Thailand: Diagnostics

Division of Primary Regulatory Agency

Medical Device Control Division

Major Functions

The Medical Device Control Division is responsible for overseeing all regulatory aspects of medical devices in Thailand. Medical device regulation is outlined in the Medical Device Act B.E. 2531 (1988) and Medical Device Act B.E. 2551 (2008). The Medical Device Committee is appointed every two years by the Minister of Health. The Committee advises the Minister on regulatory issues for controlling medical devices, and grants registration licenses. As a member of the Association of Southeast Asian Nations (ASEAN), Thailand will adopt the ASEAN Medical Device Directive (AMDD) by December 2014. The AMDD has established a four-tier risk based classification system based on the Global Harmonization Task Force (GHTF) and European Medical Device Directives. Class A devices are the lowest risk and Class D devices are the highest risk.

Key Contacts

Mr. Chapon Ratanapan
Director
Medical Device Control Division
Tel: 66-2590-7254
Fax: 66-2591-8479
mdcd1988@fda.moph.go.th

Relevant Regulatory Harmonization Initiatives

Association of Southeast Asian Nations (ASEAN) Medical Device Directive (AMDD)

Known Collaborations

International Medical Device Regulators Forum (IMDRF), Asian Harmonization Working Party (AHWP), Global Harmonization Task Force via AHWP and APEC

Common Technical Document (CTD) Acceptance

Current medical device application format is unspecified, and the ASEAN Medical Device Directive format will be adopted by December 2015. Details of the ASEAN CTD can be found here.

Clinical Trial Timelines

According to Division of AIDS Clinical Research Support Services, 1 week.

Clinical Trial Import Authorization

Following approval of the study protocol by ethics committees, the investigator can apply for an import license. The application form is "JorPorMor" (JPM) for medical devices. The application form should be completed in Thai, with supporting documents in either Thai or English. One A4 hard copies are required for the application. Applications should be submitted here:

Address for submission of all applications:
One Stop Service Center
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road,
Nonthaburi 11000
Thailand

Tel: Int. +66 2 5907439 (medicinal products)
Int. +66 2 5907420 (medical devices)

Address of International Affairs and Investigational New Drug Section:

International Affairs and Investigational New Drug Section
Drug Control Division
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanond Road,
Nonthaburi 11000
Thailand

Tel: Int. +66 2 5907167 or Int. +66 2 5907061
Fax: Int. +66 2 590 7061

The entire process takes an estimated 1 week for medical devices.

Clinical Trial Costs

Fees depend on the research institution and vary by ethics committee. Fees range from THB 5000 - THB 53,500.

In-Country Manufacturing Requirements

Manufacturing practices are governed by the Medical Device Control Division. The Medical Device Control Division states that Good Manufacturing Practices (GMP) guidelines are in the works, with expected annual assessments encompassing product sampling and testing. Good Manufacturing Practices certificates will be awarded to manufacturers who pass the assessment. More information is available here.

Liability Policy

There are no national requirements for clinical trial insurance. Ethics committees require an informed consent statement that guarantees the availability of treatment for a study-related injury, and whether or not compensation will be offered.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

14 clinical trials approved from June 2012 to June 2014.

Product Registration Data Requirements

The Medical Device Act outlines three categories of medical devices.

Class 1: Medical devices that require a license prior to being able to manufacture or import the device.

-Condoms.
-Rubber gloves for physical examinations or surgical operations.
-Hypodermic and insulin syringes.
-HIV infection test kits for diagnostic purposes.
-Contact lenses.

Class 2: Medical devices that require the manufacturer or importer to provide specifications of the product prior to being able to manufacture or import the device. 

-HIV infection tester kits for non-diagnostic purposes.
-Equipment or products used in physical therapy.
-Alcohol tester kits.
-Implanted silicon breast prostheses.

Class 3: ("General Medical Devices")-Medical devices that do not fall under Classs 1 and 2 (devices considered of the lowest risk).

For Class 1 devices, licenses must be obtained from the Thailand Food and Drug Administration (FDA) prior to manufacturing or importation. The Application requires:

1. Medical device establishment license application form.
2. Photograph of person authorized to do business (3 copies).
3. Copy of commercial registration certificate or incorporation certificate.
4. Power of attorney for the person who is authorized to do business.
5. Power of attorney for person who is authorized to submit the documents.
6. Copy of identify card of authorized person.
7. Copy of household registration of authorized person. If the authorized person is a foreigner, a copy of the designee's passport, household registration or evidence of permission to enter Thailand for temporary stay are required.
8. Medical certificate of authorized person.
9. Map indicating location of manufacturer and storage facility (2 copies).
10. Plan for the manufacturing and storage facility (2 copies).
11. Photograph of the manufacturer and storage facility (2 copies).

All application requirements are listed here.

More information is available here.

Product Registration Estimated Timeline

According to Pacific Bridge Medical, for Class 3 devices, the Thai FDA will issue an import license within 3-5 months if documents are properly submitted.

Product Registration Costs

The application fee is THB 100. A full list of registration fees is available here.

Post Registration Labeling Requirements

Section 25 of the Drug Act B.E. 2510 (1967) contain labelling requirements. The Act can be found here.

Post Registration Pharmacovigilance Requirements

Investigators are expected to submit serious, suspected, and unexpected safety reports to ethics committees when adverse events occur. Timelines for reporting varies based on ethics committee. For serious unexpected adverse drug reactions only, investigators must submit serious adverse events to the Thailand Food and Drug Administration (FDA) Drug Control Division. Submission of safety reports from adverse events in other countries can be submitted annually in an Annual Safety Reports/Line Listing, but this is not mandatory. There is no preferred adverse events reporting format. Reporting should be hand delivery, no electronic reporting is accepted.

Once registration is obtained, the license older needs to create and submit a protocol of Safety Monitoring Programme to the FDA. Products must follow this for at least two years.

Marketed products samples are tested regularly to monitor for compliance. Deficiencies can result in product recall. 

Last Updated

September 26, 2014.