Lumbar massagers are registered with the PMDA in Japan and there are a number of requirements to ensure the safety, effectiveness and quality of the product. The following are general requirements, which may vary depending on the nature of the product, classification, and regulatory changes:
Technical Documentation Preparation: Provide complete technical documentation, including product specifications, design and manufacturing processes, material information, performance testing, safety and efficacy data, etc. The integrity of the documents is essential for the success of the registration.
Quality Management System: Establish and maintain a quality management system that complies with international standards (e.g., ISO 13485). Ensure that the process of manufacturing and quality control is effectively monitored.
Product Labels and Instructions: Provide product labels and instruction manuals that comply with PMDA regulations. Labels and instructions should clearly and accurately describe the product's purpose, method of use, safety precautions and other information.
Safety and efficacy data: Provide relevant safety and efficacy data. This may involve clinical trial results, biocompatibility testing, and more.
Local**: If you are a foreign manufacturer, you will usually need to appoint a local ** with a registered address in Japan that will represent your company during the PMDA registration process.
Application**: Complete and submit an application for registration as prescribed by PMDA**. Ensure that the information provided is accurate and complete.
Registration Fees: Pay the relevant registration fees, the amount of which may vary depending on the classification and complexity of the product.
Review Process: Submitted documents will be reviewed by PMDA. This may include a careful examination of documentation, possible testing requirements, and communication with the manufacturer.
Compliance testing: Some compliance testing may be required to ensure that the product complies with the relevant technical standards and regulations.