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Single service for registration of medical products.

The first complex registration company is a company that provides services for the registration of medical devices, including the development of documents and testing.

  • international

    Our company is a member of the international association FBA EAC.

  • result

    We guarantee a refund if you do not receive the expected/planned result.

  • professionalism

    Professionalism of the company - more than 30 years of experience in registration of medical devices.

Why choose us:

  • 1

    Fair price

    With our company you can save up to 30% of your time and budget.

  • 2

    Quality assurance

    Our company works only with proven test centers.

  • 3

    Help with sample delivery

    We provide assistance in the delivery of test samples to Russia.

About Us

The first complex registration company is a company that provides services for the registration of medical devices, including the development of documents and testing. Our company was established in 1993 to provide medical device registration services.

Why choose us:

  • All activities of the company are absolutely transparent - a special application gives our clients the opportunity to monitor the status of all their projects in real time, set tasks, ask questions about projects, exchange documents
  • We have our own laboratory to carry out the necessary technical and clinical tests
  • Working with us is safe for our clients - all information transmitted to us is securely protected
  • Our clients are financially protected - the company's professional services in the field of consulting on the registration of medical devices are insured by leading Russian insurance companies
  • We have developed our own training program, according to which all our specialists undergo professional retraining
  • Our specialists regularly improve their skills and participate in forums and seminars organized by the Federal Service for Sanitary Supervision of Russia
  • Our company keeps growing and developing!
  • The online system provides mutual communication with clients 24 hours a day.
about

Our services

Our company performs a full range of work on the registration of medical devices.

  • I. Overview
  • II. Main process
  • III. List of technical documents
  • Medical device registration certificate is required for the sale and use of medical devices in Russia
  • 1. Preparation of technical documentation
  • 2. Notarization of documents
  • 3. Evaluation of technical documents
  • 4. Organization of delivery of test samples to Moscow
  • 5. Evaluation of the document, review, addition
  • 6. Submitting an application and getting approval
  • 7. Examination and review of documents (stage I)
  • 8. Clinical trials (defined by the product)
  • 9. Examination of documents (stage II)
  • 10. The Russian registration certificate of a medical device was received
  • 1. Power of attorney
  • 2. Application
  • 3. Manufacturer's details (exact company name in Chinese and English, address, contact person and contact information, etc., if the registered address is different from the actual production address, please check separately)
  • 4. Appropriate manufacturer's qualifications (valid business license, organization code certificate, tax registration certificate, trademark certificate, patent certificate, export license / certificate of free sale, etc.)
  • 5. Medical device CE certificate and EU declaration
  • 6. ISO13485 certificate (during the validity period)
  • 7. Product information (exact product name in English and Russian, model, spare parts list, customs code, etc.)
  • 8. Product brochures
  • 9. Product manual (in English or Russian, including the intended use of the product, requirements for use, requirements for disinfection and sterilization, etc.)
  • 10. Product drawings (circuit diagram, electrical drawing, packaging drawing)
  • 11. Map of product labels (in English or Russian)
  • 12. Product test report (functionality, toxicology, clinical report, CE test report, etc.)
  • 13. Risk analysis
  • 14. Others

Our clients:

Company name Product name
BMC Medical Co., Ltd Artificial lung ventilation apparatus
Nanjing Trust Garment Co., Ltd Insulating overalls
Zhongshan Yutian Apparel Co., Ltd Non-sterile insulating suit
Shenzhen Beacon display technology Co., Ltd Monitors
GE Medical Systems (China) Co., Ltd Ultrasound device
GE Vingmed Ultrasound AS Ultrasound device
Detex-Ohmeda, Inc. Anesthesia system
GE Medical Systems Information Technologies, Inc. ECG machine
Guangzhou Wanhe Plastic Materials Co.,Ltd breast implant
Yuyao Jiusheng Medical Instrument Factory breast implant
Foshan SOCO Precision lnstrument Co.,Ltd Dental tools
Xiamen AmonMed Biotechnology Co., Ltd Covid-19 Antigen Rapid Test Kit (Colloidal Gold) (Anterior Nasal Swab)
Jiangsu Hongxin Medical Technology Co., Ltd Urological catheters
Beijing ZONCI Technology Development Co., Ltd Automatic Blood Coagulation Analyzer HEMATITE
URIT Medical Electronic Co., Ltd 1. Automatic urine sediment analyzer UD-1320, complete with accessories;

2. Analyzer automatic urinary dry chemistry UC-1800 in the composition, with accessories;

3. Washing solution D16 for the Automatic Urine Sediment Analyzer UD-1320;

4. Washing solution (concentrate) D21N for analyzer of automatic urinary dry chemistry UC-1800;

5. Flow measurement solution S11 for automatic urine sediment analyzer UD-1320;

6. Urinalysis Test Strips for UC-1800 Automatic Urinary Dry Chemistry Analyzer;
«YANTAY ADDCARE BIO-TECH LIMITED COMPANY» Fully Automated ELISA Workstation: АDС ELISA 200, АDС ELISA 400
Allmed Medical Products Co., Ltd Medical gauze wipes, sterile Sterilux® ES/Sterilux EC
Chengdu Sani Medical Equipment Co.,Ltd Dental endomotor
CARLISLE MEDICAL TECHNOLOGIES, (DONGGUAN) CO., LTD Merlin 2 Pacemaker/Defibrillator Programming Device

Our contacts

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