Overview Taiwan has a growing demand for Medical Devices. The Taiwan Food & Drug Administration (TFDA) under Ministry of Health and Welfare (MOHW) regulates Medical Devices through Pharmaceutical Affairs Act (PAA). The agency classifies the devices into 3 classes based on risk. Class-I for low-risk, Class II for moderate-risk and Class III for high-risk devices. The need for a predicate device to market poses challenge for novel devices to enter the market. Increased procedural time gap for Class II and III devices needing Quality System Documentation is another complexity involved. Freyr specializes in catering to Regulatory needs of Medical Devices in Taiwan. With extensive network, Freyr helps in appointing a reliable local agent whose presence is of utmost importance throughout the post-marketing surveillance. Our experts also assist in selection of suitable predicate device and existing approvals from other markets to support new device market entry. Taiwan Market Entry for Medical Devices - Process Flow Freyr Expertise Regulatory Support in Registration Process Medical Device Classification Taiwan Local Authorized Representation Regulatory Assistance for Quality System Documentation (QSD) Registration Post-Market Surveillance Summary S. No Regulatory Parameter Taiwan 1 Regulatory Authority TFDA 2 Regulation Pharmaceutical Affairs Act (PAA) 3 Risk Classification Class I Class II Class III 4 Regulatory Pathway Class I Product Registration Class II & III QSD + Product Registration 5 Authorized Representative Taiwan Agent required 6 Fee payable Class I ~ $ 350* Class II ~ $ 860* Class III ~ $ 1310* QSD ~ $ 1310* 7 QMS Requirement Quality System Documentation (QSD) ISO 13485 8 Assessment of Technical Data Division of Medical Devices & Cosmetics 9 Validity of License QSD 3 Years Product Registration 5 Years 10 Labelling Requirements Article 75, Pharmaceutical Affairs Act 11 Submission format Paper 12 Final Outcome Medical device permit license. 13 Timelines QSD 6 months Product Registration 1 - 2 years 14 Language English & Chinese *This price is as per records at the time of documentation and is subject to change.