Once the head massager is registered with the Japanese PMDA, here are some important things you need to be aware of:
Compliance Continuity: It is important to maintain product compliance on an ongoing basis. Any changes to the product design, manufacturing process, or specifications may need to be resubmitted to the PMDA for approval. Ensure that your products continue to comply with PMDA regulations and standards.
Quality Management System: Ensure the effectiveness of the quality management system. Your company needs to continuously maintain and improve a quality management system to ensure that the manufacturing, testing, and distribution process of products is under control.
Market Monitoring and Safety Reporting: Conduct regular market monitoring to monitor the performance and safety of products in the market. In addition, regular safety reports may be required as required by the PMDA.
Labeling and packaging: Inspect product labels and packaging to ensure they comply with PMDA regulations and provide accurate information, including instructions for use, expected results, safety precautions, and more.
Adverse Events and Recalls: If there are issues or adverse events regarding product safety, ensure that they are reported to the PMDA in a timely manner and appropriate action is taken as needed, which may include product recalls.
Regulatory Updates: Stay tuned for regulatory updates and guidance issued by the PMDA and other relevant agencies. Ensure that your products and business are always compliant with the latest regulatory requirements.
Local role: If you have a local, work closely with them to share information about product changes, adverse events, and more to ensure that they can effectively perform their responsibilities.
Communication with PMDA: Maintain positive communication with PMDA, respond to their requests in a timely manner, and assist with any issues.