Thailand Medical Device Registration: Practical Answers on Licensing, Fees, Timelines and Post-Market Compliance

Thailand is the second largest medical device market in ASEAN, with more than 80 per cent of devices dependent on imports. The market is attractive, but four questions determine whether a project can be delivered: who holds the licence, how much it costs, how long it takes, and what happens on expiry.

1. Regulatory Framework and Classification

Q1. Which authority regulates medical devices in Thailand, and under what law?

The competent authority is the Thai Food and Drug Administration (Thai FDA / TFDA), which falls under the Ministry of Public Health. The division responsible for device registration, establishment licensing and post-market surveillance is the Medical Device Control Division (MDCD).

Q2. How many classes of medical device does Thailand use, and on what basis?

Thailand uses a four-class risk-based system (Class 1 to 4), aligned with the AMDD and applicable since 2021.

Classification factors taken into consideration:

• intended use and the claims made by the manufacturer;

• duration of contact with the human body;

• degree of invasiveness;

• whether the device contains energy (active devices);

• software risk level (SaMD).

• For IVD reagents, two further considerations apply: self-testing versus professional use, and the public health consequences of misdiagnosis.

Practical advice: classification is the first fork in market access and directly determines dossier depth, review duration and cost. For products near a class boundary, it is recommended to obtain a formal classification confirmation from the Thai FDA before investing in dossier preparation.

Q3. What is the difference between the registration routes?

There are three routes, with increasing levels of control. The respective certificate names are Listing Certificate, Notification Certificate and Product License.

Automatic approval for Class 1: from 15 January 2025, qualifying Class 1 devices on the Thai FDA Positive List are automatically approved upon submission through e-Submission and payment, without human review. Class 1 devices not on the list, and Class 1 devices with a measurement function, continue to undergo standard documentary review.

2. Licensing Structure and Holder Options

Q4. Can a foreign manufacturer hold the licence in Thailand itself?

No. Thai law requires that only a Thai entity established and registered in Thailand that holds an Establishment License — Importer may submit a product registration application, hold the registration certificate and handle importation. A foreign manufacturer cannot directly hold a Thai registration certificate.

An Establishment License is a permit for a Thai place of business, divided into importer and manufacturer categories. It is a prerequisite for holding a licence and for importation: any product registration application must be submitted by an entity that already holds the corresponding establishment licence.

Key points:

• granted only to companies duly established in Thailand, or to Thai nationals;

• an on-site inspection is required (the office and warehousing premises must comply with TFDA storage and quality system requirements), so inspection scheduling should be started early;

• valid for 5 years, renewed through SKYNET in the annual window of 1 October to 31 December.

Foreign manufacturers have three models for establishing presence in Thailand:

This is the single most consequential commercial decision in the Thai market, and it matters more than any technical detail. Choosing the wrong model costs far more to correct later than getting it right at the outset.

Q5. Should the licence be held by a distributor or by an independent licence holder?

The decisive criterion is who controls the registration certificate.

Inherent risks of distributor-held licensing:

• the certificate hangs in the distributor’s name, effectively locking the product registration number to that distributor;

• in the event of a commercial dispute or strategic adjustment, the certificate does not automatically follow the relationship;

• if the original holder refuses to sign a consent letter, the manufacturer generally has to submit a completely fresh registration application — repaying fees and waiting months or even a year, and potentially facing review against stricter current standards;

• there is a material risk of confidential technical documentation being leaked.

Advantages of the Independent Licence Holder (ILH / LAR) model:

• register once, then change distributors or appoint several at any time;

• avoids distributor lock-in on price and service;

• protects intellectual property and commercial channels;

• for manufacturers planning to cultivate the Thai market long term and who do not wish to be tied to a single dominant distributor, the ILH model is the more prudent initial structure.

Q6. Can one registration certificate cover multiple models, and what about multiple distributors?

Models: devices sharing the same trade name, the same Product Owner and the same intended use may be submitted in a single registration dossier.

Distributors: a product may have multiple holders or importers, but each entity must register the product independently, because only the holder may import and sell it. This means that the more distributors, the higher the initial registration cost.

This is precisely where the value of the independent licence holder model lies: the LAR acts as the primary holder, registering and importing, then supplying downstream distribution channels, so the manufacturer registers only once.

3. Technical Dossier and Quality System

Q7. What is CSDT, and what core technical data must Class 2/3/4 submit?

CSDT (Common Submission Dossier Template) is the ASEAN-harmonised medical device submission template. Thai Class 2 to 4 devices must be submitted in this format.

Q8. What are the quality system requirements (ISO 13485 / Thai GMP)?

Class 2 to 4: a valid ISO 13485 certificate (or Thai GMP certificate) must be provided. The certificate must cover both the legal manufacturer and the actual production site, and must be within its validity period. Providing an ISO 13485 certificate is generally accepted.

Class 1: must comply with Thai GMP guidance but is exempt from certification.

Holders and importers: must maintain GDPMD (Good Distribution Practice for Medical Devices) or an equivalent quality management system, and are subject to TFDA inspection.

Q9. When must clinical evaluation evidence (CER) be provided?

Class 4: a complete CSDT with clinical evidence is required. The Thai FDA’s review of clinical evaluation for high-risk products is becoming increasingly stringent, with detailed literature reviews or equivalent-device comparison reports required.

Class 2 and 3: clinical or performance data may be required depending on the nature of the device and the reference country approvals already held.

Digital health (SaMD): clinical evidence requirements for Class C and D products now approach the levels of EU MDR and the US FDA. For continuously learning AI-based algorithms, the locked version requirement and the post-market update strategy must be clearly defined.

Q10. What additional requirements apply to sterile devices?

In addition to the standard CSDT modules:

• sterilisation process validation report, for example ethylene oxide sterilisation (ISO 11135) or radiation sterilisation (ISO 11137);

• packaging validation;

• shelf life validation data;

• where applicable, a description of the disposal or destruction method.

4. Fees and Timelines

Q11. What are the official fees?

Renewal fees on importation:

• establishment licence: approximately 12,000 + 4,000 THB;

• Class 4: approximately 20,000 THB;

• Class 2 to 3: approximately 10,000 THB;

• Class 1: approximately 1,000 THB.

• Late payment attracts a daily penalty of approximately 500 to 1,000 THB depending on class.

Q12. How long does review take on each route?

Completeness check for electronic submissions: approximately 15 days. In practice, actual review cycles are generally faster than the officially stated periods.

Q13. Are there accelerated routes, and what is the Singapore HSA Reliance route?

Yes. The fastest available route is the Singapore HSA Reliance Route.

Prerequisites and mechanism:

• the device must already be approved and marketed in Singapore and be in a valid state on the Singapore medical device register;

• HSA shares its evaluation report or dossier directly with the Thai FDA, which then conducts an abridged evaluation.

Requirements:

• the CSDT submitted to the Thai FDA must be identical to the version submitted to HSA, including subsequent change notifications;

• a letter of consent between the Singapore registrant and the Thai FDA is required, authorising HSA to share its evaluation report.

Other available reference routes (Abridged / reference country route): the Thai FDA’s recognised reference agencies include the United States FDA, EU Notified Bodies, TGA (Australia), Health Canada, MHLW / PMDA (Japan), and WHO in vitro diagnostic prequalification. Class 2 to 4 devices approved by these agencies for a minimum period (normally more than one year) may apply for an abridged dossier.

A Malaysian registration also has a positive effect in Thailand, allowing exemption from expert review and accelerating registration.

5. Importation and Customs Clearance

Q14. What is LPI (License per Invoice), and why is it required for every shipment?

LPI, the License per Invoice, is a per-shipment import licence and the most distinctive and most frequently overlooked step in Thai medical device importation.

Common causes of customs delay:

• inconsistent HS code classification;

• fluctuations in declared goods value;

• late submission of the LPI;

• a single shipment mixing expired and valid products, which is generally not permitted to be cleared in part;

• a single shipment involving multiple legal manufacturers.

Q15. What additional approval is required for devices with Bluetooth or Wi-Fi?

Medical devices containing Bluetooth, Wi-Fi, cellular networking, RFID or other wireless technology require, in addition to Thai FDA registration, approval from the NBTC (National Broadcasting and Telecommunications Commission).

6. Post-Market Compliance

Q16. What are the adverse event reporting deadlines?

The deadlines for domestic events, under MoPH Notification B.E. 2563 (2020), are:

Supporting requirements:

• follow-up report after the initial report: within 30 days;

• overseas events: twice a year — events occurring from January to June are reported by the end of August of the same year, and events from July to December by the end of February of the following year;

• report to the Health Products Vigilance Center (HPVC) through its Medical Device Problem Reporting System, online or in person;

• reports must be completed in Thai on the official forms. English supporting evidence is acceptable, but the primary submission must be in Thai;

• the holder, whether manufacturer or importer, is fully responsible for PMS, vigilance reporting and labelling and advertising compliance.

Q17. How are FSCA and recalls reported?

An FSCA report is triggered when the product owner carries out any of the following actions, whether domestic or overseas: product recall, device modification, device replacement, device destruction, safety notice, or update and change.

Q18. What are the mandatory labelling and IFU requirements, including the 2025 changes?

Current basis: MoPH “Announcement on Principles, Procedures and Conditions for Labelling and Accompanying Documents for Medical Devices” B.E. 2568 (2025). It was signed on 27 November 2025, published in the Royal Gazette on 22 December 2025, and takes effect on 20 June 2026, replacing the B.E. 2563 (2020) rules.

Core change 1: language requirements now differ by intended use setting

Whether a device is designated home use or professional use is product specific and is determined at the classification and registration stage; it is not a unilateral decision by the manufacturer.

Core change 2: the grace period for applying Thai labels after import has been reduced from 180 to 120 days

Other key points:

• eight mandatory labelling elements: product name; intended use or indications; quantity or packaging specification; manufacturer or importer information (imported products must also show the country of origin and the importer); licence number or registration number; batch number or serial number; date of manufacture or expiry; and the method of calculating expiry;

• UDI: Class 2, 3 and 4 devices must bear a UDI where one exists;

• electronic IFU (e-IFU) is accepted: CD-ROM, QR code or website link are all permissible, but the content must include product name, detailed description, intended use, contraindications, directions for use, contact for enquiries or complaints, storage conditions, warnings and precautions, and the document version or latest revision date;

• changes require prior approval: the IFU may not be revised and placed on the market until a change application has been submitted to MDCD and approved;

• responsibility does not transfer: labelling compliance is the responsibility of the registrant and does not transfer to an appointed importer or distributor.

Q19. Can medical device advertising be placed directly?

No. Thailand operates a system of prior approval for medical device advertising.

Advertising directed at the public or at healthcare professionals must obtain an Advertising Licence Number before publication.

• the applicant must be the holder, being a Thai entity that holds the registration certificate or product licence; foreign companies must apply through their local authorised representative in Thailand;

• covered media are extensive: television, radio, print, outdoor, websites, social media, email marketing, brochures, video, trade show stands, paid search advertising;

• advertising content must be consistent with the approved intended use and labelling. Claims beyond the registered indications will not be approved, and a registration change must be made first.

Trade show exemption (announcement of 2 September 2025): advertising of devices at national or international scientific conferences (of 100 persons or more) and academic conferences is exempt from prior permission. The organiser must notify the Thai FDA in advance of the event and the exhibits, and the content must not contain false or exaggerated claims, endorsements, prize draws, or prohibited disease-related claims.

Enforcement has increased markedly since the 2019 amendment. The MDCD now works with the Electronic Transaction Development Agency (ETDA) to monitor Thai-language digital channels, and may require platforms to take content down.

Q20. How long is the registration certificate valid, and how do renewal and holder transfer work?

Renewal:

• from July 2025 the Thai FDA established a unified renewal system, handled through SKYNET;

• window: 1 October to 31 December each year, submitted in the year the certificate expires;

• Full CSDT route: no additional documents; renewal is automatic on payment of the fee (HIV test kits are the exception and require an analytical report);

• Partial 1 / Partial 2 route: supplementary documents must be submitted according to adverse events in the past 5 years. Where there were no serious adverse events, a safety statement to that effect is submitted; where there were, the safety statement, RMP 1/2 report, RMP 3 report and product analysis report must be submitted.

• non-renewal in time: the registration becomes invalid, SKYNET closes the import clearance channel for that entry, and the product cannot be cleared.

• late completion is possible within one month after expiry, up to 31 January, with a statement of reasons and payment of the daily penalty.

Transfer of holder / transfer of the registration certificate:

Under the announcement of 19 September 2024, effective 20 September 2024, a unified transfer process has been established for Class 2 to 4.

Preconditions:

• the dossier to be transferred must be a Full CSDT (a Partial dossier must first be completed to Full);

• a written letter of consent from the original holder;

• a Declaration of Identicality and a Safety Declaration;

• the device before and after transfer must be from the same manufacturer and the same Product Owner;

• the original registration certificate must be valid.

Process: submitted through e-Submission; the Thai FDA aims to complete the transfer within approximately 2 months. On approval of the transfer a new registration number is issued, and the original holder must cancel the original certificate within 30 days.

Cases where transfer will not be granted: the device has a history of serious adverse events, or there are reasonable concerns as to its quality, performance or safety.

7. Principal Legal and Regulatory References

8. Three Compliance Risks Most Often Underestimated

1. Choosing the wrong licence holder. Handing the registration certificate to a distributor is equivalent to handing over control of the market; if the holder later changes, the manufacturer may be forced to register again from scratch.
2. Missing the renewal window. The window of 1 October to 31 December each year is hard. If it is missed and the certificate expires, the import channel is closed. This is a fixed task that must be entered into the company compliance calendar; it does not roll over automatically just because the product has had no problems.
3. Retroactive remediation of labelling and advertising. Thailand applies strong regulation over labelling language and advertising permissions, and enforcement continues to tighten. Artwork and advertising materials should be brought into compliance review at the start of the project schedule rather than at the last moment.

Recommendation for Chinese manufacturers: before entering the Thai market, address three things first — classification confirmation, licence holder structure design, and the post-market compliance calendar. Getting these three right provides a stable foundation for the subsequent registration, importation and renewal.