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When it comes to registering medical devices in Taiwan, one critical component is obtaining a Quality System Documentation (QSD). QSD serves as a paper-based evaluation and acts as a substitute for onsite audits. The Taiwan Food and Drug Administration (TFDA) issues QMS certificates for domestic manufacturing sites, while QSD certificates are issued for overseas manufacturing sites.
What is QSD and Why is it Important? QSD stands for Quality System Documentation, which is a necessary step for most medical device licenses. According to Taiwan’s Medical Device Management Act, Article 22, medical device manufacturers must establish and maintain a quality management system that encompasses facilities, equipment, personnel, production, quality control, storage, distribution, customer complaints, and other regulatory matters. The system must meet established guidelines, and once compliance is confirmed, manufacturers can apply for a production permit. Manufacturers based outside of Taiwan are required to submit a QSD as part of the registration process. QSD is a Prerequisites for Most Medical Device Registration Except for some low-risk, non-sterile medical devices, QSD is a mandatory requirement for obtaining a medical device license in Taiwan. While QSD and license applications can be submitted simultaneously, approval for QSD is required before the TFDA can grant the license approval. For a list of medical devices that do not require QSD, please refer to the TFDA’s guidelines here: TFDA QSD Exemption List. QSD Reviewing Process QSD certificates are valid for three years, and the renewal process mirrors the initial application process in terms of cost and duration. Typically, QSD renewal takes about 6-9 months to process. It is crucial to initiate the renewal process six months to one year before the expiration date to ensure there’s no disruption in your certification status. If the renewal is approved before the expiry date, the new expiry date will be three years from the original expiry date. Since QSD is designed to replace on-site audits, renewing a QSD is essentially treated as applying for a new QSD. You should anticipate the same time, cost, and effort for the renewal process. If your manufacturing site moves or if you need additional scopes covered, the amount of time and work is similar to those needed to register a new QSD. We recommend registering all the scopes you might need in the next three years. Types of QSD There are three types of QSD, each with its own set of requirements:
More information can be found at Required Documents for QSD. Scope and Manufacturing Site Specificity QSD is manufacturing site-specific and scope-specific. The QSD approval will list the approved activities for each manufacturing site. These activities may include:
Parallel Review Benefit and Risk QSD approval is a prerequisite for most medical device licenses in Taiwan. The TFDA allows parallel review of QSD and license applications. However, QSD approval must be obtained before the license can be granted. Both QSD and license applications are allowed one chance for deficiency response and one chance for appeal. Therefore, if QSD fails in the later stages, the risk of the license application being rejected is high. It’s crucial to address any deficiencies early in the process. Using Another Company’s QSD If a company in Taiwan already holds a valid QSD that meets all your needs (the same manufacturing site, scope, and activities), you can use their QSD for license registration. However, both the QSD holder and the manufacturing site must authorize this. The authorization can be revoked at any time by either party. QSD: A Time-Consuming Process QSD certification is a detailed and time-consuming process. Given its importance, we recommend planning ahead and allocating sufficient time and resources for the QSD application or renewal process. At Wonderville, we understand the complexities of obtaining QSD approval, and we are here to help guide you through every step. Contact us today for a free quotation on your QSD needs. Conclusion QSD is a vital component of the medical device registration process in Taiwan. Whether you are applying for a new QSD or renewing an existing one, it is essential to understand the requirements and timelines involved. Remember, QSD approval is necessary before a medical device license can be granted, so staying ahead of the renewal process is key to ensuring compliance. For more information or to begin the QSD process, reach out to Wonderville. We’re here to help you navigate this essential regulatory step with confidence.
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We get asked two questions all the time when it comes to medical device registration in Taiwan: Can I register my device as an individual? and Can I use my existing company (from another country) to register the device? Unfortunately, the answer to both is no. To legally register and import a medical device in Taiwan, you’ll need to go through a locally registered entity.
Local Company Requirement for Registration To put it simply: you must have a local company registered in Taiwan to register a medical device. Even if your company is already established abroad, it won’t be enough to register your device under that company’s name. Taiwan’s regulations require that the registration process is handled by a company that's set up in the country. Medical Device Business Permit and Import Technician Once your local company is established, the next step is obtaining a Medical Device Business Permit. In order to get this permit, your company must have a registered Import Technician. This person ensures that the devices you're importing comply with Taiwan’s regulations. Here’s a helpful note: the Import Technician doesn’t have to be an outside hire. It could even be the company owner or another member of your team, as long as they meet the necessary qualifications for the role. Assistance in Company Setup and Licensing While Wonderville doesn’t directly assist with setting up companies, we can refer you to a trusted local accountant we’ve worked with for years. They specialize in helping international companies get established in Taiwan, ensuring that all the regulatory requirements are met. From company registration to securing your medical device business permit, we can point you in the right direction for the help you need. Responsibility of the License Holder Now, it’s important to note that the holder of the medical device business permit has a significant responsibility. This includes ensuring the device complies with regulations throughout its lifecycle, as well as managing post-market activities like recalls. This is different from the role of a representative in other countries, where the representative may not have the same level of responsibility for the device’s compliance after it hits the market. Wonderville as License Holder At Wonderville, we’re ready to act as a license holder for select clients. However, we are very selective about who we work with. We only accept clients who adhere to the highest standards of legal compliance and ethical business practices. Our commitment to regulatory integrity is key, and we ensure that all involved parties meet Taiwan’s legal requirements. Conclusion To sum it all up, if you’re planning to register a medical device in Taiwan, you’ll need to establish a local company, obtain a Medical Device Business Permit, and ensure that an Import Technician is part of your team. While Wonderville doesn’t handle company formation directly, we can refer you to a reliable local accountant to guide you through that process. We can also help you with securing the necessary permits and even act as a license holder for qualified distributors. However, we are discerning in our selection and work only with those who are fully compliant with Taiwanese laws. If you’re ready to start the process or have any questions, don’t hesitate to get in touch. We’re here to help you navigate this journey with ease and ensure full compliance. |