MEDICAL DEVICE Regulatory Service Line Up -- Inbound to Japan

1.) Japan Medical Device Regulatory Research and Consulting:

The first step in understanding the Regulatory requirements and PMDA process for your device or technology, along with Reimbursement Research and Consulting. We have a network of Key Opinion Leaders to help guide your Japan project. 

2.) Pre-application PMDA Meetings Service: 

Preparation for Preliminary and First Consultation meetings with the PMDA. Develops a clear understanding and pathway to device approval or registration.

3.) PMDA Approval and Registration Process:

Working with the top regulatory experts in Japan, we lead you through an effective and PMDA application process. Includes GAP analysis, DMAH, MAH relations management, Regulatory Application Management.

4.)  Corporation Set Up and Management:

KK and GK set up and representation with our network of seasoned professionals. Our network of multilingual experts can help you quickly and effectively set up a Japanese subsidiary which makes you a real player in the market. 

5.) Distribution Chain Development:

Japan's medical device distribution chain is characterized by a local distributors who are close to the local doctors, hospitals and clinics. Parkdale Group help you develop a supply chain so that your products are close at hand. 

6.) Japan Technology Business Development:

The Japanese medical establishment is looking for companies that can help them realize real digitization of medical and health care records. Parkdale Group Inc. can help you make connections with Key Opinion Leaders in Japan. 

7.) Japan PMDA Training:

Live on-line training programs that give you and your organization the insights you need to effectively work with Japan's world-leading regulator: the PMDA.