Medical Device

Medical Device Registration in Thailand

All medical devices, whether manufactured domestically in Thailand or imported, must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health. Medical device registrations in Thailand must be submitted via the online medical device registration system called the “E-submission system”.

Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA).

The regulatory process is based on the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2). New regulations recently went into effect on February 15, 2021, bringing closer alignment with the ASEAN Medical Device Directive (AMDD).

An Establishment License issued by the Thai FDA of the local registrant and license holder is also required. The registration is divided into 2 parts: the request for a place to import medical devices and the request for a place to store medical devices in Thailand.

Product Categorization

Medical Products in Thailand are classified into 4 categories (1 through 4) based on risk and closely follow ASEAN MDD guidance. Guidance for classifying products according to Annex 2 of the ASEAN MDD but additional guidance and Thai specific rules

Guidance Document Name

Purpose

Ministerial Regulations, Medical Device Products required Listing Approval

Outlines classification criteria for a Class 1, Listing category.

Ministerial Regulations, Medical Device Products required Notification Approval

Outlines classification criteria for a Class 2 or 3, Notification category.

Ministerial Regulations, Medical Device Products required License Approval

Outlines classification criteria for a Class 4, Licensing category.

Device Conformity Assessment

Medical devices will be required to undergo one of three registration routes to acquire an Import License depending on their classification. Class 1 products will require a Listing, Class 2 and 3 will require a Notification and Class 4 (highest risk) will require a License. Conformity Assessments under the new regulations will require applications for Class 2-4 products be submitted in the Common Submission Dossier Template (CSDT) format while Class 1 Listed products require less documentation. Some products (high risk IVDs, gloves, etc.) may require in-country testing and will be determined on a case-by-case basis.

Fees and Timeliness for Registration Medical Device in Thailand

As the regulations only recently went into effect, the timelines are based on formal guidance documents and not LHM’s experience.

This information will be updated as more registrations are issued under the new guidance. Government Fees are also still under review and may change. We will update once the government has more info on the Specialist Review process for medical devices

Other Specialist Review Fees (If Required)

Advertising

20,000THB (~US$ 600)

Justification

38,000 THB (~US$ 1,200)

Our registration services include:

  • Standard product registration
  • Special access product registration
  • Renewal of product registration

Our authorized representative services include:

  • Liaison with the local authorised government agency on all regulatory issues relating to your medical device
  • Regulatory monitoring to alert you to any changes or new regulation applicable to your product
  • License holding
  • Adverse event reporting and management
  • Product alert and recall tracking
  • Complaint handling

We also offer additional support services such as:

  • Importation
  • Storage and warehousing
  • Relabelling