 working days ( in case of new medical device)
Note: If there is no registered device similar to your device, then you have to undergo “Product Diagnostic” at initial stage to obtain the “UMDN code” and “Specialty scope of Establishment Import License”. Thai FDA would classify your device as “General”, “Notified” or “Licensed” medical device. Currently, Thai FDA announces “PRP product” and “Absorbable suture” should apply for Product diagnostic in mandatory.
Validity
-
Types of Certificates: Product Importation License, Certificate of Product Registration
-
Product Importation License(General MD): According to CFS’s expiration or 5 years max.
-
Certificate of Product Registration(MD to be Notified & Licensed): 5 years
Tips
The Notice of Importer
Importer must make sure that before every importation of medical device, establishment import license part of “Specialty” has covered the product’s UMDNS code. If the specialty category of the Establishment Import License did not cover the UMDNS code of the medical device expected to be import.
Importer required to have two files before hand in order to proceed custom clearance:
-
License Per Invoice (LPI)
-
Establishment import license
For more information, please refer to the Thai FDA official website at Thai FDA’s official website or you may contact us for a free consultation.
Official Website
Recommendation
[ANALYSIS] The Overview of medical device market and regulation in Thailand
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