CMIC Co., Ltd. of Tokyo at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine
Service

CMIC Co., Ltd.

Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, 105-0023 Tokyo
Japan

Hall map

MEDICA 2018 hall map (Hall 16): stand C52

Fairground map

MEDICA 2018 fairground map: Hall 16

Contact

Yoshihiro Takizawa

International Business Development

1-1-1 Shibaura,Minato-ku,Tokyo 105-0023
Tokyo, Japan

Phone
+81-3-6779-8024

Email
yoshihiro-t.ta@cmic.co.jp

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.17  Other medical services and publications

Other medical services and publications

Our products

Product category: Other medical services and publications

Medical Device Regulatory Consultation

CMIC is the first and a leading contract research organization (CRO) in JAPAN. Our medical device experts offer one-stop regulatory consulting services to assist medical device, pharmaceutical or regenerative medicine companies access to Japan and the global market. We have introduced a wide range of medical devices into Japan through pre-submission meeting with the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) to optimize regulatory pathway and ensure that the Japanese regulatory requirements are fulfilled. 

As a pioneer in the Japanese CRO industry, CMIC is providing our clients with;

- Medical Device Product Development Services: Regulatory classification, Regulatory gap analysis, Performance testing (Bench, Animal, and Clinical) assessment, Regulatory authority meeting (PMDA/MHLW), Product registration submission and Approval (Japan Todokede/Ninsho/Shonin, EU CE marking, US 510(k)/PMA, and others), and Post-marketing surveillance.

- Medical Device Business Development Services: Medical device business license, Foreign manufacture registration (FMR), QMS establishment and audit, Designated marketing authorization holder (dMAH), In country clinical care-taker (ICCC), Reimbursement strategy and Value proposition activities.

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Company news

Date

Topic

Download

Aug 21, 2018

Webinar: Tips to Ensure a Successful Market Entry in Japan

CMIC group held a webinar “Tips to Ensure Market Entry Success in Japan” in May 2018.
The Japanese pharmaceutical market is world’s second largest market. Though it is a mature market like the US and Europe, it has its unique characteristics and regulatory requirements. This webinar will cover:
• Overview of current Japanese pharmaceutical market
• Highlight of recent regulatory changes
• Tips to conduct clinical trials in Japan
• Case Study: Key steps to ensure a successful market entry

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About us

Company details

CMIC Group was established in 1992 as the first CRO in Japan. Today it involves in close to 80% of new drug development and filing in Japan. Over the last 25 years, CMIC Group developed its unique “Pharmaceutical Value Creator” (PVC) business model based on the abundant experience and knowledge as a CRO pioneer, and now the company offers full services that encompass entire value-chain of pharmaceutical companies, including regulatory consultation, clinical research and operational support, clinical site management, drug development and manufacturing, sales, and marketing of pharmaceutical products. CMIC Group currently has over 6,000 employees, with offices and facilities in 10 countries, including US, Japan, South Korea, China, Singapore, etc. It also serves medical device companies, academia, bio-ventures, and medical institutions.

 CMIC Group continues to establish business models that create further value and contribute to greater advances in the medical industry including medical device, IVDs, and regenerative medicine. CMIC also contributes to a wide scope of health maintenance and enhancement measures incorporating prophylaxis, diagnosis, and treatment of diseases, like rare diseases.

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Company data

Sales volume

> 500 Mio US $

Number of employees

> 5000

Foundation

1992

Area of business

Medical Services and Publications