Thailand FDA

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

Online submission

Notified

Follow CSDT Format

Certificate of Product Registration

Online submission

Licensed

Follow CSDT Format

Certificate of Product Registration

Online 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.

 

TECHNICAL REQUIREMENTS

Qualtech 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.

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Official Website
 
 

 

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