Regulatory Affairs in China and Taiwan
China and Taiwan are fast growing markets for medical devices with great potential and plenty of opportunities. However, the regulation systems for medical devices in China and Taiwan are complex, non-transparent and inconsistent. Sometimes the documentation requirements are determined on a case by case basis. It is also important to understand the culture and the environment in which the regulations are interpreted.
What makes it even more complex, is that not all regulations are translated into English and the ones that are translated are not always easily understood. Many companies have underestimated the complexity, so the launch of their products could be delayed, or they lose their share of the markets. To make your regulatory registration of medical devices and IVD:s in China and Taiwan successful, we provide you with a unique service with a regulatory specialist fluent in Chinese and experienced in regulatory issues related to China and Taiwan.
China has a lab test based regulation of medical devices and requires
- Product specified standards
- Type-testing
- Technical documentation
- Labelling in simplified Chinese
- Clinical trials
- Compliance with adopted international standards, such as ISO 13485, IEC 60601
Taiwan, R.O.China, has a quality system based regulation of medical devices and requires
- GMP compliance (QSD audit)
- Technical documentation
- Process documentation
- Clinical documentation
- Labelling in traditional Chinese
- Compliance with adopted international standards, such as ISO 13485, IEC 60601
Our services
- Product registration – full process (product documentation for registration submission, translation of registration dossier, identification of registration agents, distributor, establishing product standard, application for sample-product import permission for registration test, assistance of type-testing, labelling issues, coordination of all related activities)
- Product registration – part of the process, any of the above •Application for GMP compliance certificate in Taiwan
- Labelling
- Translation of technical documents into Chinese (both simplified and traditional)
- Courses on Chinese and Taiwanese regulations of medical devices and IVD devices
- Coordination between you and your partner in China and on Taiwan
About our consultant for the Chinese and Taiwanese regulations, Lian
Lian has experience in regulatory of In Vitro Diagnostic medical devices and medical devices in the EU, China, Taiwan and other countries, regarding conformity assessment, product documentation for registration submission, labeling, regulatory assessment with product modification, project support with regulatory issues and ISO13485 compliance.
Lian’s foremost strength is his strategic work that leads to regulatory compliance within product development and successful product registrations in the concerned countries. With his good competence in regulatory affairs, he is a valuable resource in opening new markets for business growth. He has a special focus on the Chinese and Taiwanese markets where he has an extensive experience combined with being fluent in Chinese.