Medical device manufacturing and sales approval/certification
Navigating the Japanese medical device market requires a deep understanding of the country’s pharmaceutical and medical device regulations, along with specialized knowledge in various medical device sectors.
Our team of professional consultants is dedicated to staying abreast of the dynamic legal landscape, regulatory changes, and industry trends. We aim to assist our clients in overcoming resource constraints.
The Japanese medical device market offers numerous advantages. With an aging population driving demand for medical devices, Japan represents a lucrative market for foreign enterprises specializing in home healthcare and elderly care technologies. The country’s advanced medical industry also opens doors for the introduction of innovative products in a market that prioritizes quality and technological advancement. Moreover, Japan’s political stability and robust legal framework provide a secure setting for long-term investments, making it an appealing gateway for companies aiming to penetrate the Asian market.
We provide a comprehensive suite of services, ranging from startup assistance for those looking to market medical devices in Japan, to specialized support for medical device manufacturers.
For companies looking to enter the Japanese market through medical equipment sales, let us handle the intricate local procedures for you!
Our Service
Our company provides comprehensive support services centered on medical device-related operations, including:
- Medical Device Manufacturing and Sales License Application Support:
Assisting with applications to prefectural governments. - Medical Device Manufacturer Registration Support:
Facilitating applications to prefectural governments. - Foreign Manufacturer Registration Support:
Aiding in applications to the Pharmaceuticals and Medical Devices Agency (PMDA). - Medical Device Marketing Authorization Notification Support:
Assisting with notifications to the PMDA. - Medical Device Certification Application Support:
Supporting applications to third-party certification bodies. - Medical Device Approval Application Support:
Helping with applications to the PMDA. - QMS & GVP Procedure Documentation Support:
Assisting manufacturers in developing required procedure documentation.
We also specialize in:
- Medical Device Classification and Eligibility Investigations:
Conducting research on medical device classification and eligibility. - Medical Device Approval Acquisition Planning:
Creating plans and budgets for obtaining approval or certification. - Evaluation Test Implementation Support:
Providing support for conducting evaluation tests through external testing organizations.
Procedure flow
Consultation and Quote
Please contact us via phone or our online form to start. We’ll schedule a meeting either in person or via web conference to understand your current situation and provide initial advice. During this meeting, we’ll delve into your specific needs and requirements for your application, followed by presenting a fair quote based on our findings.
Application
Once you’re satisfied with our quote and service details, you can proceed with your request. Please discuss payment schedules and any success-based fees with your assigned consultant.
Document Collection and Preparation
We will prepare all necessary documentation for manufacturing and sales license applications, including details on manufacturing facilities and staffing requirements. Our team will handle meetings with regulatory bodies and prepare all application and supporting documents on your behalf.
Application Submission
Our administrative scriveners will submit the application for you, collecting any application fees upfront. We will also handle any requests for additional documentation.
Review Process
The review process includes onsite inspections, with our staff present to provide support and ensure all preparations are in place. Should any corrections or additional documents be required, we will address these. Typically, the review process takes about 2-3 months if there are no issues.
License Notification
Upon successful review, you will receive your license, valid for five years.
Product-Specific Procedures
For Class I medical devices, we will submit a marketing notification. For Class II to IV devices, we’ll handle marketing authorization, certification applications, and QMS conformity assessment with third-party organizations or the Pharmaceuticals and Medical Devices Agency (PMDA).
Market Entry
Class I devices can be marketed upon notification acceptance, while Class II to IV devices may be sold once marketing authorization and certification are granted. Our team supports your entry into the medical device market every step of the way.