MD&DI's Guide to Outsourcing contains an interesting article on some of the challenges faced by medical device manufacturers in Japan.
When the "new" Pharmaceutical Affairs Law went into effect in Japan in 2005, it introduced new requirements for regular quality management system (QMS) audits. Administered by Japan's Pharmaceutical and Medical Devices Agency (PMDA), medical device manufacturers can be subject to paper or on-site audits. Without a good understanding of Japanese regulations and culture, device companies could fail to get their products registered.
The article highlights some of the challenges around on-site audits:
- SOPs for the manufacturing site are a key element and are regularly examined. Rather than simply handing over Japanese versions of the documents, it is advisable to prepare summaries in both English and Japanese.
- The same thing is true for product application dossiers and other QMS documentation: Manufacturers will have prepared Japanese versions of these documents but should also have English versions for their own use.
- Manufacturers overlook cultural issues at their own risk! Auditors are used to receiving the respect of the companies they visit. And because they enjoy wide leeway in interpreting regulations, it is wise to show plenty of respect.
It pays to be fully prepared for a medical device registration by fully understanding the QMS auditing process in Japan!
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