,Taiwan Quality Management System (QMS) Overview
The Taiwan Food and Drug Administration (TFDA) mandates that medical device manufacturers establish a Quality Management System (QMS) that covers various aspects such as facilities, equipment, organization and personnel, production, quality control, storage, distribution, customer complaints, and other relevant matters.
Manufacturers must comply with the QMS standards and submit their Quality System Documents (QSD) for review by the TFDA to obtain manufacturing permission. The QSD application process involves submitting an application form along with relevant documents, such as the manufacturer's license, product specifications, and evidence of compliance with international standards like ISO 13485.
The TFDA provides an online platform for the submission and management of QSD applications.
For foreign manufacturers, the QSD application process may also involve simplified procedures based on mutual recognition agreements with certain countries or regions, such as the United States, the European Union, and Japan.
The QSD is a critical component of the Regulatory framework for medical devices in Taiwan, ensuring that products meet the necessary quality and safety standards before they are allowed to be manufactured and marketed.
Frequently Asked Questions (FAQs)
In Taiwan, medical devices are classified into the following classes according to their risk level:
- Class I: Low-risk
- Class II: Medium-risk
- Class III: High-risk
The Medical Device Act in Taiwan is a legislative framework established to ensure the safety, effectiveness, and quality of medical devices used by citizens. It aims to promote public health and improve the management of medical devices within Taiwan. The Act defines the term "medical devices" and outlines the responsibilities of the competent authority, which is the Ministry of Health and Welfare at the central government level, as well as municipal and county/city governments at their respective levels. The Act includes provisions for the registration, manufacturing, advertisement, tracking, recall, and safety surveillance of medical devices, as well as the management of medical device technicians and the penalties for non-compliance with the Act's regulations.
To Register a medical device in Taiwan, one must follow the process below:
- Device Classification: Classify the medical devices according to the TFDA regulations.
- Documentation Preparations: Compile the necessary documents based on the class of the device.
- QMS: QMS standards should be provided for compliance with the medical devices.
- Application Submission: Online application submission through TFDA’s online application platform.
- Certificate Submission: Submission of certification (If applicable) to the authorized agent in Taiwan.
- Payment: Payment of the application fees based on the application type.
- Review by the TFDA: The application is reviewed by the TFDA for Regulatory compliance.
- Issuance and Approval of the Licence: TFDA issues a medical device license for marketing in Taiwan upon approval.
No, Taiwan has its own Regulatory framework for medical devices and does not require a CE mark, which is specific to the European Union. Instead, medical devices in Taiwan must comply with the regulations set by the Taiwan Food and Drug Administration (TFDA) and obtain market approval from the TFDA before they can be sold in Taiwan.
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Taiwan Quality Management System (QMS)
- QSD Implementation
- Gap Analysis & Documentation
- QMS Maintenance Support for NC Closure and Change Control Management
- Internal Audit & Supplier Audit Support