Taiwan is a growing market for medical devices, but gaining entry requires strict adherence to Taiwan medical device regulations set forth by the Taiwan Food and Drug Administration (TFDA). Medical device companies looking to commercialize their products in this region must go through a meticulous registration process. In this blog post, we'll walk you through the key aspects of medical device regulatory requirements in Taiwan and highlight the importance of selecting an independent Taiwan Agent like Artixio to guide you through the process.
Medical Device Classification in Taiwan
Properly classifying your medical device as per Taiwan medical device regulations is the first step towards medical device registration in Taiwan. The TFDA classifies devices as Class I, II, or III based on their level of risk. It's crucial to have home country approval for Class II and III devices before seeking Taiwanese registration.
In Case of any uncertainty around the classification of medical device, the manufacturer can inquire about the classification of medical device with the central competent authority, with applications covering more than one product made separately. The TFDA application fee for this is 3500 NTD per application. Required documents include an inquiry about the classification of the medical device, manufacturer's instructions, classification reference information, and any other requested documents.
Medical Device Business Permit
A copy of the medical device business permit is a mandatory pre-requisite for medical device registration in Taiwan. Manufacturers must attach a copy of the medical device manufacturing permit, while importers must provide a copy of the medical device dealer permit that includes "medical device import" in the business category. Both the contract party and the contract manufacturer's medical device business permits must be submitted for domestic contract manufacturing.
Medical Devices Quality Management System (QMS) Requirements in Taiwan
QMS requirements are an essential part of the device registration process in Taiwan. While manufacturers in the US and Japan have alternatives to on-site audits for their Quality System Documentation (QSD) applications, companies outside these countries must undergo an on-site audit by the TFDA or provide an ISO 13485 certificate. US companies can submit a Certificate to Foreign Government (CFG) issued by the US FDA, while Japanese manufacturers can submit their Japanese Quality Management System audit report and certification from the Japan Pharmaceuticals and Medical Devices Agency or Registered Certification Body.
On-Site Inspection for Foreign Manufacturers
Foreign manufacturers importing specific medical devices to Taiwan may need to undergo an on-site inspection by the TFDA. The decision for these inspections is based on the risks associated with the device and its usage. The validity of the foreign manufacturing license is three years, with renewal applications accepted between 6 and 12 months before expiration.
Labeling and Instruction Compliance according to Taiwan Medical Device Regulations
Medical device manufacturers and importers aiming to enter Taiwan's market must meticulously adhere to the "Medical Devices Act," which mandates labeling and instruction requirements. Labels in Chinese, affixed to the smallest packaging unit for sale, and Chinese instructions are mandatory, unless exempted by the central competent authority. The labels, instructions, and packaging must feature critical details, including product name, license number, effectiveness, manufacturing date, and more. Chinese labels should also include the product's importer and manufacturing details, with specific product types requiring the inclusion of shelf-life or expiration dates. Chinese instructions must be predominantly in Chinese and cover product descriptions, indications, warnings, and other key information, while following specific font size and formatting guidelines. Importantly, translations of the original manufacturer's instructions must be provided for imported products, highlighting essential information. Adhering to these guidelines is essential for regulatory compliance and market success in Taiwan's burgeoning medical device sector.
TFDA Medical Device Registration process in Taiwan
The medical device registration process in Taiwan involves several steps:
Identify the classification of your device using the TFDA's database.
Nominate a Taiwan Agent.
Assemble a Quality System Documentation (QSD) application, unless your device is exempt, and pay the required fee.
Present the QSD application for TFDA review, after which they issue the QSD certificate.
Compile a registration dossier and submit it to the TFDA, along with the application fee.
The TFDA will scrutinize the application and may request supplementary information.
Once the TFDA grants approval, you will be issued a registration license.
The Role of Your Taiwan Agent
One of the first steps in the medical device registration process in Taiwan is the appointment of a Taiwan Agent. Your Taiwan Agent must be a legal entity in Taiwan with a Business License and a Medical Device Business Permit. The TFDA mandates that medical device and IVD manufacturers with no office in Taiwan must have an in-country regulatory representative. This representative's name and address must be included on the product label, alongside the registration number. The distributor may also add their information with a sticker. Here's what your Taiwan Agent can assist you with Quality System Documentation (QSD) Certification for Class II and III devices, and some Class I medical devices, device registration and act as a regulatory liaison between you and the TFDA.
Once your product is approved by the TFDA, your Taiwan Agent will hold your medical device registration, known in Taiwan as a Registration License. They are also responsible for filing Import Authorization requests to the TFDA for each distributor. This is why selecting an independent regulatory representative is often recommended over a distributor, as it ensures a smoother process.
In conclusion, the process of medical device registration in Taiwan is intricate and highly regulated. Navigating these requirements can be challenging, especially for companies without a local presence. Choosing an independent Taiwan Agent like Artixio can significantly ease the burden and ensure a smooth and efficient registration process. With their expertise and resources, they can help you through each step of the process, from document submission to quality system compliance and ongoing regulatory support. Keep in mind that staying up to date on TFDA regulations is crucial, as any changes could impact your devices and their registration status.
Make the right choice for your medical device company and secure a successful entry into the Taiwanese market with the guidance of a trusted partner like Artixio.