The validity period and management regulations of the Chinese NMPA certified Traditional Chinese Medicine Device License (中药器械注册证) typically include the following:
Validity Period: The validity period of the Traditional Chinese Medicine Device License is generally 5 years. This means the license is valid for 5 years from the date of issuance.
Renewal: Upon expiration, the license can be renewed through a similar application process as the initial registration. Renewal typically requires the submission of updated documentation and may include re-evaluation of the device's compliance with current regulations.
Post-Market Surveillance: After obtaining the license, manufacturers must comply with ongoing post-market surveillance requirements. This includes monitoring the device's performance, reporting adverse events, and ensuring continued compliance with Chinese regulatory standards.
Labeling and Changes: Any changes to the device or its intended use require approval from NMPA. This includes modifications to the design, manufacturing process, labeling, or intended clinical applications.
Quality Management: Manufacturers are expected to maintain a robust quality management system (QMS) throughout the validity period and beyond, ensuring consistent production and adherence to regulatory requirements.
Inspections: NMPA may conduct inspections of manufacturing facilities to verify compliance with regulations and standards.
These regulations aim to ensure the safety, efficacy, and quality of Traditional Chinese Medicine devices throughout their lifecycle in the Chinese market. It's essential for manufacturers to stay informed about any updates or changes in regulatory requirements to maintain compliance and market access for their products.
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