The Medical Devices and Cosmetics division of the Taiwan Food and Drug Administration (TFDA) controls the safety and quality of medical device marketed in Taiwan using the current regulations according to Article 13, paragraph 2 of the Pharmaceutical Affairs Act. Medical devices are classified based on their risk level in three classes whereas class I is low risk, class II is medium risk and class III is high risk. Taiwan regulations also classify medical devices based on their function, intended use and working principle into different product categories like for example neurological devices, orthopedic devices or cardiovascular devices.    

An authorization letter needs to be issued by the foreign legal manufacturer to the importer mentioning the medical device models and specification.  

Local license holder 

Companies without an establishment in Taiwan are required to appoint a local authorized representative. This product license holder must own a pharmaceutical firm permit license and will be the local responsible person for the medical device. 


The language of the submission files shall be either in English or in traditional Chinese. Labeling should always be in traditional Chinese, also for medical devices only used by professionals. 


The Ministry of Food and Drug Safety (MFDS) is the authority responsible for medical device vigilance and quality control and enforces the Korean Medical Device Act (MDA). Classification of medical devices is based on potential risk to human health and gives four risk classes whereas class I devices know little risk, class II devices low risk, class III devices moderate risk and class IV devices high risk.  The low risk devices can, as long as it does not concern new medical devices without any substantial equivalent,  generally be certified by the Medical Device Information and Technology Assistance Center (MDITAC). Other class II and also the class III and IV medical devices will be reviewed by the Natioanl Institute of Food and Drug Safety Evaluation (NIFDS).  

A Korean Quality System (KGMP) audit, similar to the ISO13485, needs to take place in when placing class II or higher devices on the Korean market. This is in most cases an onsite inspection at the location where the medical device is manufactured.  

Local license holder 

Companies without an establishment in Korea are required to appoint a local authorized representative. They regulations state that a company that is intending to import medical devices shall obtain both an import business license as a product import license and have facilities for quality testing and a quality management system in place. 


All documents to be submitted in support of product registration must be provided in English and all information on the labels and instructions for use of medical devices supplied in Korea must be provided in the Korean language.

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