Navigating the Regulatory landscape for medical device registration in China can be a complex process, especially for foreign manufacturers. One of the most critical steps in ensuring compliance with Chinese Regulatory requirements is the appointment of a China agent. This blog will provide a comprehensive guide on why you need a China agent, their key responsibilities, and the process of appointing them for medical device registration in China.
As a big face lift, Health Authorities of China and South Africa have recently revealed their identifications. The China Food and Drug Administration (CFDA), has recently announced the change related to the agency’s official English name, the National Medical Product Administration (NMPA). Similarly, South Africa’s Medicines Control Council (MCC) has officially concluded that MCC has transferred its supervisory responsibilities to a public entity, the South African Health Products Regulatory Authority (SAHPRA). What led to these changes? Let’s learn in detail.
On August 1, 2018, China Food and Drug Administration (CFDA) - the Chinese health authority, has taken a major step towards classification of medical devices to be marketed or currently being marketed in China. The CFDA has officially published and mandated the new Medical Device Classification Catalog. To be on par with continuous changes in regulations for medical devices and considering the innovation taking place in the global life sciences sector, the CFDA has initiated updating their earlier catalog which was published in the year 2002.
Gear up to be Compliant
The future of Pharma Regulations has never been so complex and challenging and at the same time has never been so easy-to-deal with provided the burgeoning section of Regulatory Intelligence service providers feeding the industry with continuous health authority updates and requirements. Setting forth clear cut guidelines to be compliant all across, various health authorities (HAs) worldwide released many guidelines for the manufacturers and pharma companies.