Thailand medical device classification. 2551 (2008) and its amendments (2 nd Edition, 2019).

Thailand medical device classification Learn about classification, regulatory steps under Thai FDA rules. . The Thai FDA registration process and the Thailand medical device classification process are pivotal points that every manufacturer needs to comprehend and adhere to before entering into the medical device market in Thailand. Whether you’re a new player or a global brand, we handle the regulatory Aug 6, 2021 · The Thai Food and Drug Administration (TFDA) has revised its medical device regulations to ensure the safety and effectiveness of the devices marketed in Thailand and to harmonize the regulations with the other ASEAN countries. Our experienced regulatory affairs specialists provide comprehensive support, from initial classification Dec 24, 2024 · On November 22, 2024, the Thai FDA published an infographic on its official website, providing clarity on the classification of vehicles and medical equipment as medical devices under Thailand's Medical Device Acts. With this new regulation Importer and Distributor: Local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA's manual of medical device classification. Feb 20, 2025 · Learn about Thailand medical device registration process with OMC Medical Limited, guiding you through regulatory requirements for a smooth market entry. Thailand’s medical device registration requirements follow different processes according to the product’s classification and whether it is a new registration or an already registered medical device in Thailand. Thailand Medical Device Classification As per the old regulations, medical devices were classified into three (3) Classes – General, Notified and Licensed medical devices corresponding to Class III, II and I respectively. Medical devices renewal is divided into 2 groups as follows: A). Feb 10, 2025 · The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. Learn how this impacts regulatory compliance and market access. DEFINITIONS ACTIVE MEDICAL DEVICE: Any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical device classification in Thailand Based on risk and ASEAN MDD guidance, medical devices ASEAN AGREEMENT ON MEDICAL DEVICE DIRECTIVE The Governments of Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Republic of the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Viet Nam, Member States of the Association of Southeast Apr 25, 2025 · On March 18, 2025, the Thai FDA released a draft regulation to amend labeling and IFU requirements for medical devices. 2563 dated 31 January 2020. May 7, 2024 · Categorization and Criteria: Under the updated guidelines, medical devices are categorized into two distinct groups: those with specific announcements and those without. This marked a milestone for both establishments and the Thai F Importer and Distributor: Local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA's manual of medical device classification. Feb 26, 2021 · New Medical Device Classification System The new regulations transition to a risk-based classification system based on ASEAN MDD guidance. Pure Global simplifies the process with AI workflows that accelerate TFDA submission preparation, along with Aug 12, 2025 · In Thailand, medical device regulation falls under the jurisdiction of the Medical Device Control Division (MDCD), part of the Thai Food and Drug Administration Medical Device Registration in Thailand Class I devices must be registered with the Regulatory Authority, therefore it is necessary to submit the required documentation in the Common Submission Dossier Template (CSDT) format which will be subject to an in-depth revision. Medical devices whose import permit need to be amended to comply with the risk-based classification Medical Device registration at the Thai FDA is regulated by the new Medical Device Act issued in 2019, followed by the new Medical Device classification issued in 2021. With Thailand’s growing demand for advanced medical technologies, especially in diagnostics, surgical equipment, and digital health, the opportunities are significant. That’s where Andaman Medical comes in. Officially transits from policy-based classification to risk-based classification starting from Feb 15, 2021. Manufacturers, or their local license holders, will now proceed directly with full registration applications through the Thai FDA E-submission system. So, the set of medical devices under each classification after Mar 14, 2023 · Read about Thai FDA document requirements for Thailand medical device registration and the approval path/timeline for each device classification category. Nov 22, 2022 · The Medical Device Control Division, Thai FDA of the Ministry of Public Health has issued Classification of Notification Medical Device (Class B and Class C) No. With this new regulation, all physical therapy products will be classified as either Class A, B or C medical devices, requiring Notification from the Thai FDA. Feb 10, 2025 · On January 15 th, the Thai FDA implemented an auto-approval process for low-risk listing medical devices (Class 1) under the Positive List application. We summarized all the criteria of risk considered by Thai FDA, and for each risk factor we report (in second column) the effective classification based on the usage/application. Concise Pathway: CLASS 2-4 Medical Devices registered and marketed for more than 1 year Therapeutic Goods Administration: TGA Health Canada: HC European Union Notified Bodies: EU NB Japan Ministry of Health Labour and Welfare: MHLW WHO Prequalification of in Vitro Diagnostics (IVD) US Food and Drug Administration: US FDA Thai FDA-HSA Reliance pathway since 2019: CLASS 2-4 Medical Devices that Further Steps for Manufacturing or Importing a Medical Device for Commercial Purposes in Thailand (Before proceeding, make sure you've read Steps 1–2 to check product classification and identify the purpose of import/manufacture. Many medical Aug 2, 2021 · As part of the transition of risk-based classification, the Thai FDA published an updated Announcements regarding Criteria, Methods, and Conditions for Medical Device Manufacturing, Importation, and Distribution Record or Report Preparation. Medical Device registration in Thai FDA, is regulated by the new Medical Device Act issued in 2019, followed by the new Medical Device classification issued in 2021. The TFDA often chooses applications that feature novel technology or new indications for use within Thailand for such reviews. In a move to bolster safety standards, Thailand's Ministry of Public Health has announced a significant update to its dental medical device regulations. Learn documentation requirements and impacts on IVD & non-IVD devices. Steps for Manufacturing or Importing a Medical Device in Thailand Step 1: Check whether your product is considered a medical device under Thai regulations Not sure if your product is a medical device? You can submit an application to the Thai FDA to determine whether it falls under the definition of a medical device. Oct 11, 2022 · Medical Device Act 2nd Edition BE 2562 (2019) (Eng Version) 11 ตุลาคม 2022 RA News Sep 13, 2024 · Any registration that does not correspond to the medical device risk classification category is deemed affected to the consumers’ health and safety. Nov 17, 2025 · Understand how to register and import medical devices in Thailand. Medical Device Control Division, Food and Drug Administration was officially established in June 1990 as regulatory authority to control manufacture, import, sale and advertise medical devices in Thailand. Governed by the Thai Food and Drug Administration (TFDA) under the Ministry of Public Health, the country has established a structured and evolving regulatory framework. Existing physical therapy products with Jan 29, 2024 · The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS®). Medical devices manufacturers need approval from the Thai FDA and a Local Authorized Representative (LAR). While classification rules closely align with the ASEAN MDD guidance, the Thai FDA has also included specific rules for each registration route. ) Step 3 : Establishment Licensing Anyone who wishes to manufacture or import medical devices for commercial purposes must register their establishment with the Thai May 9, 2018 · Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive. As always, we commend the Thai Food and Drug Administration (Thai FDA) for its work towards aligning the new medical device regulations in Thailand with the ASEAN Medical Device Directive (AMDD). It is a requirement before market access. May 20, 2025 · Thailand has implemented a risk-based classification system for medical devices manufactured within its market. Salient points are summarized below: 1) Withdrawal of previous Ministry of Public Health Announcement regarding Criteria, Methods, and Conditions for Emergo by UL can assist you in determining the correct medical device risk classification according to Health Science Agency (HSA) registration routes. Dec 27, 2022 · In conformity with the “Ministry of Public Health regarding Medical device categories shall be registered under notified medical device B. Full CSDT dossiers get auto-renewal, while Partial pathways require safety declarations and select documents. Thailand’s existing medical device registration portal now supports online submission for risk classification and grouping confirmation. A license transfer may be needed when there is a change Apr 8, 2022 · On April 4, 2022, the Thai FDA released updated review timelines for medical device applications submitted through the e-submission portal. To ensure effective regulation, medical devices in Thailand are classified into four risk-based categories, as shown in the diagram below. Each class has its own level of regulatory scrutiny, including requirements for quality certification, safety data, and documentation. 2563 (2020)“, therapeutic medical devices are classified under Listing (Class1 medical device). Thailand medical device regulation, Thailand medical device approval and registration, Thailand MDCO, Thai FDA, Thailand medical device classification. Wiselink Group, with its internal Regulatory Department, guarantees a positive certification Nov 4, 2024 · On September 19 th, 2024, the Thai FDA published a notification (Thai, English) updating guidelines to provide a systematic process for transferring medical device licenses for importers and manufacturers, covering devices classified from Class 2 through Class 4 (Guidelines document with Thai version at the top and English at the bottom). The […] THAI MEDICAL DEVICE REGULATION 2021: NEW THAI FDA RULES ON THE CLASSIFICATION AND REGISTRATION OF MEDICAL DEVICES As announced in November and anticipated in a recent article, Thai FDA has implemented the new procedures for the registration of Medical Devices in Thailand. May 15, 2022 · All medical devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class C, Unless they are implantable or long-term invasive medical devices, in which case they are in Class D. Medical device manufacturers will still have to submit all the same data and fees and will then immediately receive a registration number upon submission. Jan 24, 2023 · On 09 December 2022, the Thai FDA issued a clarification on the Classification of Notification Medical Device (Class B and Class C) No. Feb 20, 2025 · The Thai FDA has reintroduced the auto approval system for Class 1 medical devices, streamlining registration for eligible products listed in the Positive List. THAI MEDICAL DEVICE REGULATION 2021: NEW THAI FDA RULES ON THE CLASSIFICATION AND REGISTRATION OF MEDICAL DEVICES As announced in November and anticipated in a recent article, Thai FDA has implemented the new procedures for the registration of Medical Devices in Thailand. This information provides an important reference for Chinese medical device manufacturers to enter the Thai market. 2551 and its… Nov 7, 2024 · The Thai Food and Drug Administration (FDA) has reissued Guidelines for Determining Health-Type Software Products to help medical device registrants obtain accurate classification information. This is a testimonial of the efforts put in place by Thai FDA to converge and harmonize with regulatory requirements for the registration of medical devices to facilitate patient access in the Asia Jul 18, 2018 · Navigating the regulatory approval process for medical devices and in vitro diagnostics (IVDs) in Thailand is essential for successful market entry. Medical Devices Registration in Thailand is done with the Thai Food and Drug Administration (FDA). Thailand employs a four-tiered risk-based classification system (Class 1-4) and strictly follows the recommendations of the ASEAN Medical Device Directive Aug 28, 2024 · The Thai FDA announced (June 5) that the technical documentation required for Class 2, 3 and 4 medical device registration has been reduced to lessen the regulatory burden to the industry, as well as reduce redundancy in the required documentation. 2551 (2008) and its amendments (2 nd Edition, 2019). AMDD Covers Article 3: EPSP Article 4: Classification of Medical Devices Article 5 : Conformity Assessment Article 6 : Registration and placement on the Market Article 7 : Licensing of Person Responsible for placing medical devices on the markets of member states Article 8 : Technical Documents for medical devices Article 9: Reference to Technical Standard Article 13: Clinical Investigation Further Steps for Manufacturing or Importing a Medical Device for Commercial Purposes in Thailand (Before proceeding, make sure you've read Steps 1–2 to check product classification and identify the purpose of import/manufacture. 2551 and its amendments, which were adjusted according to the ASEAN Medical Device Directive, there have been more updates on the medical device regulations under the Thai Food and Drug Administration (FDA). And for In-vitro medical device, the product is classified from class 1 to May 29, 2024 · Medical devices are a key element of patient diagnosis and treatment. Singapore medical device registration, regulation, approval process, regulatory requirements HSA Singapore Medical Device Authority. They could be basic diagnostic tools like tongue depressors and thermometers or complicated, curative implantation like heart valves and coronary stents. With the enforcement of a pivotal announcement—namely, "Criteria, Methods, and Conditions in Selling Dental Medical Devices, 2024"—the nation's dental healthcare landscape is poised for a Jun 17, 2024 · On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand. Learn about new licensing, advertising, cybersecurity measures, and compliance requirements to streamline registration and ensure device safety in Thailand. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. Dec 27, 2023 · Ensure that all documents adhere to the Thai FDA’s specified format and content requirements. (Draft) Ministerial regulation on the Rules, Procedures, and Conditions on the Use of Medical Devices in Clinical Trials. Jul 3, 2021 · Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B. Oct 5, 2024 · Understanding the classification of IVD medical devices is crucial for compliance and successful registration in Thailand. Manufacturers looking to assess the probability of their application being selected for a Specialist Review should Oct 1, 2024 · Classification System In recent years, Thailand has made significant progress in harmonizing its medical device regulations with the Association of Southeast Asian Nations (ASEAN) Medical Device We would like to show you a description here but the site won’t allow us. Jun 4, 2025 · Thailand’s FDA has launched a new CSDT Fulfillment system to support medical device dossier upgrades for license transfers and referrals. 2551 shall be repealed and replaced by the following provisions: “(1) medical device grouping or medical device classified by its hazardous risk to health, body or life of human beings or animals or its impacts on the public health, as well as the rules, procedures and conditions for the manufacture or import of New Medical Device Regulations in Thailand On February 15 th the Thai FDA published significant new guidance governing the classification, common submission dossier template requirements, fee schedule and transition plan for medical device registration. Mar 26, 2021 · The new Thai Medical Device Regulation 2021: New rules on the classification and registration fo Medical Devices in Thailand. Jun 16, 2021 · Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B. The new regulation entered into force on February 15, 2021 (Class 2,3,4) and March 17, 2021 (Class 1). Mar 1, 2022 · Risk management plan: consists of the scope of risk management at which stage life cycle of the medical device, intended use and the details of the operation of the medical device, role and responsibility of the risk management team, risk tolerance criteria, the work plan for collecting production and post-production information. Thailand FDA Medical Device Registration Thailand stands as a leading hub for medical device commerce in Southeast Asia. Dec 16, 2024 · Stay updated on the Thai FDA's revised guidance for Software as a Medical Device (SaMD) and AI. Starting from 3rd December 2022, Thai FDA agreed to implement the new risk classification from Notified Medical Device (Class 2 or 3) to Listing Medical Mar 22, 2021 · The new announcement for the medical device regulation. Feb 25, 2021 · Medical Device Registration in ThailandPlease note on the possible changes below: Classification changes from General, Notification and Licensed to 1 listing 2&3 Notified and 4 Licensed Some previously licensed medical device like Condoms, gloves and contact lenses might be re-classified as Notified class The previous requirements for General Medical Device (Free Sale Cert and ISO 13485) would Streamline medical device registration in Thailand with expert support for classification, documentation, and Thai FDA submission processes. This four-tier system has been developed to ensure compatibility with the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD), thus simplifying trade. By removing the pre-submission Apr 27, 2022 · In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notifi Jan 15, 2025 · Stay informed on the latest Thai FDA change notification guidelines effective 15 January 2025. 2562 (2019), enacted by the King Rama 10th, by and with the advice and consent of National Legislative Assembly, is divided into 16 Sections as follows: 1. Mar 25, 2021 · The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and IVDs. Medical Device Control Division, Food and Drug Administration was officially established in June 1990 as regulatory authority to control manufacturing, importing, selling and advertising of medical devices in Thailand. Aug 26, 2021 · Thai FDA has announced the requirements for labeling of Licensed medical devices, Notified medical devices, and Listing registration numbers. WHO Prequalification of in Vitro Diagnostics (IVD) Compliance with Thailand Medical Device Regulations requires manufacturers to meet specific quality and clinical requirements, depending on the device classification. Medical Device Registration We can provide you excellent step-by-step professional service in compiling a submission dossier, known as the CSDT and submit on Thai Food and Drug Administration (Thai FDA) Medical Device Control Division, and follow up and liaise with the authorities to get your medical devices registered in Thailand. Aug 4, 2025 · Medical device regulations in Thailand divide products into four risk-based classes — from Class 1 (low risk) to Class 4 (high risk). Get expert guidance on medical device registration in Thailand. Thailand’s regulatory framework offers a structured, risk‑based approach to classification of non-IVD medical and IVD devices, closely following ASEAN directives and Thai‑specific rules. Jul 3, 2021 · In brief Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B. The expedited routes include the Concise Evaluation, the Reliance Program, and the WHO CRP for IVD routes, which have specific applicable conditions and May 6, 2020 · Medical Device Act (Issue 2) B. Nov 24, 2021 · Guideline for Renewal of Licensed and Notified Medical Device Licenses 1. This comes a little over a year after the TFDA implemented their new regulations and provided their initial estimated review times. Medical Device Regulation in Thailand 27th January 2021 Medical Device Control Division Thai Food and Drug Administration, Ministry of Public Health Determine the risk class of your medical device (Class 1, 2, 3, or 4) as per Thai FDA guidelines. Thailand’s dynamic healthcare market is full of opportunity, but its regulatory landscape can be challenging to navigate. Nov 1, 2024 · This article details the key aspects of market access in Thailand, including regulatory authorities, product classification, registration processes, and post - market supervision. Learn about classification, licensing, and compliance with Thailand’s FDA regulations. 2562 (2019) (Issue 2) Medical Device Act B. MEDICAL DEVICE REGISTRATION AND APPROVAL IN THAILAND Thai FDA has announced the official medical device guidance regarding the technical documents requirements after promptly complete a transition from policy-based classification to risk-based classification of medical devices. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification. Feb 24, 2021 · The Thai FDA has issued new regulations for medical device classification and registration part of which came into effect on 15th February 2021. To qualify for expedited evaluation routes, devices must be classified as Class 2, 3, or 4 according to Thai FDA risk classification. MEDICAL DEVICES RISK CLASSIFICATION IN THAI FDA 1. This classification aligns with ASEAN Medical Device Directive (AMDD) to ensure safety and performance, and to protect consumers and patients. This process will significantly reduce Class 1 approval times. Formerly most medical devices fell under the General Medical Device category and were subject to a simple listing process. If successful, the Regulatory Authority will issue the Licence for Sale. Sep 25, 2021 · Medical device definition in Thailand Products that make therapeutic, medical, or dental claims are considered medical devices in Thailand, including aesthetic devices and software as medical devices. Rigorous regulatory requirements are necessary to guarantee that medical devices are well-studied, safe, and well-tolerated in light of their growing use. Importer and Distributor: Local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA's manual of medical device classification. Aug 25, 2025 · From July 22, 2025, Thai FDA eases renewal for Class 2–4 medical devices. 2 For the first time in the history, a three-class, risk-based classification system was created for all medical devices and regulatory pathways were established for new medical devices. Jan 27, 2024 · Ministry of HealthMinistry of Health Ministry of Public Health – Thailand Food & Drug Administration (Thai FDA) Regulatory Authority Medical Devices Control Division (MDCD) Medical Device Regulation Medical Device Act/Ordinance B. In order to ensure that the control and regulation of medical devices are efficient and consistent with the control of medical devices at the ASEAN region and international levels, it is expedient to classify classes of medical devices or medical devices or medical devices according to the level of their risks of danger to the health, body or life of human or impacts on public health with a New medical device regulations by Thailand’s Food and Drug Administration (Thai FDA) in 2021 introduced a more structured and transparent medical device registration process. 2565, effective 03 December 2022, repealing The Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) B. Thai FDA would like to ensure that all medical device risk classifications follow a Dec 18, 2019 · Thai FDA clarifies 3 types of classification of non-in vitro medical device, Licensed medical device, Notified medical device, and General medical device regarding risk assessment. ) Step 3 : Establishment Licensing Anyone who wishes to manufacture or import medical devices for commercial purposes must register their establishment with the Thai Nov 13, 2023 · Thai FDA medical device registration The oversight of Thailand’s medical device regulations falls under the jurisdiction of the Medical Device Control Division (MDCD) within the Thai FDA. Introduction Section: In this section, Thailand government improves the registration regulatory by amended 2 definition terms; 1) Accessory: means goods, appliances or products that the manufacturer or the Specialist Reviews, while optional for Class 2, 3, and 4 medical device applications, are subject to selection by the Thai FDA at their discretion. Section 6 The provisions under (1) of section 6 of the Medical Device Act B. Learn about process of import license for medical devices in Thailand, licenses types, Thai FDA regulatory requirements to compliance. Compliance with Thailand Medical Device Regulations requires manufacturers to meet specific quality and clinical requirements, depending on the device classification. Whether you’re a new player or a global brand, we handle the regulatory The Thai FDA provides information on laws and regulations for health products and medical devices. 2551 and its amendments, which were adjusted according to the ASEAN Medical Device Directive (AMDD), there have been more updates on the medical device regulations under the Thai Food and Drug Administration (FDA). So briefly introduction of medical device. The manufacturers of Medical devices with a drug component need to register as a pharmaceutical. There have been changes in the medical device classification, registration pathways and process, timelines and fees. Learn timelines, documentation rules, and how local representation affects licensing and compliance. May 14, 2022 · The New Announcement on Medical Device Regulation issued in 2021 transited the THAI FDA Medical Device Classification from Policy-based to Risk-based. A Thailand medical device license is certainly obtainable and you can even open a business as a medical device importer if you so choose. The new medical device classification is risk-based instead of policy-based and makes the full process more accurate and strict. The New Announcement on Medical Device Regulation issued in 2021 transited the THAI FDA Medical Device Classification from Policy-based to Risk-based. This guideline has been published under the authority of the Thai Food and We would like to show you a description here but the site won’t allow us. The policy-based classification and regulation in Thai language set a barrier for foreign manufacturer to access Thai market Aug 11, 2023 · Device Classification and Requirements Before embarking on the journey of importing medical devices to Thailand, it’s essential to comprehend the classification categories established by the Thai Medical Device Act. With the country aligning its medical device regulatory system to the ASEAN Medical Device Directive (AMDD), manufacturers targeting Thailand must now adhere to stricter, harmonized requirements, starting with accurate device classification. This guide outlines the key steps, classifications, and requirements set by the Thai Food and Drug Administration (FDA) to help you understand and comply with local regulations. These updated announcements are Technical documents for Licensed medical device registration, Notified medical device registration and document preparation for Listing The costs associated with medical device registration will vary depending on the device you wish to import and what its classification is to the Thai FDA. E 2551 (2008) Official Language Thai Classification Class I, II, III and IV Registration Process There are two Thailand Medical Device Grouping The Thai FDA recently released new grouping guidance for medical devices. Medical Device Regulations and Classification in Thailand REGULATORY AUTHORITY: Medical Device Control Division (MDCD) of Thai Food and Drug Administration (TFDA) working under Ministry of Public Health. Thailand is experiencing a growing awareness of the importance of early disease detection and prevention, leading to increased demand for diagnostic tests. 2565, that has become effective on 03 December 2022. The Thai Food and Drug Administration has the authority to cancel the listing certificate under Section 70/1 (1) of the Medical Device Act, B. The Thai FDA categorizes IVD devices into seven distinct classes based on their intended use, risk level, and potential impact on public health. Registration requirements will differ depending on the devices’ risk classification as the table below. The Thai Food and Drug Administration (Thai FDA) regulates the registration of IVD devices to ensure safety, efficacy, and quality. In 1976, the Medical Device Amendments to the FD&C Act was implemented. License renewal and Notified Medical Device License which will expire on 31 December 2021, shall proceed License (s) renewal via the SKYNET system. Device Conformity Assessment (Thailand) Medical devices follow one of three approval routes depending on their classification: Class 1: Listing Class 2–3: Notification Class 4: License Under the current Rules, Conformity Assessment requires Class 2–4 submissions in the Common Submission Dossier Template (CSDT) Full format, while Class 1 (Listing) devices require limited documentation. Previously, there were no strict requirements for medical device labeling but this regulation stipulates the information that needs to be included for these products. 3 B. 2551 and its… Mar 16, 2022 · Formal Classification and Grouping Guidance Still Available by Separate Process Starting on March 15, 2022, the Thai FDA will remove the initial pre-submission step from the medical device registration process. This is the complete descritpion of Medical Devices risk classification in Thailand, issued and used by Thai FDA. May 14, 2022 · In the table below, we answer to your question about your THAI FDA Medical Device Classification. Classification of Medical Devices: Properly classify your medical device based on its intended use, potential risks, and other classification criteria outlined by the Thai FDA. Cisema supports medical device market entry in Thailand with regulatory expertise and services aligned with Thai FDA requirements. However, successfully accessing this market begins Understand Thailand’s medical device and IVD regulations, risk-based classification, registration pathways, and Thai FDA requirements. 3. Introduction If you’re planning to introduce your medical device to the Thai market, you’re tapping into one of Southeast Asia’s most promising healthcare economies. Understanding and confirming device classification and grouping eligibility early can streamline submissions and accelerate time to market. The Thai FDA published guidance to assist with the determination of medical device status and risk classification for SaMD in Thailand. Thai FDA categorized medical devices into 3 classes which are Licensed medical device, Notified medical device and Listing. ) Other equipment, products or articles prescribed by the Minister as medical devices by publication in the Government Gazette May 24, 2023 · The Thai FDA (Thailand Food and Drug Administration) has implemented expedited routes for medical device registrations to accelerate the approval process and provide faster access to innovative medical technologies for patients in Thailand. Sep 29, 2021 · Prior to the importation into Thailand, local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA’s manual of medical device classification. Find out more. Oct 15, 2021 · The Thai FDA published a revised fee schedule covering medical and diagnostic device registration applications and other review processes. Classification dictates the type of registration and the Sep 3, 2025 · The Thai FDA introduces new renewal system for Class 2–4 medical device licenses and notifications, with requirements based on adverse events. E. There are currently 531 Thailand’s medical device registration requirements follow different processes according to the product’s classification and whether it is a new registration or an already registered medical device in Thailand. Risk classification dictates the documentation and evaluation requirements. The Thai medical device market in the past years has been greatly supported by the advantages of its service quality and standard. An ANSWERED ON THIS PAGE: What is the medical device registration process in Thailand? How does Thailand classify medical devices and IVDs? Is an in-country representative required for foreign manufacturers? Thailand’s medical device regulations Medical devices and in vitro diagnostics (IVDs) are regulated by the Medical Device Control Division (MDCD) within the Thai Food and Drug Mar 25, 2021 · The Thai Food and Drug Administration (Thai FDA) has issued new rules on classification and registration of Medical Devices and IVDs. Most of the medical devices in Thailand is a Class III general medical device (lowest risk), including drug-eluting coronary stent and catheter system. Nov 29, 2023 · Entering a new international market comes with its own set of challenges and intricacies. We would like to show you a description here but the site won’t allow us. Asia Actual can help navigate the Thailand IVD Device Registration and approval process with top level consultants in Thailand to manage the application process. Contact us now! Thailand’s dynamic healthcare market is full of opportunity, but its regulatory landscape can be challenging to navigate. Jun 29, 2025 · Learn what qualifies as a family of medical device under Thai FDA rules, including accepted variants and grouping benefits for registration. We simplify medical device registration in Thailand, guiding you through every step to ensure compliance with Thai FDA regulations and a faster market entry. The process to register a medical device can take from 200 – 300 days to receive approval. Mar 19, 2022 · What's the criteria Thai FDA follows for group classification of medical devices in Thailand? device bundles can be grouped in 6 different Jan 9, 2024 · An establishment registrant who would like to register a medical device in Thailand must first classify the risk of the medical device. Class II devices must be notified to the Regulatory May 22, 2021 · Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. loq oom gbguxede jbqf hizaton pzvre outr pxfwh spvxd dezglnnhs odeh zhhaama aqtaiu pgqzq bkxt