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July 1, 2025
Approximately 5 minutes
The Thailand Food and Drug Administration (TFDA) is the national regulatory body and competent authority responsible for overseeing the registration, evaluation, and monitoring of various products, including food, drugs, and medical devices, to protect public health and consumer rights.
Medical device registration and regulation within the TFDA is specifically managed by the Medical Device Control Division (MDCD), established in 1991. The key responsibilities of the MDCD include:
Thailand's medical device regulatory process is primarily based on the Medical Device Act B.E. 2551 (2008), which was subsequently updated by the Medical Device Act/Ordinance B.E. 2562 (2019).
In an effort to modernize its framework and align with regional standards, the Thai government ratified the ASEAN Medical Device Directive (AMDD) in 2015. This alignment has led to several significant regulatory updates in recent years, including:
The MDCD has implemented measures to streamline the application process for new devices, largely relying on its e-Submission Interface. This electronic portal is central to the pre-market registration process for manufacturers and their local License Holders.
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ElendiLabs
Under the B.E. 2568 labeling notification effective in 2026, the post-importation labeling grace period has been reduced from 180 days to only 30 days (in some specific categories, 120 days—but the strict 30-day rule is becoming the default for high-risk devices).
yvonne
MDCD 对“本地代理人（AR）”与多个进口商关联的管理提问： 为了渠道灵活性，我们希望委任一家独立咨询公司作为我们的本地授权代表（AR）持有证书。MDCD 是否允许在同一个产品注册证下，由 AR 授权给 3 家不同的本地经销商作为“联合进口商”？在这种架构下，如果发生不良事件（AE），MDCD 追究法律责任的首要对象是谁？
ElendiLabs
MDCD 允许这种“一证多户”的操作。AR 作为注册证持有者（License Holder），可以向 MDCD 申请签发多份**进口授权书（Letter of Permission to Import）**给不同的经销商。然而，在法律责任上，AR 是 MDCD 的唯一首要联系人和法律责任主体。如果发生 AE，AR 必须在 48 小时（威胁公共安全）或 10-30 天（其他事件）内向 MDCD 报告。如果因经销商未及时上报导致 AR 延误报告，MDCD 依然会直接处罚 AR，甚至注销该企业的经营执照（Establishment License）。
Anonymous
我们有多款 2 类和 3 类器械的许可证将于 2026 年底到期。MDCD 目前推行的 Skynet 自动续展系统 是否适用于所有产品？如果我们在过去 5 年内发生过一次非严重性的“现场安全纠正措施（FSCA）”，我们是否仍能走“自动续展”通道，还是必须转入人工审查流程？
ElendiLabs
根据 MDCD 2025-2026 年的政策，只有符合“Case 1（无不良事件及纠正记录）”的 Full CSDT 产品才能实现真正意义上的“自动续展（Auto-approval）”。由于您有 FSCA 记录，系统会将其识别为“Case 2”，要求您上传详细的纠正措施报告及上市后监管数据。这种情况下，MDCD 官员会介入进行人工审查，您应在 10 月 1 日窗口开启时立即提交，以预留出应对补件要求（QA）的时间。
yelimeng
我们的三类骨科植入物已获得新加坡 HSA 的上市许可。如果我们选择走 MDCD 的 HSA-TFDA Reliance Route，MDCD 是否仍会对我们的 CSDT 技术文档进行完整的技术评审？在 2026 年的最新实操中，该路径能否豁免“专家评审（Expert Review）”环节及其产生的 53,000 泰铢额外费用？
ElendiLabs
MDCD 在互认路径下主要进行“一致性核查”而非重复性的完整技术评估。只要您提交给 TFDA 的技术参数、预期用途与 HSA 核准的版本完全一致，MDCD 通常会豁免专家评审环节，这不仅能节省 5.3 万泰铢的专家费，还能将评审周期从标准的 200-300 天缩短至 60-90 天。但需注意，MDCD 仍会严格检查泰语标签是否符合 2026 年生效的 B.E. 2568 新规。
Approximately 5 minutes
Thailand's regulatory process, overseen by the Thai FDA's MDCD, follows the Medical Device Act B.E. 2562 (2019) and aligns closely with the ASEAN Medical Device Directive (AMDD). Devices are classified into four risk categories (1-4) and require one of three approval routes: Listing, Notification, or License.
Approximately 5 minutes
Medical devices in Thailand are classified into four risk categories (Class 1-4) based on intended use, invasiveness, and risk, closely following ASEAN MDD rules. Manufacturers can formally confirm their device classification by submitting an online application to the Thai FDA.
Approximately 5 minutes
Thailand's new grouping guidance simplifies the registration process, allowing multiple products to be included in a single submission. Devices must share a product owner, intended purpose, and proprietary name, and can be grouped as a Single device, Family, System, Set, IVD Test Kit, or IVD Cluster, subject to specific variant rules.
Approximately 5 minutes
The Thai FDA requires device defects and Adverse Events (AEs) occurring globally to be reported if the product is on the Thai market, following AMDD Annex 5 guidelines. The local Registration Holder is responsible for submitting reports and maintaining distribution/complaint records for at least five years.
Approximately 5 minutes
Thailand's labeling rules, detailed in Ministry of Public Health Notification 137, require all home-use devices to be labeled in Thai. Devices used only by physicians can use Thai or English. The importer can affix the required labeling, including essential product and manufacturer details, within 180 days of the device entering the country.
Approximately 5 minutes
The Thai FDA regulates medical device advertising based on the target audience. Direct-to-Consumer (DTC) ads require prior approval, while advertisements targeted solely at Healthcare Professionals (HCPs) are generally exempt, provided they are not visible to the public. Approval licenses are valid for up to 3 years.
Anonymous
We understand that the TFDA has significantly shortened the grace period for affixing Thai labels after the goods have passed through Customs. As a foreign manufacturer, if our Class 2 cardiovascular catheters arrive at a Bangkok warehouse, how many days do we have to complete the Thai labeling before the MDCD considers it a compliance violation?