Japan – Japan updates guidance on QMS Conformity Survey applications

Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for a quality management system (QMS) Conformity Survey.

What documents are manufacturers required to submit with a QMS Conformity Survey?

Several notices (links in Japanese) from MHLW explain these revised requirements. First, a new piece of guidance updates the list of documents that manufacturers must submit when applying for a QMS Conformity Assessment using the Gateway System. Only Japanese Market Authorization Holders (MAHs) and manufacturers can access the Gateway System…