Business License Support
Business License Support
Manufacturing and selling medical devices in Japan requires various licenses, registrations, and notifications under the Pharmaceutical and Medical Device Act (PMD Act). MK Consulting provides end-to-end support — from manufacturing and marketing licenses to manufacturing registrations and sales notifications.
Service Overview
Under the PMD Act, all entities involved in manufacturing or selling medical devices in Japan must obtain the appropriate license, registration, or notification based on their business activities. Obtaining these licenses requires establishing proper organizational structures, facilities, and personnel (including Responsible Technical Supervisors and Quality Assurance Managers), as well as specialized knowledge for preparing application documents and liaising with regulatory authorities. MK Consulting provides comprehensive support — from preparation through application and approval — for overseas companies entering the Japanese market and domestic companies expanding their operations.
License Types We Support
Manufacturing and Marketing License
Class 1 / Class 2 / Class 3
Required to place medical devices on the Japanese market. Classified into Class 1 (highly controlled), Class 2 (controlled), and Class 3 (general) based on device risk classification.
- Appointment of a General Manufacturing and Marketing Supervisor (education/experience requirements apply)
- Establishment of Quality Assurance and Safety Management departments
- Quality Management System (QMS) implementation per QMS Ordinance
- Application to: Prefecture (Class 3) or Minister of Health, Labour and Welfare (Class 1 & 2)
Manufacturing Registration
Domestic / Foreign Manufacturing
Required for manufacturing medical devices (including assembly, sterilization, and storage of finished products). Classified into domestic and foreign manufacturing registrations.
- Appointment of a Responsible Technical Supervisor (education/experience requirements apply)
- Establishment of appropriate manufacturing facilities and equipment
- QMS implementation aligned with manufacturing processes
- Application to: Prefecture (domestic) or Minister of Health, Labour and Welfare (foreign)
Sales and Leasing Notification
Highly Controlled Medical Devices
Required for selling or leasing highly controlled medical devices (Class III & IV) and specially maintained medical devices. Requires appointment of a manager who has completed the required training.
- Appointment of a Sales/Leasing Manager (completion of required training course)
- Notification per sales location
- Application to: Prefecture
Repair Business License
Medical Device Repair
Required for conducting medical device repairs as a business. Classified by the type of medical devices being repaired.
- Appointment of a Responsible Technical Supervisor
- Establishment of facilities and equipment appropriate to repair categories
- Application to: Prefecture
Our Process
Current State Analysis & License Identification
We analyze your business activities, products, and organizational structure to identify the required license types and application requirements under the PMD Act.
Organizational & Personnel Requirement Support
We verify requirements for General Manufacturing and Marketing Supervisors, Responsible Technical Supervisors, and Quality Assurance Managers, and support appropriate personnel placement and organizational setup.
QMS Implementation Support
We support the development and documentation of a Quality Management System based on the QMS Ordinance (equivalent to ISO 13485).
Application Document Preparation
We prepare or review license applications and supporting documents. We also support pre-application consultations with regulatory authorities.
Submission & Regulatory Liaison
We manage submissions to prefectural governments and the Ministry of Health, Labour and Welfare, and handle reviewer queries throughout the review process.
Post-License Support
We provide ongoing support for change notifications, renewal procedures, and periodic compliance maintenance under GQP and GVP Ordinances.
Why MK Consulting
Proven track record in obtaining various medical device business licenses
Specialized support for overseas companies entering the Japanese market
One-stop service from QMS implementation to license application
Practical advice based on experience liaising with prefectures and the MHLW
English support available (for overseas manufacturers and foreign marketing authorization holders)
Ongoing support for post-license change notifications and renewals
FAQ
Q1How long does it take to obtain a Manufacturing and Marketing License?
Including document preparation, the process typically takes 3–6 months. The timeline varies depending on the state of your organizational and QMS setup. Pre-application consultations with regulatory authorities can help streamline the process.
Q2What licenses does an overseas company need to sell medical devices in Japan?
Overseas companies must either establish a domestic marketing authorization holder (a company with a Manufacturing and Marketing License in Japan) or contract with an existing one. If manufacturing is conducted overseas, a Foreign Manufacturing Registration is also required.
Q3What if we don't have personnel who meet the requirements for General Manufacturing and Marketing Supervisor?
The General Manufacturing and Marketing Supervisor must meet specific education and experience requirements. We can advise on recruiting and developing qualified personnel. We can also advise on contract manufacturing and marketing arrangements.
Q4We already have a Manufacturing and Marketing License. Do we need to change it for a new product category?
Depending on the device classification, you may need to upgrade your license class (e.g., from Class 3 to Class 2 or Class 1). We will review your current license and new product requirements and advise accordingly.
Consult Us About Your Business License
Start with a free consultation. We'll identify the licenses you need and outline the path to obtaining them.