Thailand Medical Device Registration Overview

Thailand Medical Device Registration is controlled by the Medical Device Control Division (MDCO) in the Thai Food and drug administration (FDA). There have been changes to the requirements and procedures for approvals from the regulatory body. Thailand presents an enormous market for medical devices; however, obtaining local FDA approval may not be easy.

Thailand Medical device registration: Target Market Control Pathways and Risk Classification

The Target Market (Thailand) classifies the medical devices in four categories based on risk as per ASEAN Medical Device Directive (AMDD). These regulations for the medical devices determine the particular market entry control pathway and premarket requirements:

• Class I (Low Risk): Regulation under Listed Devices, Section 6(1)(c). The manufacturer or importer is required to get a Listing Receipt prior to the commencement of the business operations. Listing Receipts will be valid until the 5th year from the date of issue.

• Class II (LowModerate Risk) & Class III (ModerateHigh Risk): Regulation under Notified Devices (Specifications Declared Devices under Section 6(1)(b)). The importer or manufacturer is required to get a Specifications Declaration Receipt.

• Class IV (High Risk): Regulation under Licensed Devices, Section 6(1)(a). Full Medical Device License is required before commercialization of the device.

Thai Food and drug administration Registration Process for US (FDA) and European (CE Mark) Approved Devices

For medical devices that have the CE mark from the European Union Notified Bodies (EU NB) and US Food and Drug Administration (US FDA) for US companies, there is a quick market access called the Abridged Pathway. This process is for Notified Class 23 and Licensed Class 4 medical devices.

Under the Abridged Pathway, the officials from the Thai Food and drug administration will evaluate the device without the need for the opinion from the experts on the outside due to the recognition from the reference agencies. But the Abridged pathway does not include the medical devices that have been specifically notified in the ministerial notifications or totally exempted from the assessment.

Specialized Regulatory Pathways for Medical Devices (Singapore & Malaysia)

Moreover, the overseas manufacturer will have an opportunity to utilize special regional reliance schemes in case the device is submitted to either Singapore or Malaysia registration. These medical devices regulatory pathways will assist in preventing the duplication of technical assessment in case of matching of documentation with the reference approval:

Reliance Scheme by Singapore HSA: It is related to Risk Classification 2, 3, and 4 (Class B, C, and D) for IVD and Non In Vitro Diagnostic devices. In order for it to be eligible under the Reliance scheme, all the technical information such as the brand name, model number, product code, intended use, and indications should be identical to those which have been approved by the Health Science Authority (HSA) of Singapore. The Thai FDA will then evaluate the device based on the HSA report.

Malaysia MDA Pilot Project: This scheme refers to Class 2 to 4 devices as well as Class 1 devices previously approved by Malaysia Medical Device Authority (MDA). Devices can be submitted to the Thai FDA through the Full Common Submission Dossier Template (CSDT) scheme without any further assessment conducted by any other experts in case the device was not exempted from safety, quality, and performance assessments by the MDA. The trade name, model, reference code, intended use, and indications should be completely identical to the Malaysian approved one.

Mandatory Technical Documentation Requirements

Submission files have to comply with the risk classification and selected regulatory routes for medical devices:

• Class I Medical Devices (Listed): Technical file submission shall contain a medical device label, IFU, specifications of the product, device description and characteristics, materials declaration, declaration of conformity, regulatory history of approval (if any), letter of authorization, and list of medical devices and group (grouped application). Sterilization report is mandatory for sterilized products, and calibration report is mandatory for measuring devices.

• Class II to IV Medical Devices (Abridged/Full/HSA Reliance): Technical dossier should contain the medical device label, IFU, executive summary, device description, summary of essential principles, summary of verification/validation, risk analysis, QMS certificate, declaration of conformity, letter of authorization, market history declaration, safety declaration, regulatory approval by reference agency (e.g., US FDA, EU NB, or HSA), list of medical devices and grouping, intended use/indications declaration, change notification(s), and manufacturer information on the postuse disposal and demolition methods.

• Details of the Reliance Program (HSA of Singapore): A participation letter for the Reliance program signed officially by the operator has to be submitted, the CSDT dossier that should be completely identical to the one filed with HSA, change notification documentation with respect to HSA (if any), the proof of current registration status in HSA, and the signed Thailand FDA & Singapore HSA Reliance Model Consent Form. The Singapore license holder has to email the consent form together with all MEDICS job reference numbers to HSA and upload it to the Thai FDA e submission portal officially requested.

Thailand Medical device registration Timelines and Certificate Lifecycle

• Review Timelines: Whereas a full review process normally takes an average of 150 working days on average, the use of Singapore HSA Regulatory Reliance Program shortens the process to 60 working days.

• Renewals: Listings are valid for 5 years. Application for renewal of registration should be done not more than 90 days before expiry. Operations may continue even after expiry date unless a rejection order is made. However, there is a grace period after expiry of 1 month in case valid reasons can be provided even though the penalty will continue. No application will be allowed after 1 month from expiry date.

• Modification and Change: Physical relocation or any other permanent modification of a registered manufacturing and storage facility should be preceded by an application. In the event of emergency relocation, the registrant can issue a written notification to the licensor within 5 days after relocation, and thus the new location becomes temporarily registered. The application for emergency relocation shall be made within no more than 90 days following the issuance of the notification. The other modifications that are permitted (change of the registrant's name, business operator, manufacturer controller, and device type) should be done via addendum.

• Cessation and Succession: Notice of closure of operations should be given within 30 days of cessation along with certificate and inventory of devices remaining. In case of death of a registrant, he has 90 days to show willingness to continue.

Statutory Fees and Cost Structure

Fees are split between initial establishment licensing and actual product registration pathways.

Establishment Licensing Cost Structure:

• License for Manufacturer Establishment: A total cost of 14,100 THB (100 THB for Application Fee + 12,000 THB for Inspection Fee + 2,000 THB for Certificate Fee).

• License for Importer Establishment: A total cost of 16,100 THB (100 THB for Application Fee + 1

Maximum Legal Caps for Statutory Issuance Fees (Baht):

• Establishment Registration: Manufacturing Certificate (10,000 Baht); Importation Certificate (20,000 Baht); Manufacturing License (100,000 Baht); Import License (200,000 Baht); Sales License (10,000 Baht); Advertisement License (10,000 Baht).

• Specifi cations and Listings: Manufacturing Specifi cations Receipt (50,000 Baht); Import Specifications Receipt (100,000 Baht); Manufacturing Listings Receipt (5,000 Baht); Import Listings Receipt (10,000 Baht).

• Application and Renewals: Licensing or Specifications or Listing Application (1,000 Baht per application); Renewal Fees are same as original full fee paid for certificate or receipt issuance except that manufacturing listings renewal is 2,500 Baht and import listing renewal is 5,00

Malaysia MDA  Thai FDA Pilot Project Special Fee Structure:

• Class 1 (Listed): Local Production (1,800 THB total); Import (3,100 THB total).

• Class 23 (Notified): Local Production (36,400 THB total); Import (49,000 THB total).

• Class 4 (Licensed): Local Manufacture (53,400 THB total); Import (74,000 THB total).

Note on Savings: Utilizing the Singapore HSA Reliance Program reduces registration costs by 53,000 Baht by waiving the expert review process fee.

Post Market Obligations and Quality Management Systems (QMS)

Foreign manufacturers are responsible for making sure that their local importers and entities adhere to the following postmarket requirements:

• Quality Management Systems: All production lines in general should meet GMP for Medical Devices according to Appendix A of ISO 13485:2016 or ISO 134852562. Nevertheless, in case compliance with the above stated requirements is not possible, all other production processes according to Appendix B should be implemented by 31 December 2026 (31 December 2027 for some existing facilities). Production of Class 1 medical devices and animal medical devices should comply with GMP according to Appendix C, Appendix A, or ISO 13485. In case the facility produces several devices with different risks, the QMS of the most risky device should be used in the facility.

• Quality Management Systems for Importer and Seller: Regulated under Good Importing Practices (GIP) or Good Selling Practices (GSP) which have 4 clauses (Management, Resources, Supply Chain/Specifications, and Surveillance). New registrants after 5 January 2025 must adhere to Clauses 2 and 3. For existing registrants, there will be a phased integration but will need to conform to Clause 1 to 4 by 1 January 2028.

• Operational Duties (Section 41): Registrants should have quality systems control, appoint an operational controller, keep records of the manufacturing/importing for inspection, have active complaint handling systems, and place physical signboards/certificates at the facility. Documentation that proves device safety and quality must be presented upon request from the licensor.

• Reporting Architecture for Adverse Events: It is legally binding on the entity to report any issues related to product defect or consumer’s adverse events and the field safety corrective action to the licensor irrespective of where the event happened.

Technical Criminal Penalties and Fines

• Unauthorized Activities in the Market: Manufacturing and Importation of Class 4 (Licensed Devices): Up to 3 years imprisonment or 300,000 Baht fine. Manufacturing and Importation of Classes 2 and 3 (Specified Device) devices: Up to 2 years imprisonment or 200,000 Baht fine. Manufacturing and Importation of Class 1 (Listed Devices): Up to 1 year imprisonment or 100,000 Baht fine. Sale without valid license and listing: Up to 12 years imprisonment, with fines of 100,000 to 200,000 Baht fine.

• Violations to Standards & Quality Control: Deviation from standards results in up to 3 years imprisonment and/or 300,000 Baht fine for licensed/declared devices; and 1 year imprisonment and/or 100,000 Baht fine for listed devices. Manufacturing/importation that does not conform with the particulars of the licence results in a fine up to 200,000 Baht.

• Fabrication of Recordkeeping: Preparing false records for the logbooks of sale, adverse events and complaints and falsification of technical documents: Up to 1 year imprisonment and/or 100,000 Baht fine for licensees; up to 6 months imprisonment and/or 50,000 Baht fine for registrants.

• Administrative Defaults: Continuing operation past expiration where there are pending new applications: 1,000 Baht per day fine for license holders and specification holders; 500 Baht per day fine for registrants and listings.

• Recall: In case of violation, or if a device does not comply with regulations, the Secretary General can mandate a total recall and destruction. The manufacturer, importer and vendor shall be fully responsible for any costs related to the process.

Medical Device Regulatory Consulting Services from Morulaa

 Through Morulaa HealthTech, your medical device regulatory consulting will be able to provide you with full Thailand Medical device registration service including all the necessary document preparations to ensure compliance with all the requirements of the Thai Food and Drug Administration. In that way, your products will get to the market in no time. Whether you are just entering the market in Thailand with your products or you already have products in other markets, you will find our medical device regulatory consulting an easy solution to all the regulations and requirements. We will make the whole process as simple as possible for you so you can know what is happening with your product at any given time.

Frequently Asked Questions