Taiwan Medical Devices License
According to the definition stipulated in “Regulations for Governing the Management of Medical Device” and “Enforcement Rules of Medical Devices Act”, medical devices include instruments, substances, software, in vitro diagnostic reagents and other related articles in Taiwan. The design and usage of the devices are aimed to achieve diagnosis, treatment or improvement of human bodies and human diseases by means of pharmacological, immunological, metabolic or chemical methods. If a company is intended to engage in wholesale or retail sales of the above-mentioned devises, it must apply for the Wholesale and Retail Sales of Medical Devices License with the Taiwan Ministry of Health and Welfare.
Ministry of Health and Welfare is the authority responsible for the issue and supervision of the Wholesale and Retail Sales of Medical Devices License.
Applicants shall fulfill certain criteria in order to apply for the license, including the business address of the company should be able to register for business activity code of medical devices wholesale and retail sales. Also, government officer will conduct onsite inspection on the business address.
In general, if the submitted documents and information are correct, the license will be issued with 4-6 weeks by the Ministry of Health and Welfare.
Wholesale and Retail Sales of Medical Devices License does not require a yearly renewal. However, if there are changes of business address, company representative and business activities, the company should report to the Ministry of Health and Welfare within one month and renew the license.
1. Businesses Required Taiwan Wholesale and Retail Sales of Medical Devices License
According to the definition stipulated in “Regulations for Governing the Management of Medical Device” and “Enforcement Rules of Medical Devices Act”, medical devices include instruments, substances, software, in vitro diagnostic reagents and other related articles in Taiwan. The design and usage of the devices are aimed to achieve diagnosis, treatment or improvement of human bodies and human diseases by means of pharmacological, immunological, metabolic or chemical methods. Medical equipment dealers are referring to sellers of the above-mentioned medical devices, including wholesale, retail, import, export, rental, and repair of medical devices.
In brief, any company which plans to engage in wholesale and retail of medical devises in Taiwan shall apply for the license with the Ministry of Health and Welfare in Taiwan.
2. Application Requirements