QMS & LICENSING
QMS concerns the quality management system. A Marketing Authorization Holder license concerns the business operator; manufacturer and foreign manufacturer registration concern manufacturing sites. We review the product and business structure to identify the preparations needed and clarify each company’s responsibilities.
Businesses establishing their Japan operating structure or preparing QMS assessments, licenses and manufacturing registrations.
We review your product and the documents you have, then agree with you on the tasks we will undertake.
To market a medical device in Japan, it is necessary to confirm not only the product-specific approval, certification, or marketing notification but also the Marketing Authorization Holder, manufacturing sites in and outside Japan, and the quality management system.
If issues with the business structure or QMS are identified only after application preparation has advanced, the timing of market launch may be affected.
We organize the necessary licenses, registrations, and QMS actions while reviewing the product's application pathway and supply structure.
We compare existing quality documents with actual workflows and support the preparation or revision of procedures and forms, record organization, and preparation for audits and assessments. For ongoing development, we distinguish missing documentation from activities that still need to be performed and recorded, and agree our scope with regard to the responsibilities of the Marketing Authorization Holder and manufacturing sites.
We confirm the license category and organizational structure required to handle medical devices in Japan as a Marketing Authorization Holder.
We review the manufacturing processes and sites and assess whether registration is required for manufacturing sites in Japan or outside Japan.
We discuss with each company the responsibilities and methods of information sharing between the overseas manufacturer and the Japanese business operator for quality information, adverse event and complaint information, change control, and manufacturing-site information.
For medical device manufacturers preparing for initial ISO 13485 certification, we offer hands-on document preparation and help those who need to know what to prepare for the audit. MK Consulting is not a certification body.
Initial ISO 13485 certification involves different checks from preparations for Japan’s QMS conformity assessment and Marketing Authorization Holder licensing. We review the procedure you need and the current documentation and operating practices to agree with you on the tasks we will undertake.
For a quotation, please share the target product, current documentation and preparation status, the work you wish to request, and your preferred schedule. Based on this information, we propose the tasks we would undertake and how to proceed.
We review the target product, the Japanese marketing authorization structure, manufacturing sites in and outside Japan, and the manufacturing processes.
Based on the product's application pathway and the role of each party, we consider the licenses, registrations, and scope of QMS conformity assessment that may be required.
Using the existing quality system and documents, we agree with you on the materials to prepare for Japan and each company’s responsibilities.
We align progress on the product application and QMS activities and prepare the required documents, records, and information.
Responsibilities must be allocated with the Japanese Marketing Authorization Holder. We review the overseas manufacturer's quality system and manufacturing-site information and specify the actions needed in Japan.
Even with ISO 13485 certification, confirmation is required according to the product included in the Japanese application, manufacturing sites, manufacturing processes, and marketing authorization structure.
It is important to begin early and proceed in parallel with the product application. Delaying confirmation of the relevant manufacturing sites or quality documents may affect the schedule after submission.
CASE STUDIES
Client names and product details remain confidential. Each case distinguishes the work performed from the confirmed outcome.
Document revision and audit preparation completed
A case of creating and revising QMS documents and helping prepare for a third-party audit following amendments to the QMS Ordinance.
Share your product information, current business structure, existing licenses and registrations, and QMS readiness.
Contact us about QMS and business licensing