In April 2021 Taiwan Food and Drug Administration (TFDA) released the Medical Device Quality Management System Regulation that separated the control of medical devices from the "Pharmaceutical Good Manufacturing Practice Regulations". Therefore, the requirements for the quality management system (QMS) for both, domestic and foreign manufacturers shifted from ISO 13485:2003 to the more commonly applied standard ISO 13485:2016.
Before a medical device can be sold in Taiwan, Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration. QSD registration is only waived for Class I (non-sterile) medical devices. A QSD license in Taiwan - received upon QSD registration approval - is similar to Good Manufacturing Practice (GMP) for medical devices.
Taiwan GMP is mandatory for all medical device manufacturers who want to sell their products in Taiwan, while 13485:2016 is voluntary and can be used as a means for medical device manufacturers to demonstrate their commitment to quality and regulatory compliance.
While there is some overlap between Taiwan GMP and ISO 13485:2016, there are some differences between the two. Taiwan GMP demands compliance with local requirements, for instance: handling of patient records in accordance with Taiwan Personal Data Protection Act, UDI for medical devices as a traceability method, vigilance reporting, and the undertaking of corrective and preventive measures.
Medical device manufacturers located in the EU may utilize the well-known Technical Cooperation Program (TCP) between EU Notified Bodies and Taiwan FDA by providing an ISO 13485:2016 certificate and audit report to TFDA Authorized Auditing Organizations. The audit report replaces the requirement to submit QMS documentation for the purpose of product registration in Taiwan which significantly reduces the time and cost in demonstrating compliance with requirements.
The cooperation mechanism was started in 2005, and many Taiwanese and EU medical device manufacturers have benefited from the TCP by reliance on the audit reports issued by TCP partners. The TCP on Exchange of Medical Device GMP and ISO 13485 Audit Reports between EU AIMD/MDD/IVDD Notified Body Partners and R.O.C. TFDA Authorized Medical Device GMP Auditing Organization was known as TCP II.
In response to the implemented Taiwan Medical Devices Act (01 May 2021) and the EU MDR 2017/745 (26 May 2021) application dates, the TCP II was expected to becoming a TCP III by 25 May 2021 but was announced as effective later, in January 2022. At this moment, 6 EU Notified Bodies participate in TCP III and therefore TFDA Designated Auditing Organizations may delegate their foreign audits to these Notified Bodies.
In order to get prepared for such an audit, we invite EU manufacturers to reach out to Qserve. Our consultants specialize in regulatory compliance and can provide expert knowledge and experience in preparing for and managing Taiwan GMP Mock audits. Qserve can offer valuable guidance in meeting Taiwan FDA regulations and identifying areas of potential noncompliance as Qserve provides an independent and objective assessment of the manufacturer's QMS. There are two services Qserve offers:
- Taiwan GMP Mock Audit, which will include the specific aspects of the manufacturer’s QMS with regard to the products intended to be marketed in Taiwan.
- The requirements of Taiwan GMP and other applicable TFDA regulations can be added to the regular Mock MDSAP audit (MDSAP++ service).
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