Thailand Medical device registration overview

For Thailand Medical device registration, the Medical Device Control Division (MDCO) of the Thai Food and drug administration (FDA) regulates medical devices. The agency has updated its regulatory requirements and approval processes. Thailand offers a massive market for medical devices, but getting approved by the local FDA can be involved.

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

The target market (Thailand) categorizes medical devices into four risk-based classes aligned with the ASEAN Medical Device Directive (AMDD), and these regulatory pathways for medical devices dictate the specific market entry control pathway and pre-market requirements:

• Class 1 (Low Risk): Regulated as Listed Devices under Section 6(1)(c). Manufacturers or importers must obtain a Listing Receipt before operations. Listing Receipts remain valid until the 5th year from the date of issuance.

• Class 2 (Low-Moderate Risk) & Class 3 (Moderate-High Risk): Regulated as Notified Devices (or Specifications Declared Devices under Section 6(1)(b)). Importers or manufacturers must obtain a Specifications Declaration Receipt.

• Class 4 (High Risk): Regulated as Licensed Devices under Section 6(1)(a), requiring a full Medical Device Licence prior to commercialization.

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

For European companies holding a CE mark from European Union Notified Bodies (EU NB) and US companies holding US Food and Drug Administration (US FDA) approvals, the target market offers an expedited entry route known as the Abridged Pathway. This pathway applies to Notified (Class 2 to 3) and Licensed (Class 4) medical devices.

Under the Abridged Pathway, Thai Food and drug administration officers conduct an expedited assessment instead of requiring a full evaluation by external experts, leveraging the prior approvals from these recognized reference agencies. However, this pathway explicitly excludes medical devices that are subject to specific ministerial notifications or those completely exempted from quality, efficacy, and safety assessments (such as Listing or Exempted product approvals).

Specialized Regulatory Pathways for Medical Devices (Singapore & Malaysia)

Overseas manufacturers can also utilize specific regional reliance frameworks if their devices are registered in Singapore or Malaysia. These regulatory pathways for medical devices may reduce duplicated technical review when documents match the reference approval:

Singapore HSA Reliance Program: This program covers Risk Classifications 2, 3, and 4 (Classes B, C, and D) for both In Vitro Diagnostic (IVD) and Non-In Vitro Diagnostic devices. To qualify, all technical parameters including trade name, model, product code, intended purpose, and indications for use submitted to the Thai FDA must be completely identical to those approved by the Health Sciences Authority (HSA) of Singapore. The Thai FDA evaluates the device by relying directly on the HSA evaluation report.

Malaysia MDA Pilot Project: This framework applies to Class 2 to 4 devices, as well as Class 1 devices already approved by the Malaysia Medical Device Authority (MDA). Devices can be submitted via the Full Common Submission Dossier Template (CSDT) pathway to the Thai FDA without re-evaluation by external experts, provided the device has not been exempted from safety, quality, or performance evaluations by the MDA. The device’s trade name, model, reference code, intended use, and indications must be entirely identical to the Malaysian approved version.

Mandatory Technical Documentation Requirements

Submission files must be maintained according to the risk classification and chosen regulatory pathways for medical devices:

• Class 1 Medical Devices (Listed): The technical file submission must include the medical device label, instructions for use (IFU), product specifications, device description and features, material declaration, declaration of conformity, regulatory approval history (if applicable), letter of authorization, and a list of medical devices and grouping (for grouped applications). A sterilization report is mandatory for sterilized devices, and a calibration report is mandatory for devices with a measuring function.

• Class 2 to 4 Medical Devices (Abridged/Full/HSA Reliance): The technical dossier requires a medical device label, IFU, executive summary, device description, essential principle summary, summary verification and validation, risk analysis, quality management system (QMS) certificate, declaration of conformity, letter of authorization, market history declaration, safety declaration, approval evidence from a reference agency (such as the US FDA, EU NB, or HSA), a list of medical devices and grouping, an intended use/indication declaration, change notifications, and a manufacturer information document describing post-use methods of disposal, demolition, or waste management.

• Reliance Program Specifics (Singapore HSA): Operators must submit a formal signed participation request letter, the CSDT dossier (completely identical to the one submitted to the HSA), HSA change notification documents (if any), proof of active HSA registration, and a signed Thailand FDA & Singapore HSA Reliance Model Consent Form. The Singapore license holder must email this consent form with all MEDICS job reference numbers to the HSA, and upload an identical copy to the Thai FDA e-submission system upon official request.

Thailand Medical device registration Timelines and Certificate Lifecycle

• Review Timelines: While a standard full evaluation pathway requires an average of 150 working days, utilizing the Singapore HSA Regulatory Reliance Program reduces the review timeline down to 60 working days.

• Renewals: Listing receipts are valid for 5 years. Renewal applications for registrations must be submitted no later than 90 days prior to expiration. Operations may provisionally proceed past expiration until a rejection order is finalized. A late renewal grace period is permitted up to 1 month post-expiration if valid reasons are provided, though ongoing daily late penalties still apply. Applications are strictly barred after 1 month post-expiration.

• Modifications and Changes: Any physical relocation or permanent change to a registered manufacturing or storage facility requires a prior application. However, an urgent or temporary relocation allows the registrant to submit a written notice to the licensor within 5 days of moving, which provisionally registers the new location. The formal relocation application must then be submitted within a maximum of 90 days from the initial urgent notice. Other permissible amendments (such as changes to registrant name, business operator, manufacture controller, or scope of devices) must be formally approved and appended as an addendum.

• Cessation & Succession: Written notice of closing operations must be served within 30 days of cessation, alongside the physical certificate and a declared inventory of remaining medical devices. Upon the death of a registrant, an heir has 90 days to express intent to continue operations.

Statutory Fees and Cost Structure

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

Establishment Licensing Cost Structure:

• Manufacturer Establishment License: Total of 14,100 THB (100 THB Application fee + 12,000 THB Inspection fee + 2,000 THB Certificate fee).

• Importer Establishment License: Total of 16,100 THB (100 THB Application fee + 12,000 THB Inspection fee + 4,000 THB Certificate fee).

Maximum Legal Caps for Statutory Issuance Fees (Baht)

• Establishment Registration: Manufacturing Certificate (10,000 Baht); Importation Certificate (20,000 Baht); Manufacturing Licence (100,000 Baht); Import Licence (200,000 Baht); Sale Licence (10,000 Baht); Advertising Licence (10,000 Baht).

• Specifications & Listing Receipts: Manufacturing Specifications Receipt (50,000 Baht); Import Specifications Receipt (100,000 Baht); Manufacturing Listing Receipt (5,000 Baht); Import Listing Receipt (10,000 Baht).

• Applications & Renewals: Licence/Specification/Listing Application Fee (1,000 Baht per issue); Renewal Fees are equal to the original full price of the initial certificate or receipt issue (except for Manufacturing Listing Renewal at 2,500 Baht and Import Listing Renewal at 5,000 Baht). Amending a licence costs 1,000 Baht, and amending a specifications receipt costs 500 Baht.

Malaysia MDA - Thai FDA Pilot Project Special Fee Structure

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

• Class 2 to 3 (Notified): Local Manufacture (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)

Overseas manufacturers must ensure their local importers and entities comply with strict post-market rules, including Quality Management Systems duties:

• Manufacturer Quality Management Systems: General manufacturing lines must comply with GMP for Medical Devices specified in Appendix A, ISO 13485:2016, or ISO 13485-2562. If compliance is unfeasible, alternative processes under Appendix B must be integrated by the final deadline of 31 December 2026 (or 31 December 2027 for certain existing facilities). Class 1 and animal medical devices must comply with Appendix C GMP, Appendix A GMP, or ISO 13485. If a facility produces devices across varying risk levels, the QMS of the highest risk device must be implemented across the entire facility.

• Importer and Seller Quality Management Systems: Regulated under Good Importing Practices (GIP) or Good Selling Practices (GSP), consisting of 4 clauses (Management, Resources, Supply Chain/Specifications, and Surveillance). New registrants after 5 January 2025 must immediately comply with Clauses 2 and 3. Existing registrants face a staggered integration but must achieve full multi-clause compliance (Clauses 1 to 4) by the definitive milestone of 1 January 2028.

• Operational Duties (Section 41): Registrants must maintain quality systems control, appoint an operational controller, keep detailed manufacturing/importing logs for official inspection, maintain active recorded complaint handling systems, and display physical signboards and certificates visibly at the facility. Technical documentation verifying safety and quality must be surrendered upon official request.

• Adverse Event Reporting Architecture: Entities are legally mandated to report device defects, consumer adverse events, and field safety corrective actions to the licensor, regardless of whether the event occurred domestically or internationally.

Technical Criminal Penalties and Fines

• Unlicensed Market Activity: Manufacturing or importing Class 4 (Licensed) devices without a license carries up to 3 years imprisonment and/or a fine up to 300,000 Baht. Doing so for Class 2 to 3 (Specification-declared) devices carries up to 2 years imprisonment and/or a 200,000 Baht fine, while Class 1 (Listed) devices carry up to 1 year imprisonment and/or a 100,000 Baht fine. Selling devices without the proper license or listing carries up to 1 to 2 years imprisonment and fines between 100,000 and 200,000 Baht.

• Standard & Quality Violations: Deviating from safety standards carries up to 3 years imprisonment/300,000 Baht fine for licensed/declared devices, and up to 1 year imprisonment/100,000 Baht fine for listed devices. Manufacturing or importing items not in accordance with their granted licence particulars carries a straight fine up to 200,000 Baht.

• Falsification of Records: Preparing false records for sales logs, adverse events, complaints, or falsifying technical documentation carries up to 1 year imprisonment and/or a 100,000 Baht fine for licensees, and up to 6 months imprisonment and/or a 50,000 Baht fine for registrants.

• Administrative Delinquency: Operating post-expiration while renewal applications are pending subjects licenses/specification providers to ongoing daily fines of 1,000 Baht per day, and registrants/listing persons to 500 Baht per day.

• Recalls: If a device fails to meet regulatory standards or is found unsafe, the Secretary-General can mandate a complete product recall and destruction. The manufacturer, importer, or vendor is completely liable for all associated recall and destruction expenses.

Medical Device Regulatory Consulting Services from Morulaa

At Morulaa HealthTech, our medical device regulatory consulting services handle your entire Thailand Medical device registration process from start to finish. We handle all the paperwork for you so you can be sure you meet every Thai Food and drug administration requirement. This way you can get your products to market fast. If you are just starting to sell your products in Thailand or if you have products around the world, our medical device regulatory consulting services make it easy for you to follow all the rules and regulations. We make the whole process simple and easy to understand so you know what is going on with your products at all times. These medical device regulatory consulting services also support classification, dossier preparation, and submission planning for Thailand market entry.

Frequently Asked Questions