Our goals in China and India:

• Promoting our services for the integrated support of medical device registration in the Russian Federation at the markets of the People’s Republic of China and India. Searching for prospective customers in China and India who manufacture medical devices, including in vitro products (analyzers, reagent kits, etc.) and seek to enter the Russian market. Arranging the turnkey registration of their medical devices in the Russian Federation, including the issue of a final Registration Certificate. Setting up a permanent training and information center to provide consulting services related to registration of medical devices in the Russian Federation and the Eurasian Economic Community (EAEC), which includes Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia.

• Acting as an Authorized Representative for the Chinese and Indian medical product manufacturers in order to help them enter the Russian market. Arranging the localization of production in the Russian Federation (if Chinese manufacturers are interested in setting up production facilities in Russia).

• Selling medical devices manufactured in China in the Russian Federation. Acting as a distributor, and organizing the distribution of products for Chinese and Indian medical device manufacturers, including in vitro products, in the Russian Federation.

• Searching for manufacturers of electronic equipment in China and India in order to promote it in the Russian Federation. TsTB MOS LLC, a member of ELECTRONTEST Group, works to support the launch of this category of products at the Russian market, including setting up a joint venture production in the Russian Federation. Electrontest Group offers an integrated solution for registration of medical devices, both in the Russian Federation and the Eurasian Economic Union (EAEU).

The Group includes the following companies:

• MEDALIS LLC is a consulting company offering the turnkey registration of medical devices both in the Russian Federation and the EAEU. It prepares technical and operational documentation in accordance with regulatory requirements, decrees of the Government of the Russian Federation, orders of the Ministry of Health of the Russian Federation and the Federal Service for Surveillance in Healthcare (Roszdravnadzor), as well as resolutions of the Eurasian Economic Commission (EEC). Our experts have a vast experience of obtaining registration of medical devices from Roszdravnadzor. Experienced staff of MEDALIS will prepare any and all documents required in accordance with the Rules for State Registration of Medical Devices and the EAEU regulations. The proper quality of documents and lack of inaccurate information will ensure that the state registration process is completed successfully and as promptly as possible, which is our aim. We render professional assistance in the development, adjustment and preparation of all necessary documents for registration dossiers. The main of these include the following:

  • Application for state registration of the medical device;
  • Information about regulations for the medical device;
  • Manufacturer’s technical documentation for the medical device (an extract from the technical file or technical specifications; risk management file; manufacturer’s reports; qualification test reports);
  • Manufacturer’s operational documentation for the medical device;
  • Documents certifying the results of technical tests of the medical device;
  • Documents certifying the results of tests for metering tools pattern approval for the medical device;
  • Documents certifying the clinical efficacy and safety of medical devices.
  • Documents certifying the results of toxicity testing of the medical device;
  
  

  We guarantee that the testing required for the purposes of state registration will be conducted to the highest standard and test results will be obtained in accordance with all the requirements prescribed and within the clearly defined time frames. We monitor the entire testing process and check test results for regulatory compliance. An uncontested advantage is that ELECTRONTEST Group has proprietary testing laboratories that ensure promptness of the registration process and high quality of the result. These include the Testing Center of Electrontest LLC which carries out technical tests of all types of medical devices, including in vitro devices, and the Testing Laboratory of ElectrontestBio LLC which performs toxicity testing to assess biological safety of medical devices and medicinal products.

• Electrontest LLC is the Testing Center which comprises the Technical Device Testing Laboratory (TDTL) of Electrontest LLC accredited by the Federal Accreditation Service (Rosakkreditatsiya) to carry out technical tests of medical devices, and the Clinical Diagnostic Laboratory (CDL) of Electrontest LLC which holds a license for clinical diagnostic tests from Roszdravnadzor and is accredited in the EAEU to conduct clinical and laboratory testing of in vitro medical devices for the purposes of their registration in the EAEU. The CDL of Electrontest LLC closely cooperates with various clinics in Moscow to conduct its clinical trials and clinical and laboratory testing of medical devices. The Testing Center of Electrontest LLC was accredited by the ILAC, and thus can accept test reports (including for in vitro devices) to obtain the European CE product safety certification.

• ElectrontestBio LLC is a toxicity testing laboratory that tests medical devices and medicinal products for biological safety. The laboratory has the divisions for microbiological research, chemical and sanitary research, and toxicity studies with a vivarium.

• The Center for Technical Safety of Materials, Equipment and Complex Systems (TsTB MOS LLC) is a manufacturing company that designs and manufactures test equipment for technical testing of various categories of products, including medical devices.

• MAXMEDTECH LLC is a company originally set up to repair and maintain medical equipment. In 2003, the company also began importing equipment to Russia. Currently, Maxmedtech is a vendor and official dealer of many well-known medical equipment manufacturers. It offers only proven and high-quality equipment of such manufacturers as Philips, Toshiba, Pentax, Interacoustics, Maico, Technomedica, Innomed, Meditech, Fukuda Denshi, Cardioline, Heinemann, Bistos, Weinmann, Leisegang, SIUI, Mindray, EDAN, Emperor, Aloka, and many others. The company also has a proprietary service center and employs a team of engineers to maintain medical equipment.

All member companies of Electrontest Group are under common management and have a common system of communications based on their common final goal to ensure successful registration of medical devices in the Russian Federation and the Eurasian Economic Union.