Thailand is renowned for its stunning landscapes, rich culture, and world-class healthcare. The country has been steadily growing as a hub for the medical device industry in Southeast Asia. If you are a manufacturer or distributor looking to bring your medical devices into this promising market, it's crucial to understand the regulatory framework and the medical device registration process in Thailand. In Thailand, the Food and Drug Administration (FDA) is responsible for overseeing the registration and regulation of medical devices. The FDA ensures that all medical devices imported and distributed in Thailand meet safety, quality, and efficacy standards.
Medical devices manufactured or imported into Thailand may serve either commercial or non-commercial purposes. For medical devices manufactured with in Thailand or imported into Thailand for commercial purposes, there are three distinct review pathways available to secure approvals from the Thai FDA:
Medical Device Registration via Full Evaluation Route
The manufacture or importation of medical devices in Thailand for commercial use necessitates the acquisition of the following:
Establishment Licensing for Manufacturing or Importing
Product Registration for Manufacturing or Importing
If an applicant is uncertain whether their product qualifies as a medical device, they have the option to submit a Product Classification Application to the Agency for clarification. This helps ensure accurate categorization and adherence to regulatory requirements.
Anyone intending to engage in the manufacturing or importation of medical devices must complete the establishment registration process with the Thai FDA. This step is a fundamental requirement to ensure compliance with regulatory standards.
Once the Establishment license has been obtained as a prerequisite, the manufacturer or importer must initiate the product registration process. The initial step in the medical device registration process involves classifying the medical device into a specific risk category. Depending on this classification, the medical device will either be listed for low-risk devices or notified in the case of low-moderate and moderate-high risk devices. Class 4 high-risk devices are subject to rigorous scrutiny and must receive licensing from the Thai FDA. It's important to note that the documentation requirements and review timelines differ for Listed, Notified, and Licensed Medical devices, corresponding to their respective risk classifications.
The applicant is required to submit the application along with the requisite documentation and the applicable review fees. The specific fees are determined based on whether the device falls into the listed, notified, or licensed category, each having its own corresponding fee structure.
Documentation requirements for Listed, Notified and Licensed Medical Devices
The Thai FDA conducts an initial review of the submission to ensure its completeness and accuracy. In contrast to the procedures of many other global regulatory agencies, applicants in this case are required to make payments at two separate stages. The f
irst payment is made during the application submission, and the second payment occurs once the review process has been successfully completed.
When seeking to renew the certificate of a Notified or licensed medical device, the registration holder must submit an application for renewal prior to the certificate's expiration date. This application should be accompanied by the certificate of the Listed, Notified, or licensed medical device, as well as any necessary information, documentation, or supporting evidence as specified in the application form. Additionally, the renewal fee should be included with the submission. This ensures the seamless continuation of certification for the medical device.
In the event of the certificate of a Listed, Notified, or licensed medical device being lost, damaged, or destroyed, the registrant is obligated to submit an application for a replacement certificate of the licensed medical device to the licensor within fifteen days from the moment the loss, destruction, or damage is acknowledged. Additionally, it is mandatory to return the damaged certificate of the licensed medical device, or if applicable, provide a police report concerning the loss or destruction of the said certificate, to the licensor. This process ensures the timely issuance of a replacement certificate.
The Thai FDA allows for modifications to be made to the Notified or licensed medical devices. These amendments may pertain to either the establishment license or the product registration. However, when it comes to changes in the establishment registrant's name and/or alterations to the name or address of the facility engaged in the manufacturing or importation of medical devices, the registrant can only make amendments to the certificate after the necessary adjustments have been approved in the medical device manufacturing or importing establishment license.
When seeking amendments to the certificate of the licensed medical device, the registrant is required to submit an application for the modification of the approved items within the certificate. This application should be accompanied by the pertinent information, documentation, or evidence related to the items slated for amendment. Additionally, other required documentation or evidence as specified in the "Application for Amendment to Approved Items in the Certificate of Licensed Medical Device" form should also be included in the submission. This comprehensive approach ensures that any changes are processed efficiently and accurately.
Medical Device Registration via Concise Pathway
The Concise pathway is an expedited approach for the registration of Class 2, 3, and Class 4 medical devices that leverages approvals from recognized reference agencies. This streamlined process is designed to accelerate registration and reduce evaluation fees. To qualify for the Concise pathway, medical devices must have undergone full evaluation and have been on the market for over one year without any significant adverse events as reported by any of the Reference Regulatory Agencies.
The Regulatory Health Authorities acknowledged by the Thai FDA for the concise pathway include:
European Union Notified Bodies (EUNB)
Japan Ministry of Health Labour and Welfare (MHLW)
Therapeutic Goods Administration (TGA)
US Food and Drug Administration (FDA)
WHO Prequalification for In-Vitro Diagnostic Devices (IVDs)
For medical devices to be eligible for the concise pathway, they must share the same trade name, model, product code, intended use, indications, label, IFU (Instructions for Use), packaging, and the name and address of the physical manufacturer as those approved by the reference agency. This consistency in product details ensures a smoother and expedited registration process.
Medical Device Registration via Reliance Program
The Reliance program offers an evaluation pathway for Class 2, 3, and 4 medical devices or Class B, C, D, relying on the approval granted by the Health Science Authority (HSA) in Singapore. This initiative is geared towards expediting the registration process and reducing evaluation fees. To be eligible for consideration under this program, the medical device must have obtained approval from HSA. Additionally, the trade name, model, product code, intended use, indications, label, IFU (Instructions for Use), packaging, and the name and address of the physical manufacturer submitted through the reliance pathway must be identical to what was approved by HSA.
For participation in the Reliance Program, the applicant is required to submit the following documentation:
The same CSDT (Common Submission Dossier Template) registration dossier submitted to HSA, Singapore.
In the event of any post-approval changes made to the medical device, the change notification document approved by HSA, Singapore.
A letter requesting a participation form to join the regulatory reliance program between Thailand FDA and Singapore HSA.
Evidence of approval from Singapore.
A mutual consent form for the regulatory reliance program between Thailand FDA and Singapore HSA.
These documents facilitate a smooth and efficient registration process through the Reliance Program.
Medical Devices manufactured or imported for non-commercial purposes
Medical Devices intended for any of the non-commercial purposes listed below are exempt from the registration requirements discussed in this blog. If your business scenario aligns with any of the following situations, it is advisable to seek guidance from a regulatory expert to navigate the specific regulatory prerequisites.
The production, import, or sale of medical devices by governmental agencies as part of their duties related to disease prevention, diagnosis, treatment, rehabilitation, and the operations of the Thai Red Cross Society.
The fabrication of medical devices solely intended for sterilization purposes within medical facilities under the regulations outlined in the law governing such establishments.
The production or sale of medical devices crafted by medical and public health professionals for their individual patients or animals.
The sale of medical devices, for which a license, specification declaration certificate, or notification certificate has been issued, by medical establishments or medical and public health practitioners, intended for their individual patients or animals.
The production or import of medical devices in quantities necessary for personal use, as samples, for exhibition, or for research, analysis, and quality and standards testing purposes.
The import of medical devices exclusively for individual patients or animals.
The manufacturing of medical devices as samples designated for export.
The production or import of medical devices in compliance with the rules, procedures, and conditions as stipulated in the Minister's Notification with recommendations from the Commission.
Navigating the medical device registration process in Thailand can be challenging due to the stringent regulatory requirements. It's essential to work with local experts and ensure your device's classification is accurate. Understanding the specific requirements and pathways will help streamline the registration process and open doors to the growing healthcare market in Thailand.
Ready to navigate the intricate world of medical device registration in Thailand or explore the regulatory Programs in more detail? Contact Artixio's experts today for comprehensive guidance and assistance. We're here to help you streamline your registration process and reduce evaluation fees. Don't hesitate – reach out to us now!