What certification is needed for medical pure butyl gloves exported to Japan?

Medical gloves are classified as Class 1 medical devices, to do?MAH application and obtain FMR certificate.

Medical device products placed on the Japanese market must meet the Japanese Pharmaceutical and Medical Device Act (PMD Act).

The PMD Act requires foreign manufacturers to apply for registration of their manufacturing sites with the PMDA and obtain a foreign manufacturer registration (FMR) certificate. The FMR certificate is a requirement when submitting an application for registration of a medical device and must be obtained prior to filing an application.

Japan's Marketing Authorized Holder (MAH) system requires that an MAH license for a class of products be obtained before a marketing application for a specific product can be filed

And a class of medical devices (a pre-market registration application must be submitted to the PMDA. The application is a notification document and PMDA will not make any review comments.

Registration process:

? 1. Determine the product category

Determine the classification of the device according to the PMD Act and the Japanese Medical Device Nomenclature (JMDN) code.

? 2. Authorized Agent

For Class I devices, designate an MAH in Japan; for other classes of devices, designate an MAH or D-MAH to manage the Japanese device registration.

? 3. Manufacturer Registration

Japanese manufacturers submit Manufacturer Registration (MR) applications to local authorities. Foreign manufacturers submit Foreign Manufacturer Registration (FMR) applications to PMDA.

?4. Quality Management System

Implementation of a Quality Management System (QMS) requires compliance with the PMD Act and MHLW Regulation No. 169. QMS audits are not required for Class I devices. Class II devices are QMS audited by a Registered Certification Body (RCB). QMS audits are conducted by PMDA for Class II (except for special controls), Class III, and Class IV devices. New devices that do not have a JMDN code, Class IV devices, or devices that require clinical trials are usually subject to a QMS on-site review.QMS certificates are valid for five years and are renewed six months prior to expiration.

?5. Submission of Marketing Application

Pre-market notifications are submitted to PMDA for Class I devices. Class II devices submit an application for pre-market certification to the Registered Certification Body (RCB). Class II (except for special controls), Class III, and Class IV devices submit an application for premarket approval and a registration dossier in STED (Summary Technical Document) format to PMDA. All submissions must be in Japanese.

6. Issuance of Certificates

Certificates of premarket approval are issued by RCB for Class II devices. Class II (except for special controls), Class III and Class IV devices are issued a Certificate of Premarket Approval by the MHLW. There is no expiration date on device registrations.

7. Sales

Medical devices enter the Japanese market for sale.