MK Consulting specializes in medical device regulatory affairs. We help with application strategy and PMDA consultations, dossier preparation, and responses to questions during regulatory review.
Our services also cover Clinical Evaluation Report (CER) preparation, QMS and reimbursement. In GI endoscopy and biliary-pancreatic devices, we draw on experience spanning product development through commercialization.
SERVICES
We review the Japanese generic device name, classification, and differences from existing devices and organize the application pathway, testing and clinical evaluation approach, and consultation questions for PMDA or a Registered Certification Body.
Based on the application strategy and current documents, we support preparation of application forms and technical documents, submission readiness, and review responses. Reviews of work in progress and support for selected tasks are also available.
Using literature, overseas clinical data, and existing test results where appropriate, we support the clinical evaluation approach and CER preparation in alignment with the full Japanese application dossier.
We support preparations for QMS conformity assessment, Marketing Authorization Holder licensing, manufacturer registration, and foreign manufacturer registration according to the product and business structure.
We support development and improvement focused on plastic stents, consultations on patent applications, and regulatory work for GI endoscopy and biliary-pancreatic devices.
CONSULTATION STAGES
Based on product information, we review the Japanese generic device name, JMDN code, classification, and the existence of a certification standard, then consider whether approval, certification, or marketing notification may apply. Where needed, we also organize questions for PMDA or a Registered Certification Body.
We review approval and marketing status outside Japan, technical documents, and test results, and distinguish documents that may be used in Japan from additional actions that may be required.
We support preparation of PMDA consultation materials, Clinical Evaluation Reports (CERs), and application documents, as well as responses to review questions and preparation for QMS conformity assessment.
STRENGTHS
Beyond explaining the rules, we organize the regulatory issues, required documents, and priorities in concrete terms according to the product characteristics and business plan.
CONTACT
We review the product overview and current progress and explain the regulatory procedures, documents to prepare, and next matters to consider.