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It is a well-known fact that the approval authorities put their sweat before market success . In concrete terms, this means for the Chinese market that medical technology 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. And as if that wasn't enough, 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 should cover both aspects - Regulatory Affairs Updates and MAH from a regulatory point of view - equally. The current regulatory trends and the requirements for obtaining the "Made in China" label and the associated localization requirements are presented.
topic overview
- 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)
KONTAKT:
Online
