“Made in China” current regulatory trends and requirements for medtech manufacturers will be presented in this webinar, held together with MedicalMountains GmbH on October 6, 2022.
China medical device registration approvals are increasing each year. In 2021, 11,314 medical device registrations were approved, of which over 1,700 were new initial registrations. Medtech manufacturers have to deal intensively with the regulatory requirements. The constant further development of regulations for approval and post-market surveillance make it essential to deal with the topic on an ongoing basis. The current “Made in China” requirements pose further challenges that require the localization of the products and the establishment of a Market Authorization Holder (MAH).
The focus of this event covers both aspects – Regulatory Affairs Updates and MAH from a regulatory point of view.
Date and Time
October 6, 2022, 9:00am (Germany time)
- Secure access to the Chinese market
- Regulatory requirements of today and tomorrow
- Fit for “Made in China” – requirements to obtain the label
- Flexibility in localization
- Implementation of a Market Authorization Holder (MAH)
Mr. Stefan Fischer – Managing Director of the Cisema Group
The webinar will be conducted in German.
The process of China NMPA registration is complex, and can take from a few months to several years, depending on the product. The costs and the exact timeframe of the registration process varies, among all, on its classification and the testing required.
Even experienced companies could encounter unforeseen challenges. Our committed consultants can guide you through China’s regulatory processes, from identifying product classifications and preparing the application documents in Chinese to approval and issue of the NMPA certificate.
Cisema specializes in bypassing clinical trials in China. If clinical trials are mandated, Cisema can define the clinical trial criteria for your product, identify and coordinate with accredited laboratories, and ensure compliance with all regulations. The NMPA approval for medical devices is valid for 5 years. Learn more about the process of China NMPA registration including timeline and how Cisema avoids clinical trials in our brochures or contact Cisema directly.