One of the main purposes of the recent revisions in Japan’s Pharmaceutical Affairs Law (PAL), which was passed into legislation in 2002, was to place a greater burden of responsibility for companies to assure quality. The Ministry of Health, Labor and Welfare (MHLW) has now established an original vendor or Marketing Authorization Holder (MAH) entity that will be solely responsible for the marketing and distribution of a medical product. The act of marketing and distributing will be completely separated from manufacturing. The new regulation requires the MAH to have office staff in Japan able to check for product quality, post-marketing review, adverse reactions, as well as other after market quality assurance standards.
The MAH can perform the following tasks in Japan:
- Conduct a business selling medical device equipment without a manufacturing license.
- Transact OEM sales.
- Purchase medical device products from a manufacturer.
- Sell and/or lease medical device products to businesses.
- Import medical devices.
- Store medical devices in Japan for future sale.
However, a MAH cannot manufacture medical products. Instead, the MAH must assume all responsibilities for the medical products it markets in Japan. Some of the MAH’s responsibilities include:
- Obtaining approvals for medical products.
- Assuring product quality in compliance with Good Quality Practice (GQP).
- Ensuring and confirming the quality systems in place at the productâ€™s manufacturing facilities.
- Developing release criteria for products and ensuring the manufacturer releases in accordance to the criteria.
- Retaining records for all products sold or leased.
- Complying with Good Vigilance Practice (GVP).
- Developing a Safety Management System.
- Conducting periodic evaluations of products, adverse event reporting (ADR), and recall reporting to the MHLW.
Through the introduction of the Japan MAH system for medical devices, the MHLW has effectively implemented a complete separation between MAHs and medical product manufacturers. Thus, ensuring greater checks and quality assurance on medical products marketed in Japan.