About Us
Our company was established to deliver medical devices needed by healthcare professionals and contribute to QOL.
Our team includes specialists well-versed in pharmaceutical regulations in both Japan and the United States. Since we can handle almost all tasks from approval to selling required by authorities, we have contributed many companies to receive approvals from PMDA & FDA.
We can propose the most cost-effective way and the shortest period for Medical Device Approval for clients.
We will continue to contribute to the health and welfare of people through medical devices.
If you are considering selling medical devices in Japan, please feel free to contact us.
Our Business
Scope of Our business described blow:
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- Consultation related to Pharmaceutical affairs law.
(Medical Device approval to PMDA in Japan, PMS/QMS/Clinical trial, etc.) - DMAH（Designated Marketing Authorization Holder）service.
- Research & Development for Medical Device.
- Consultation related to Pharmaceutical affairs law.
Our team contribute to accelerate your business in Japan
Our Strength and Experiences
Our team have 40 years' experience of Medical Device approval/ certification, including most of the tasks related to Pharmaceutical Affairs Law:
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- Clinical Trials for Class IV Devices: 3T MRI, Bare Metal Coronary Stents, Drug Eluting Coronary Stents, ICD, etc.
- Class Ⅳ Device approval, using foreign clinical trials.
- PMS of Class Ⅳ Devices: Permanent implantable medical devices.
- Class III Device certification: Balloon Kyphoplasty Products with Clinical Evaluation Report, etc.
- Research and Development for Class Ⅳ devices: Permanent implantable medical devices.
Company Profile
| Company Name | Saikyo Biotech Co.,Ltd |
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| CEO | Kyoko Sawada |
| Location | 〒180-0022 Sakai 2-2-18 #403, Musashino City, Tokyo, Japan |
| Founded | Nov. 6th 2018 |
| Business Lisences |
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| Business summary |
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Contact
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