Drugdu.com expert's response:

Exporting Class II Medical Devices to Japan requires compliance with Japan's Pharmaceutical and Medical Device Act (PMD Act). Here are the primary qualifications and steps required:

Determining Product Classification and JMDN Code: According to the PMD Act, medical devices are classified into I, II Special Control, II Controlled, III, and IV categories. It is necessary to determine the specific classification and JMDN code for the exported Class II medical devices.

Manufacturer Registration: Foreign manufacturers must register their manufacturer information with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), including details on product design, production, and key processes.

QMS Factory Audit: For Class II Special Control products, an application for a Quality Management System (QMS) factory audit must be submitted to the authorized certification body, PCB. For other Class II products, as well as Class III and IV products, an application for a QMS factory audit must be submitted to the PMDA, and a QMS certificate must be obtained.

Pre-Market Approval Certificate: An application for a Pre-Market Approval (PMA) certificate must be submitted. For Class II Special Control products, the certificate is issued by PCB. For other Class II products, as well as Class III and IV products, the certificate is issued by the Ministry of Health, Labour and Welfare (MHLW).

Import Notification Registration: All categories of medical devices require import notification registration by the Marketing Authorization Holder (MAH) in Japan with the Regulatory Affairs and Healthcare Products Division of MHLW (RBHW) before they can be imported and sold.

Foreign Medical Device Manufacturer Accreditation Certificate: To export medical devices to Japan, a "Foreign Medical Device Manufacturer Accreditation Certificate" must be obtained to allow for import. This certificate is valid for five years and can be applied for by the Japanese importer on behalf of the foreign manufacturer, with fees varying depending on the product.

In addition, during the preparation for export, attention should also be paid to the following matters:

Ensuring product quality complies with relevant Japanese standards and regulations.

Preparing complete technical documents and registration materials, including product manuals, test reports, QMS certificates, etc.

Complying with Japanese import and sales regulations to ensure product compliance.

In summary, exporting Class II medical devices to Japan requires meeting a series of stringent qualifications and registration requirements. It is recommended to fully understand Japan's relevant regulations and standards before exporting and to consult professional medical device registration agencies or lawyers to ensure compliance.