Mission

The medical industry in Japan is undergoing a time of momentous change. Revisions to the Pharmaceutical Affairs Law, changes to payments for medical service and official prices based on the health insurance system, and the ongoing population changes of a dwindling birthrate combined with an aging population are just some of the recent developments. MedTec Engineering Co., Ltd. is a company that specializes in pharmaceutical research and development. Our client roster includes large, small and medium-sized enterprises; venture companies; and foreign-affiliated medical-device manufacturers. Backed by an extensive track record and a wealth of expertise, MedTec Engineering provides outstanding service and support as a consultant, handling submissions for approval and authorization of medical devices and other products under the Pharmaceutical Affairs Law, submission of applications for approval and certification, clinical trials, quality assurance, pharmacovigilance and marketing. To meet and exceed the diverse range of customer requirements and expectations, MedTec Engineering provides the latest information and works diligently every day to provide assistance tailored to customer needs.

Our Businesses

  • Import, export, production, sale or leasing, or agency operations for any of the aforementioned, for medical devices, veterinary equipment, medical diagnostic pharmaceuticals, industrial chemicals, cosmetics, social-services tools and medical sundries
  • Consulting on submissions for approval of manufacturing, import, repair, sale or leasing operations for any of the above products
  • Consulting on research and development, planning and design, clinical trials, submissions for advanced medicines, submissions for application of medical insurance or patent-submission operations for any of the above products
  • Consulting and various auxiliary operations on quality control, quality assurance, risk management, personnel training or market research for any of the above products

Supported Services

  • Formulation of pharmaceutical strategy
  • Formulation of marketing strategy
  • Design of clinical trials
  • Preparation of written applications in the MHLW and submission of Quality Management Systems (QMS)
  • compatibility studies
  • Pharmacovigilance (GVP)
  • Good Clinical Practice (GCP) reliability studies on clinical-trial data
  • Submissions for approval of the MHLW
  • Studies related to the MHLW for M&A purposes (succession procedures)
  • Support for development of medical devices, medical welfare devices and nursing-care devices
  • Submissions for application in health insurance
  • Customs clearance operations for import/ export medical devices and etc
  • On-the-job training in pharmaceutical affairs, quality assurance and quality control
  • Preparation of manuals for Good Quality Practice, Good Veterinary Practice, QMS, ISO, GCP and Quality Control

Management Policy

  • We introduce new technologies and products at an early date, to improve patient quality of life.
  • Drawing on extensive experience, we introduce new technologies and products at an early date to physicians and other medical practitioners.
  • We establish liaison among industry, academia and government, and between medicine and industry, cultivating mutual partnerships enabling the provision of services that bring confidence and peace of mind to patients.
  • Focusing on win-win teamwork, based on trust and respect both within and outside organizations, we maintain mutually respectful personal relations.
  • Persisting in utmost effort, lifelong learning and lifelong service, we constantly maintain a spirit that embraces challenge and innovation.

Corporate Profile

History

January 1997:    Medical -Care Welfare Engineering Research Office established by Shigenobu Teranishi as General Manager (at present)
July 2004:         MedTec Engineering Co., Ltd. established by Shigenobu Teranishi as president and C.E.O (at Present))

Company name MedTec Engineering Co., Ltd.
Head office 505B Stage Tamagawa, 2-4-5 Yaguchi, Ota-ku, Tokyo 146-0093
Tel./Fax 03-3750-7137
URL www.medtec-eng.co.jp
E-mail info@medtec-eng.co.jp
Capital ¥3,000,000
Date established July 2004
Representatives Representative director Shigenobu Teranishi
Director　Michiko Teranishi