Taiwan is a significant player in the global medical device market, with robust regulations ensuring safety, efficacy, and quality. Navigating the regulatory landscape is crucial for manufacturers aiming to enter or expand in this market. This blog provides a comprehensive overview of the key aspects of medical device regulation in Taiwan.
Health Authority Regulating Medical Devices in Taiwan
The Taiwan Food and Drug Administration (TFDA), part of the Ministry of Health and Welfare (MOHW), is the primary regulatory authority overseeing medical devices in Taiwan. The TFDA is responsible for implementing regulations, reviewing applications, and ensuring compliance with safety standards.
Taiwan FDA (TFDA) Regulation of Medical Devices in Taiwan
Medical device regulation in Taiwan is governed by several key pieces of legislation:
Medical Devices Act - This act establishes the foundational legal requirements for the approval, registration, and oversight of medical devices.
Enforcement Rules of Medical Devices Act - The Enforcement Rules of Medical Devices Act complement the Medical Devices Act by providing detailed regulations and procedures for its implementation.
Taiwan FDA Classification of Medical Devices and IVDs in Taiwan
Medical devices in Taiwan are classified into four categories based on risk:
Class I: Low-risk devices with minimal potential for harm.
Class II: Moderate-risk devices with a higher level of risk than Class I.
Class III: High-risk devices that require extensive review due to potential risks.
Class III: New Devices with no approved predicate device in Taiwan
Local Representative Requirements for Medical Devices in Taiwan
In Taiwan, foreign manufacturers must appoint a local representative referred as Taiwan Agent to handle registration, regulatory compliance, and communication with the TFDA. This representative must be a registered entity with legal standing in Taiwan. Foreign manufacturers are required to issue a Power of Attorney to a designated Taiwan Agent. This legal document authorizes the Taiwan Agent to act on behalf of the manufacturer in all regulatory matters related to the medical device.
The Taiwan Agent plays a crucial role in the regulatory framework and is responsible for several key functions:
Local Labeling shall include the Agent’s details.
Post-Market Vigilance - reporting any adverse events or safety concerns to the relevant authorities.
Traceability of devices available on the market
Retention of Device History Documents
While the Taiwan Agent handles regulatory and compliance responsibilities, the License Holder (the manufacturer) is not required to be directly involved in the importation of products. Instead, the License Holder must authorize qualified Distributors to manage the importation and distribution of the medical devices within Taiwan.
TFDA Medical Device Registration Pathways in Taiwan
In Taiwan, the process for registering medical devices varies based on the device’s classification and type. Here’s an overview of the registration pathways:
Class I Medical Devices are subject to an Administrative Review. This review focuses on ensuring that the submitted documentation meets regulatory requirements and does not involve a detailed technical evaluation.
For Class II and III Medical Devices, the registration process involves two stages of review: Administrative Review to ensure all required documentation is submitted and Technical Review involving a detailed technical evaluation of the device’s safety, efficacy, and performance
New Medical Devices also undergo both stages of review like the Class II and Class III Medical Devices
TFDA In Vitro Diagnostic Devices (IVDs) Registration Pathways in Taiwan
Similar to medical devices, the process for registering IVDs also vary based on the IVD rick class.
Class I and II IVDs: These categories of IVDs do not require registration. They are subject to less stringent regulatory requirements compared to higher-risk devices.
Class III and New IVDs: These IVDs must undergo the two-stage review process, which includes both Administrative and Technical Reviews.
Taiwan FDA GMP Requirements for Medical Devices in Taiwan
Before manufacturers can market their Class I measuring/sterile, Class II, or Class III medical devices in Taiwan, they must comply with Taiwan's Good Manufacturing Practices (GMP). QSD is not required for Class I non-measuring, non-sterile products. The process to obtain QSD approval can take up to 10 months. Alternatively the manufacturers can leverage ISO 13485 Certification to satisfy some GMP requirements, provided it was issued by one of the six TCP III approved Notified Bodies. TCP III represents the third version of the TFDA-EU Technical Cooperation Program (TCP).
Taiwan FDA Labeling Requirements for Medical Devices in Taiwan
In Taiwan, medical device labeling must adhere to specific requirements to ensure compliance and safety. Here’s a summary of the key labeling requirements:
Mandatory Labeling Information : Labels, instructions, or packaging must clearly include the following details:
Product Name: The name of the medical device.
License or Listing Number: Identifies the product's registration status.
Effectiveness and Intended Use: Describes what the device is used for.
Date of Manufacture and Shelf-Life: Indicates the production date and expiration date.
Model Number and Specifications: Provides detailed product information.
Warnings and Cautions: Includes safety warnings, limitations, and potential side effects.
License Holder Information: Name and address of the entity responsible for the product listing.
Manufacturer Information: Name and address of the manufacturer.
Lot or Serial Number: For traceability.
Additional Details: As specified by the central competent authority.
Smallest Package Labels: Must include essential details and be affixed to the device, packaging, or instructions.
Chinese Labels and Instructions: Must be in Chinese and include critical product details. If multiple models use the same label, a representative label is allowed. For large outer boxes, a photo of the label can substitute. Specific products, such as condoms or in vitro diagnostic reagents, require both manufacture and expiration dates on the Chinese label. The font size for Chinese text must be at least 7 points, and foreign language text should be smaller.Chinese instructions should be based on translations of the original manufacturer's documents, including catalogs and manuals. Only critical information like indications and warnings needs to be translated.
Taiwan FDA UDI Labeling Requirements for Medical Devices in Taiwan
Manufacturers must collaborate with their license holders to ensure that UDI and corresponding product information are accurately uploaded to the Taiwan UDI Database (TUDID). This step is crucial for meeting regulatory standards and maintaining device traceability.
Documentation Requirements for Medical Devices in Taiwan
To apply for medical device registration in Taiwan, the following documentation is required:
Application Form: Complete and submit the official application form as part of the registration process.
Chinese Labeling and Instructions: Provide copies of Chinese labeling, instructions for use, and packaging inserts to ensure compliance with local language requirements.
Pharmaceutical License: Include a copy of the Pharmaceutical License for the Medical Device Manufacturer, Distributor, or Agent.
Truth and Accuracy Statement: Submit a statement affirming the truthfulness and accuracy of the information provided.
Free Sale Certificate: For imported products, include a Free Sale Certificate issued by the health authority in the country of origin, along with an authorization letter from the manufacturer.
Test Reports and Quality Control: Provide copies of preclinical test reports, quality control procedures, and relevant test reports to demonstrate product safety and efficacy.
Product Details: Include copies of product structure, materials, specifications, intended use, and technical drawings.
GMP/QSD Compliance Letter: Submit a copy of the GMP/QSD Compliance Letter to confirm adherence to Good Manufacturing Practices.
Literature Review: For Class III IVDs and new products, include a literature review to support the product’s efficacy and safety.
Clinical Investigation Reports: For Class III IVDs and new products, provide clinical investigation reports as part of the evidence of product safety and effectiveness.
Radioactive Safety Information: If applicable, include information regarding the radioactive safety of the product.
Clinical data is required only for Class III IVDs and new products. Class II medical devices with existing approvals from the US or EU may use previously available documentation in place of new preclinical test reports, quality control procedures, and test reports.
Pre-requisites for Medical Device Registration in Taiwan: Medical Device Business Permit
To register a medical device or in-vitro diagnostic device in Taiwan, the following permits are required:
Medical Device Business Permit: A copy of this permit must be provided. It demonstrates that the business is authorized to handle medical devices.
Manufacturers: If you are a manufacturer, you need to attach a copy of your medical device manufacturing permit.
Importers: If you are importing medical devices, include a copy of your medical device dealer permit, which should indicate that it covers "medical device import."
Contract Manufacturing: For domestic contract manufacturing, both the contract party's and the contract manufacturer's medical device business permits must be submitted.
Format: The medical device business permit must be submitted in A4 format.
Permit Application: Companies without the necessary permit must apply for it at the local health bureau.
Taiwan FDA (TFDA) Online Registration Requirements for Medical Devices in Taiwan
On January 21, 2022, the Taiwan Food and Drug Administration (TFDA) introduced the TFDA Medical Device Premarket E-Submission System, an online platform designed to streamline the pre-market application process for medical devices and reduce reliance on paper documents. This system provides manufacturers with an alternative method for submitting pre-market applications, enhancing convenience and aligning with the trend towards digitalization. While the TFDA encourages the use of this system for Class II and III medical devices, it is not mandatory. The E-Submission System, developed following the implementation of the Medical Devices Act on May 1, 2021, allows for the registration, alteration, and license extension of Class II and III medical devices. For further details, manufacturers and dealers can access resources, including implementation instructions, user manuals, and FAQs, on the TFDA's official website.
Validity of Medical Device Approvals in Taiwan
Medical device approvals are generally valid for five years. Manufacturers must apply for renewal before the expiration of their approval to maintain market access.
Advertising Permit Requirements for Medical Devices in Taiwan
Before publishing any advertising materials for medical devices in Taiwan, foreign manufacturers must coordinate with their local license holder to obtain the necessary permits from the Taiwan Food and Drug Administration (TFDA). The application process involves submitting several key documents, including the advertising materials themselves, the Medical Device Product License (MDPL), the approved Chinese Instructions for Use (IFU), and the Medical Device Applicant’s License. These requirements ensure that all promotional content complies with regulatory standards and provides accurate information to consumers.
PMS Requirements for Medical Devices in Taiwan
Post-Market Surveillance (PMS) is mandatory to monitor the ongoing safety and effectiveness of medical devices. Manufacturers must report any adverse events or product issues to the TFDA and take corrective actions as required.
License Transfer for Medical Devices in Taiwan
In Taiwan, medical device licenses are transferable, and the process must be completed jointly by both the transferor and the transferee. To apply for the transfer of a medical device permit license, the following documents are required:
Application Form: A completed application form for the change in the medical device permit license.
Medical Device Permit License: The original copy of the current medical device permit license.
Permit Letter of Assignment: The original copy of the permit letter from the pharmaceutical firm transferring the agency rights (assignor).
Affidavit from Assignee: An affidavit from the pharmaceutical firm receiving the agency rights (assignee), confirming their responsibility for the transferred device.
Authorization Certificate: The original copy of the foreign manufacturer’s authorization certificate. This certificate should detail the termination of rights for the transferor, the bestowal of rights to the transferee, include the product name, and state the names and addresses of both the assignor and assignee. The certificate must be valid for one year from the date of issuance by the original manufacturer.
Affidavit (A): Additional affidavit as required.
Assignee’s License: A photocopy of the pharmaceutical firm license for the assignee.
Renewal for Medical Device approvals in Taiwan
To renew their registration, manufacturers must submit updated documentation, including evidence of continued compliance with GMP and other regulatory standards. The renewal application should be filed before the existing approval expires.
Understanding and adhering to the regulatory framework for medical devices in Taiwan is essential for successful market entry and product commercialization. By following the guidelines and requirements outlined above, manufacturers can ensure compliance and streamline the registration process.
For detailed guidance on medical device regulations in Taiwan or assistance with the registration process, contact Artixio today at info@artixio.com. Stay informed and ensure your products meet all regulatory requirements for a smooth entry into the Taiwanese market!
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