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Introduction

In the field of medical devices, a number of innovative products have been created with the development in medical technology. To sell and use these new devices in the medical sites, the effectiveness and safety evaluations and the procedures for approval, certification or notification submission of marketing business shall be required based on the Pharmaceutical Affairs Law (PAL). Especially, preparing documents with consideration of standards and specifications applied according to the characteristic of each medical device is needed due to a wide variety of usage and risk of medical devices, in which various technologies and materials are used, and thus an advanced expertise is required.

In addition, the business required by PAL becomes more complicated and increasing year by year, such as establishing, maintaining and updating the quality control system, maintaining the conformity to PAL in marketing, and conducting the post-marketing surveillance.

Japan RA service always tries positively to collect the information of the latest regulation and to acquire new medical technologies and knowledge, as the company entrusted with the outsourcing of these business, to answer your needs with daily effort.

 

Business Outline

  • Preparation for regulatory application
     
  • Writing of approval application
     
  • Clinical trial related business
     
  • Support for license application
     
  • Technical translation

Preparation for regulatory application

  • Survey on application classification and class category
  • Planning of application strategy
  • Listing of documents to be requested to manufacturer
  • Request of test implementation to outside public institution
  • Translation of the data to be attached (electrical safety test, strength test, biological safety test, literatures, etc.)
  • Validity evaluation of overseas documents and translation
  • Support for application consultation with reviewing authority
  • Creation of test result format
  • Survey on predicate medical devices, and etc.

Writing of approval application

  • Application writing for marketing approval / certification of medical devices
  • Application writing for partial change of marketing approval / certification of medical devices
  • Service related to reliability assurance of application
  • Response writing to the enquiries
  • Correspondence with overseas manufacturer
  • Other consulting services on approval application, and etc.

Clinical trial related business

  • SOP writing for clinical trial
  • Support for the in-house system establishment for clinical trial
  • Support for writing the clinical protocol, case report form, briefing paper for consent and informed consent form
  • Writing of investigator’s brochure and clinical trial notification
  • Document preparation for IRB discussion request
  • Maintenance of documents for GCP conformity inspection
  • Preparation of the patient list
  • Support for writing the clinical trial report
  • Support for failure report, etc.
  • Other consulting services on clinical trial, and etc.

Support for license application

  • Support for obtaining license for a certain type
  • Writing of SOP, quality standard code, product standard code, and etc.

Technical translation

  • Translation of English and Chinese

Past Experiences

Disposable Products

  • Intravascular catheter
  • Injection needle, Puncture needle
  • Guidewire
  • Endoscopic related instruments
  • Borer
  • Injection syringe
  • Breathing system
  • Sterilization filter / HME
  • Dental materials
  • Wound dressing, and etc.
    (Remarks) Sterilization method: EOG sterilization, Gamma sterilization

Medical Electrical Devices

  • Electrocardiograph
  • Exercise electrocardiograph
  • Bedside monitor
  • ECG analyzer
  • Electroencephalograph
  • Pulse oximeter
  • Ventilator
  • Low frequency therapy equipment
  • Electromyograph
  • Spinal cord stimulation device
  • Laser surgical equipment
  • Suction equipment
  • Infusion pump
  • Contrast media injector
  • Hyperbaric oxygen chamber
  • Radiotherapy planning system
  • Endoscope
  • Navigation system
  • Diagnostic X-ray system
  • Extracorporeal shock wave lithotrity device
  • Cardiac defibrillator
  • Myocardial ablation system
  • Polygraph
  • Heart-lung machine / Blood pump
  • CT
  • Ultrasound imaging system
  • MRI
  • Electric cautery, and etc.

Implant

  • Cardiac pacemaker
  • Implantable cardioverter-defibrillator (ICD)
  • Intravascular stent
  • Osteosynthesis equipment
  • Shunt valve
  • Dental implant
  • Artificial joint, and etc.

Number of Past Business

  2004 2005 2006 2007 2008 2009 2010 2011 2012
Consultation 26 16 20 28 25 21 19 16 18
Approval application  (without STED) 
97 33* 0 0 0 0 0 0 0
Notification of marketing bussiness 0 0 14 12 10 5 8 8 15
Approval application
(with STED)
12 3 15 13 12 16 15 16 18
Application writing for certification 0 3 5 7 12 7 8 12 18
Translation0 33 30 28 28 52 23 18 15 12



* This figure was calculated from January to March, since STED is required
   for all applications after April in 2005.

Corporate Information

Company name

Japan RA Service Co., Ltd.

Address

1-2 Higashi 2-chome Okegawa-shi, Saitama 363-0013 Japan
Tel: 048-775-3479
Fax: 048-775-3409

Corporate history

April 7, 1995 Establishment
March 1, 2001 Company split and name change

Capital fund

9.6 million yen

CEO

Masumi Shimada

Number of employees

6

For more information, please contact us to call

+81-48-775-3479 or +81-70-5360-1688
 


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