Authorized representatives play a crucial role in the NMPA registration process for medical devices in China. Their main functions include:
Local Liaison: They act as the main point of contact between the manufacturer and the NMPA, facilitating communication and handling administrative tasks.
Regulatory Compliance: They ensure that the manufacturer's product complies with Chinese regulations and standards.
Document Handling: They assist in preparing and submitting the required documentation for registration and manage any required updates.
Post-Market Surveillance: They support ongoing compliance by managing adverse event reports and other post-market requirements.
Inspection Support: They help coordinate and facilitate any inspections or audits required by the NMPA.
Their involvement is essential for navigating the regulatory landscape and ensuring successful registration and market access in China.
Contact Us：
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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