Russian market access pdf


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Russian market access pdf

  1. 1. Flexible, FastTrack solutions from BSI Expertise and experience Helping you put the piece in the puzzle Russian Market Access Programme
  2. 2. Let our experience help and support you through the Russian medical devices registration process Three Unique reasons to let BSI help you achieve product registration in Russia Experience: We have a wealth of experience in helping medical device manufacturers achieve their product registration with the Russian Regulatory Authorities. Expertise: We have Russian speaking technical experts who can help you to ensure your product registration documentation is fully aligned with the requirements of the RRA. Market Access: At BSI we understand the importance for companies wishing to sell into new markets. Our Russian market access programme will help you to stay ahead of the competition. At BSI we fully understand the challenges that manufacturers face when looking to access new markets. In today’s world manufacturers need to increase their global footprint as markets become more and more competitive. The Russian registration programme has been designed to help manufacturers successfully navigate their route to receiving product registration in a timely manner. To achieve successful registration it is critical that you work with a market leader who fully understands the processes and procedures. The Russian medical device registration process is very complex and most of the documentation is not in English, discussions about your product registration are normally face to face in Russia with the authorities. Our in-house technical experts work closely with our Russian based authorised representatives to ensure the transferring of your product documentation into Russian is to the highest possible standard. Your completed Dossier will be hand delivered to the Federal Service for Control of Healthcare and Social Development (Roszdranadzor) for final review. If your submission has been successful you will receive your confirmation letter. When you choose BSI to support your business you know that you have the peace of mind in knowing you are working with a premium global agency as effectively demonstrated with its role as a Notified Body. From day one you will have fast access to experience and expertise giving you the peace of mind in knowing that every step taken is moving your business nearer to accessing a whole new market. Our goal is to assist you in making your registration as important to us as it is to you so that you can realise a faster return on your investment.
  3. 3. The fast route into the Russian market Step 1: Identify the procedure that is applicable to your product Step 3: BSI provides a formal Quotation to customer Step 5: BSI completes a full review of all documentation Step 7: BSI works with Russian business partner Step 9: Customer receives formal notification that their application has been successful Step 8: Russian business partner does final consolidation of file and hand delivers to Russian Ministry of Health Step 4: Customer signs quotation and returns to BSI Step 2: Complete a BSI Customer Information Form Step 6: BSI translate all the documentation into Russian Step 10: Registration certification is issued.
  4. 4. ©BSIGroupBSI/UK/1575/MD/0413/en/BLD BSI Group - Netherlands Adam Smith Building T.R.Malthustraat 3c Amsterdam 1066 JR The Netherlands T:7 +31 20 346 0780 F:7 +31 20 346 0781 E:7 BSI Group - EMEA Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP United Kingdom T:7 +44 845 080 9000 F:7 +44 1908 814920 E:7 BSI Group America Inc. 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 USA T: +1 800 862 4977/703 437 9000 F: +1 703 437 9001 E: BSI Group Canada Inc. 6205B Airport Rd, Suite 414 Mississauga,  ON  L4V 1E3 Canada T: +1 800 862 6752/416 620 9991 F: +1 416 620 9911 E: BSI Group Asia Pac BSI - Singapore 460 Alexandra Road # 08-01/01, PSA building Singapore 119963 T: +65 627 00777 F: +65 627 02777 E: Visit us online at: BSI Group - Germany BSI Group Deutschland GmbH Eastgate Hanauer Landstraße 115 60314 Frankfurt Germany T:7 +49 69 2222 89 200 F:7 +49 69 2222 89 300 E:7 The trademarks in this material (for example the BSI logo or the word “KITEMARK”) are registered and unregistered trademarks owned by The British Standards Institution in United Kingdom and certain other countries throughout the world. Global expertise Your partner in worldwide compliance: Call BSI today on +44 845 080 9000 or visit – to start your partnership Certification services ISO 13485 QMS Auditing CE marking Health Canada CMDCAS Japan PAL FDA 510k Third-Party Review Programme FDA Accredited Persons Inspections Australia EU CAB Hong Kong CAB Russian Registration Certification Taiwan TCP Training courses CE marking for AIMD, MDD and IVD ISO 13485 QMS Medical Devices Risk Management ISO 14971 CE marking Medical Devices with Software Compiling and Maintaining Technical Files and Design Dossiers Clinical Evaluation for Medical Devices Device - Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process Process Validation for the Medical Device industry Post Market Surveillance and Vigilance Medical Devices Utilizing Material of Animal Origin.