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…
