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Medical-Devices-Registration-in-Thailand

Medical Devices Registration in Thailand

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  2. Medical Devices Registration in Thailand

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    Overview of Thailand’s Medical Device Market

    Thailand’s medical device market is a rapidly growing sector, valued at approximately USD 2.3 billion in 2024 and projected to expand at a CAGR of 6–7% through 2029. The market is driven by an aging population, rising chronic diseases, and the country’s position as a leading medical tourism hub. Imports dominate the high-tech device segment, while exports focus on disposables like gloves and syringes. Government initiatives such as Thailand 4.0 and support from the Board of Investment (BOI) are encouraging local production and innovation. Regulatory alignment with ASEAN standards further supports market growth and international competitiveness.

    Thailand Medical Device Classification System

    Thailand’s medical device classification system, regulated by the Thai FDA under the Medical Device Act B.E. 2551 and aligned with the ASEAN Medical Device Directive (AMDD), categorizes devices into four risk-based classes. Class 1 (lowest risk) includes non-invasive tools, Class 2 covers low-to-moderate risk devices, Class 3 involves moderate-to-high risk devices, and Class 4 includes high-risk or life-sustaining products. Classification is based on intended use, invasiveness, duration of contact, and risk level. Each class requires varying documentation and review procedures, with higher classes undergoing more stringent pre-market assessments. This system ensures safety, efficacy, and regulatory clarity for market access.

    Thailand FDA Medical Device Registration Process

    • Classification: Devices are categorized into Class 1 (lowest risk) to Class 4 (highest risk) based on ASEAN AMDD.
    • Local Representative: Foreign manufacturers must appoint a Thai Authorized Representative.
    • Pre-Submission: Prepare documentation, including technical files, labeling, and quality certificates.
    • e-Submission: Submit application via Thai FDA’s online system.
    • Review Process:

      • – Class 1: Notification with minimal review.

      – Class 2–4: License application with detailed evaluation.

    • Approval Timeline: Varies by class (weeks to several months).
    • License Validity:

      • – Class 1: 5 years

      – Class 2–4: 4 years

      Government Authority

      In Thailand, the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA) oversees the medical device registration process. This regulatory framework is guided by the Medical Device Act B.E. 2551 (2008) and further updated by the Medical Device Act/ Ordinance B.E. 2562 (2019) (Issue 2). Recent regulatory revisions, effective February 15, 2021, align more closely with the ASEAN Medical Device Directive (AMDD).

      Thailand’s medical device registration process requires adherence to stringent standards set forth by the MDCD. Manufacturers seeking market approval must meticulously prepare documentation and ensure compliance with regulatory requirements. The MDCD conducts thorough evaluations to assess the safety, quality, and efficacy of medical devices before granting registration.

      Upon successful completion of the registration process, manufacturers receive approval from the MDCD to market and distribute their medical devices in Thailand. It is essential for companies exporting products to Thailand to understand and comply with these regulations to facilitate seamless entry into the Thai market.

      Continuous monitoring and compliance with post-registration requirements are imperative to maintain market authorization and ensure the ongoing safety and efficacy of medical devices in Thailand. By navigating the medical device registration process in Thailand effectively, manufacturers can access a thriving market and contribute to improving healthcare standards in the region.

      Product Categorization

      In Thailand, medical devices are categorized into four classes (1 through 4) based on the level of risk, closely aligned with ASEAN MDD guidance. While Annex 2 of the ASEAN MDD provides general classification criteria, additional Thai-specific rules are available. Below are key guidance documents outlining classification criteria for each category:

      Guidance Document Name Purpose Link
      Ministerial approval needed for listing medical devices. Defines criteria for Class 1, Listing. Thai
      Ministerial Regulations mandate Notification Approval for Medical Devices. Specifies criteria for Class 2 or 3, Notification category. Thai
      Ministerial Regulations mandate License Approval for Medical Device Products. Defines criteria for Class 4, Licensing category. Thai

      These guidance documents provide essential information for companies seeking medical devices registration in Thailand, ensuring compliance with local regulatory standards.

    Medical-Devices-Registration

    Medical Device Registration Requirements

    Requirements for registering medical devices in Thailand entail various documentation submissions, all to be prepared in English. Essential documents include a detailed device description, pre-clinical study data, labeling, usage instructions, risk analysis, and evidence of compliance with ISO 13485 standards.

    It’s worth noting that specific medical devices may necessitate additional permits from the Thai FDA or other government bodies. This is especially true for devices involving radiation or wireless connectivity. Additionally, certain products may require testing in accredited Thai laboratories to ensure compliance with local regulations.

    Ensuring compliance with Thailand’s medical device registration process is vital for companies seeking market access in the country. By meticulously preparing and submitting the required documentation, manufacturers can navigate the registration process smoothly and efficiently.

    Registration Fees

    Risk Classification Class 1 Class 2 / Class 3 Class 4
    Registration type Listing Notification Licensing
    Submission Fee 500 Baht
    (US$ 17)    		 1,000 Baht
    (US$ 33)    		 1,000 Baht
    (US$33)
    Specialist Review Fee (Novel Devices) N/A 38,000 Baht
    (US$ 1,267)    		 53,000 Baht
    (US$ 1,767)
    Approval Fee 2,600 Baht
    (US$ 87)    		 10,000 Baht
    (US$ 333)    		 20,000 Baht
    (US$ 667)
    Total Fee (with Specialist Review) 3,100 Baht
    (US$ 104)    		 49,000 Baht
    (US$ 1,633)    		 74,000 Baht
    (US$ 2,539)
    Max Review Time 1 – 8 days 250 days 300 days

    Each medical device registration in Thailand incurs a fee, which is classified as non-tax. The following outlines the updated fees effective March 2021, along with the corresponding turnaround times for e-submissions.

    Validity and Timeline

    Following approval, all types of Registration Licenses remain valid for a duration of 5 years in Thailand. Renewal procedures are available for Class 1 Listings, offering a more cost-effective option compared to the initial registration applications. However, for Class 2-4 listings, renewal fees are currently aligned with those of initial registrations, with the potential for changes in the future. Products registered under previous regulations are granted one renewal opportunity through a partial application before necessitating a full registration upon expiration of the renewed license, five years later. Specific documentation requirements for partial applications are contingent upon the renewal date.

    Trust Maven for your medical devices registration needs in Thailand. Our comprehensive services ensure a smooth and efficient registration process, allowing your products to enter the Thai market seamlessly. With our expertise, you can navigate the complexities of medical device registration in Thailand with confidence. Let Maven be your partner in achieving compliance and success in the Thai market.

    FAQ:

    In Thailand, a medical device license is typically valid for five years from the date of approval, regardless of its risk classification. This applies to all three registration types: Listing (Class 1), Notification (Class 2 and 3), and Licensing (Class 4), as defined by the Thailand medical device classification system. After this period, manufacturers must submit a renewal application to maintain market authorization.

    For Class 1 devices, renewal is relatively straightforward and cost-effective. However, Class 2 to Class 4 devices must go through a more detailed renewal process, often requiring the same level of documentation as the initial application. Products approved under older regulations are allowed one partial renewal before needing full re-registration.

    It’s essential for companies to stay compliant with Thailand medical device regulations and plan timely renewals to avoid disruptions in market presence. At Maven, we assist clients with medical device registration in Thailand, ensuring smooth transitions during renewals and updates in accordance with Thailand FDA (TFDA) medical device guidelines. Our Thailand FDA (TFDA) licence consulting services help manufacturers confidently manage their product lifecycle in the Thai market.

    In Thailand, medical device regulation is governed by the Thai FDA’s Medical Device Control Division (MDCD), under the Ministry of Public Health. The primary regulatory framework is based on the Medical Device Act B.E. 2551 (2008), updated by Act B.E. 2562 (2019), aligning closely with the ASEAN Medical Device Directive (AMDD). All manufacturers must obtain approval from the Thai FDA before marketing their products.

    Thailand medical device registration is risk-based, dividing products into four classes. Each class follows specific regulatory pathways—Listing, Notification, or Licensing—depending on the risk level. The process requires detailed documentation, including ISO 13485 certification, product labeling, safety data, and sometimes local testing.

    For successful medical device registration in Thailand, manufacturers must meet strict criteria and submit electronic applications. Upon approval, a license valid for 5 years is issued. It’s important to stay updated with Thailand medical device regulations to maintain compliance.

    At Maven, we specialize in Thai FDA (TFDA) medical device approvals and Thai FDA (TFDA) licence consulting, ensuring your registration journey is smooth and compliant.

    The registration process for medical devices in Thailand varies based on the device’s risk classification. For Class 1 (Listing) devices, approval may take just 1 to 8 days, making it the fastest route. However, for Class 2 and 3 (Notification) devices, the process can take up to 250 days, while Class 4 (Licensing) devices may require as long as 300 days due to more extensive evaluations and specialist reviews. These timelines apply to e-submissions made through the Thai FDA system.

    Understanding the timeline is crucial for planning your product launch in Thailand. At Maven, we support manufacturers with end-to-end guidance on Thailand medical device registration, ensuring timely and accurate submissions. Whether you’re seeking a Thai FDA (TFDA) medical device license or navigating Thailand medical device regulations, our consultants help reduce delays and ensure compliance. For efficient medical device registration in Thailand, trust our proven expertise.

    In Thailand, medical device registration is governed by the Thai FDA under the Ministry of Public Health. Based on the Thailand medical device classification, devices are categorized into four risk-based classes: Class 1 (Listing), Class 2 and 3 (Notification), and Class 4 (Licensing). Each category requires a specific type of registration license depending on the device’s risk level.

    For higher-risk products, such as Class 4 devices, a Licensing approval is mandatory, while lower-risk devices may only need a Listing or Notification. The registration process involves submitting technical documentation, proof of ISO 13485 compliance, labeling, and in some cases, specialist reviews. The Thai FDA then issues a Thailand FDA medical device license, valid for five years.

    To ensure full compliance with Thailand medical device regulations, manufacturers often partner with Thai FDA licence consulting experts. This helps streamline the process and reduce approval times. Whether you’re listing or licensing, understanding the requirements for medical device registration in Thailand is essential for market access.

    The medical device market in Thailand is rapidly expanding, driven by increased healthcare demand, aging population, and a growing focus on advanced technologies. As one of Southeast Asia’s most dynamic economies, Thailand’s healthcare sector continues to invest in modernizing its infrastructure, leading to a significant rise in medical device imports and manufacturing. In fact, the market is projected to surpass USD 2 billion in the coming years, making it a strategic destination for global medical device companies.

    To enter this market, manufacturers must follow strict Thailand medical device registration protocols set by the Thai FDA. Understanding Thailand medical device regulations, classification rules, and the overall medical device registration in Thailand process is crucial for successful product entry. Additionally, seeking professional Thailand FDA licence consulting can streamline approval timelines. As the country aligns more with international standards and the ASEAN Medical Device Directive (AMDD), Thailand is becoming an increasingly attractive market for innovative medical technologies.

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