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Specially know how to determine the classification of medical devices in china

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Specially know how to determine the classification of medical devices in china, Presented by Michael Petersen from CIRS China (www.cirs-md.com).

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Specially know how to determine the classification of medical devices in china

  1. 1. We are your local Regulatory Staffs Specially Know How to Determine the Classification of Medical Devices in China 上官福调|Michael Petersen senior consultant www.cirs-md.com email: michael@cirs-group.com
  2. 2. www.cirs-md.com Contents A. Overview of CFDA Regulations on Medical Devices Classification B. Practical Advice on How to Classify Your Medical Devices in China C. How to Handle When Classification of Your Devices Changed D. Easy Direction to Use CMDRD
  3. 3. www.cirs-md.com A. Overview of CFDA Regulations on Medical Devices Classification  Overview of CFDA classification regulations - Definition of medical device in China - Risk based classification - Read CFDA category code of medical devices - Read the CFDA registration license
  4. 4. www.cirs-md.com A.1 Definition of Medical Device in China Any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
  5. 5. www.cirs-md.com A.1 Definition of Medical Device in China  Diagnosis, prevention, monitoring, treatment or alleviation of disease;  Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;  Investigation, replacement or modification for anatomy or a physiological process;  Life support or maintenance;  Control of conception;  Offer information for medical or diagnosis purpose via inspecting the human samples. Updates of The Definition of Medical Devices
  6. 6. www.cirs-md.com 2000 version 2014 version any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives: 1. Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; 3. Investigation, replacement or modification for anatomy or a physiological process; 4. Control of conception. Any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives: 1. Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; 3. Investigation, replacement or modification for anatomy or a physiological process; 4. Life support or maintenance; 5. Control of conception; 6. Offer information for medical or diagnosis purpose via inspecting the human samples. Expand the definition of “Medical Device” A.1 Definition of Medical Device in China
  7. 7. www.cirs-md.com A.2 Risk Based Classification Risk Lower Higher Class I medical devices Medical devices with low risk, the safety and effectiveness of the device can be ensured through general controls. Class II medical devices Medical device with medium risk, strict controls are required to ensure the safety and effectiveness of the device. Class III medical devices Medical device with great risk, special controls are required to ensure the safety and effectiveness of the device.
  8. 8. www.cirs-md.com A.3 Read CFDA Category Code of Medical Devices MD Code Category Name Exampled Products 6801 Basic Surgical Operation Instruments hooked needle, vessel dilator, scalp clip system, dermal curette, dissecting forceps, dissector 6802 Microsurgical Operation Instruments micro-needle holders, micro-scissors, surgical rinsing needle , micro retractor 6803 Neurological Surgical Devices aneurysm clips, hand cranial drill, brain spatula, brain curette, nerve hook 6804 Ophthalmic Surgical Devices ophthalmic forceps, eye speculum, disposable ophthalmic surgical knife, vitreous cutter, chute blades 6805 ENT Surgical Instruments nose Scissors, rhino scope, nasal cavity retractor, ear probe, aural clamp 6806 Stomatological Surgical Operation Instruments gums separator, dental chisel, amalgam carrier, amalgam carver, nerve broach holders 6807 Thoracic And Cardiovascular Surgical Instruments thoracic haemostatic forceps, lung grasping forceps, mitral valve clip system accessories, rib retractor, 6808 Abdominal Surgical Operation Instruments kent retractors, extraction balloon, gastric banding surgery closer, intestinal clamp 6809 Urology Anorectal Surgical Operation Instruments bladder neck clamp, anoscope, urethral dilator, renal pedicle clamp, small knife in anorectal surgery, Nano circumcision device
  9. 9. A.3 Read CFDA Category Code of Medical Devices (continued) MD Code Category Name Exampled Products 6810 Orthopedic Surgery (Orthopedic) Surgical Instruments plaster scissors, bone saw, tibia cutter, bone holder forceps, skeletal traction pin 6812 Obstetrical And Gynecological Surgical Operation Instruments caesarean scissors, umbilical cord scissors, vaginal drag hook, intrauterine doctor blade 6813 Family Planning Operation Instruments uterine curette, vas deferens separation forceps, fixation forceps for deferens, deferens extraction plate (hook) 6815 Puncture Injection Equipment skin prick box, percutaneous puncture instrument, glass syringes, amniocentesis needle 6816 Burn & Plastic Surgical Operation Instruments dermatome, skin graft mesher, electric/pneumatic dermatome 6820 General Examination Equipment fetal stethoscope, brain percussion hammer, ophthalmic examination lamp, thermometer 6821 Medical electronic equipment body composition analyzer, hearing aid analyzers, audiometer, childbirth monitor, anesthetic index analyzer 6822 Medical Optical Equipment, Instruments And Endoscopic Equipment contrast sensitivity analyzer, endoscopic camera system, anesthesia video laryngoscope 6823 Medical Ultrasound Equipment And Related Equipment doppler ultrasound system, vascular flow meter system, ultrasound stethoscope, diagnostic ultrasound images 6824 Medical Laser Equipment helium-neon laser therapy machine, laser knife, assisted reproduction laser system, laser skin therapeutic apparatus, laser melting fat analyzer
  10. 10. A.3 Read CFDA Category Code of Medical Devices (continued) MD Code Category Name Exampled Products 6825 High-Frequency Medical Equipment surgery electrode, electric coagulation tweezers, full - face photo rejuvenation apparatus, microwave therapy unit 6826 Physiotherapy And Rehabilitation Equipment sleep aid device, automatic eye exercises meter, effervescent mouthwash, skin needle, anti-snoring device 6827 Traditional Chinese Medical Equipment vacuum tank, scrapping plate, three edged needle,, traditional chinese medical sweating detector 6828 Magnetic Resonance Equipment For Medical MRI system, MRI breast coil piercing retainer 6829 Ophthalmology Instruments and Appliances corneal topography, examination kerato scope used for corneal astigmatism, dry eye detector 6830 Medical X-Ray Equipment gastrointestinal X-ray equipment, X-ray machine, X-ray absorptiometry, X-ray photographic equipment, 6831 Module And Subsidiary Equipment For Medical X-Ray high-voltage generator, X-ray contrast agent injection device, general X-ray tube, electric photography flat bed, CCD imaging system 6832 High-Energy Rays Equipment For Medical radiotherapy simulator, multicavity balloon catheter device, medical electron linear accelerator 6833 Medical Radionuclide Equipment radiotherapy simulator, multicavity balloon catheter device,, X-ray stereotactic radio surgery system 6834 Protective Equipment And Fixtures For Medical Radiation microwave protection products, protection device like protective screen, ray protective chair, medical radiation guard supplies 6840 In Vitro Diagnostic Reagents, Clinical examination and analysis instrument sputum digestion, disinfection products, staining sealant, biosensor chip analyzer, blood gas analyzer electrode film
  11. 11. A.3 Read CFDA Category Code of Medical Devices (continued) MD Code Category Name Exampled Products 6841 Medical assay device and basic equipment tissue processor, slicer, automatic chip pusher stainer system, CO2 incubator, heatable forceps, fecal analysis workstation 6845 Extracorporeal circulation and blood processing equipment microthrombus filter, peritoneal dialysis tube, blood component separator, plasma separator, cell sorting beads 6846 Implant Materials And Artificial Organs human biological dressings, absorbable nerve regeneration tube, titanium mesh prosthesis, stent, silver clip 6854 Equipment And Appliance Used In Operating Rooms, Emergency Rooms, Clinics Room Utensils slip-type skin expander, smart infusion assistant, vacuum extractor, oxygen inhaler, anesthesia machine evaporator 6855 Equipment And Appliance For Department Of Stomatology teeth whitening pen, dental implant surgery guide board, dental drill, bone powder stocker, saliva suction head 6856 Equipment And Appliance For Ward Nursing ordinary sickbed, electric anti-bedsore mattresses, suction nozzle for hepatic abscess, manual operating table 6857 Equipment and appliance for disinfection and sterilization medical disinfectant package, microwave sterilizer, blood thermostat light box, cleaning and disinfection dryer 6858 Medical cold therapy, low temperature, cold storage equipment and appliance cryosurgical system, blood refrigerated container, cold spray, medical physics cooling device, liquid nitrogen storage system 6863 Dental material dental gold deposition solution, polishing paste, dental separating agent, caries indicator 6864 Medical Hygienic Materials And Dressings alcohol pads, iodine swab, elastic bandages, plaster bandages, carbon fiber dressing, periodontal dressing
  12. 12. www.cirs-md.com A.3 Read CFDA Category Code of Medical Devices (continued) MD Code Category Name Exampled Products 6865 Medical Suture Materials And Adhesives stainless steel sutures, silk line, pure gold sutures, catgut, human albumin medical absorbable sutures 6866 Medical polymer materials and products endoscopic irrigation tube, electrode catheter, suction bags, anus canal, canales ventriculi 6870 Software PACS, vibrating sound bridge conditioners database, ECG division information systems, glucose data analysis software 6877 Interventional Appliances PTA catheter, balloon catheter, balloon dilatation catheter, balloon pressurizer, intravascular angiography catheter Non-Medical Device ………..
  13. 13. www.cirs-md.com A.4 Read the CFDA Registration License ×1 stands for registration type(准、进、许): “准” used for domestic registration; “许” used for Formosa, HK and Macao registration; “进” used for imported registration. ××××2 stand for approved year; ×3 stands for classification leve: Class I/ II/ III; ××4 stands for classification code: from 6801 to 6877 ; ××××5 stands for the registered serial number. (国)食药监械(进)字2013 第3641234号 CFDA Imported Approval Year Classification Level Classification Code Registered Serial Number
  14. 14. www.cirs-md.com B. Practical Advice on How to Classify Your Medical Devices in China  Practical advice on your classification - Streamline the classification process - Class catalogue of medical devices in China - CFDA classification criteria - How to apply classification determination to NIFDC
  15. 15. www.cirs-md.com B.1 Streamline The Classification Process Streamline the classification process Class I Class II Class III Apply for Classification Determination to NIFDC Criteria for Medical Device Classification Classification Catalogue of Medical Devices in China Feel Free to Search CMDRD Very Soon!
  16. 16. How to Classify Your Medical Device Classification Catalogue Excluded from Catalogue Refer to Classification Criteria Apply for Classification Determination to NIFDC Determine Classification of Your Medical Device: Class Ⅰ/Ⅱ/Ⅲ Feel Free to Access CMDRD next
  17. 17. www.cirs-md.com B.2 Classification Catalogue of Medical Devices in China back
  18. 18. www.cirs-md.com B.3 CFDA Classification Criteria back
  19. 19. www.cirs-md.com Determining the category Inform of the results in classification information system New product: Technical advice Of classification Auditing by Medical supervision and management authority of CFDA Inform the results by publishing relevant documents Imported Medical Devices Submitting the application to Management centers of medical device standard B.4 How to Apply Classification Determination to NIFDC back
  20. 20. www.cirs-md.com C. How to Handle When Classification of Your Devices Changed  How to deal with classification change - A historic review of classification change of some medical devices - Useful advice when classification of your devices changed
  21. 21. www.cirs-md.com C.1 Historic Review of Classification Change of Some Medical Devices SARS period, the classification of infection control face mask was changed from Class I to Class II Nano bio-material based medical device was changed from Class II to Class III Intestinal anastomosis clip was changed from Class III to Class II Calcium hydroxide cataplasm was changed from Class II to Class III All sterile devices and sanitary materials those contain disinfectant were changed to at lease Class II 2003.05.23 2006.04.11 2007.07.08 2010.09.07 2014.09.15 Milestones for medical device classification change in China
  22. 22. www.cirs-md.com There are some devices deemed to be no longer managed as class I medical devices in China  Sterile cotton swab  Sanitary swab contains disinfectant, like ethyl alcohol, iodine tincture or iodine  Surgical instruments used with the endoscope  Orthopedic surgical instruments directly contacted with inter-vertebral space when used  Collective packing product contained higher control level medical devices  Determine the new classification of your devices  Check if it is complied with the new product mandatory standard.  Petition CFDA for classification determination via online application system.  Submit the update registration dossier to CFDA and obtain the new medical device registration certificate How to comply when classification changed? Some medical devices’ managing category changed C.1 Historic Review of Classification Change of Some Medical Devices (continued)
  23. 23. www.cirs-md.com C.2 Useful Advice When Classification of Your Devices Changed Classification change from higher level to lower level • Your CFDA license keep working during the validation. Classification change from Class I to Class II/III • Apply for the new CFDA license within 6 months • Conduct product testing in CFDA qualified laboratories • Conduct clinical trial in CFDA qualified hospitals if your device is not exempted from clinical trial • Supplement additional submission package Classification change from Class II to Class III • Apply for the new CFDA license within 6 months • Check if it is complied with the new product mandatory standards • Submit updated registration dossiers to CFDA Classification change to Non-medical device • Your cannot keep using your CFDA license • Apply for other license for your product as the new managing category
  24. 24. www.cirs-md.com D. Easy Direction to Use CMDRD  Easy direction to use CMDRD - What is CMDRD? - What can CMDRD do for you? - How to use CMDRD (live)?
  25. 25. www.cirs-md.com D.1 What is CMDRD? China Medical Device Regulatory Database - CMDRD provides a simple, easy-to-use interface for quick access to China medical device classifications, regulations, standards, guidelines and other important database.
  26. 26. www.cirs-md.com D.1 What is CMDRD?  MDCSS-Medical Devices Classification Search System  MDCS-Medical Devices Classification System  MDRGD-Medical Device Regulations and Guidance Database  MDSSS-Medical Devices Standards Search System  MDRSC-Medical Devices Regulatory Supporting Center  Classify your medical device  Define the technical requirement for your product  Determine the regulatory obligations  Tracking CFDA issues  Get the practical advice on regulatory compliance  Supported by professional RA specialist online  Removing language and cultural barrier Benefits from CMDRD:
  27. 27. www.cirs-md.com D.2 What Can CMDRD Do for You? MDCSS – medical devices classification search system enable you to determine the product name, classification name, classification codes, intended purpose, structure features and the managing category MDCS – medical devices classification system enables you to determine the managing category for your product by screening the factors of intended purpose, structural features, intended for use and use descriptions
  28. 28. www.cirs-md.com D.2 What Can CMDRD Do for You? MDCSS – medical device regulations and guidance database enable you to be well noted of following info:  What is your legal obligations under CFDA regulations  Practical know how to comply with CFDA regulations  The data requirements and application dossiers for overseas applicant should be prepared  The implementation timeline and the deadline  The background of the regulations (revision history) Expert suggestions for overseas applicant to acquire the relevant approval from CFDA
  29. 29. www.cirs-md.com D.2 What Can CMDRD Do for You? MDSSS – medical device standards search system enables you to search the relevant standards and technical guideline by standards number and name, and apply for the text from CIRS Medical Devices Regulatory Supporting Center (MDRSC)
  30. 30. www.cirs-md.com D.2 What Can CMDRD Do for You? MDRSC – medical device regulatory search system enables you to access us directly, you can acquire the practical advice on how to comply with the medical devices regulations in China and how to export your product into China, and to ensure efficient and effective integration of regulatory information in support of medical device entering into Chinese market
  31. 31. www.cirs-md.com D.3 How to Use CMDRD (live)? a) You can access CMDRD by scanning above QR (Quick Response) code, or b) You can access CMDRD by inputting: cmdrd.cirs-md.com, or c) You can access CMDRD by navigating: www.cirs-md.com .
  32. 32. www.cirs-md.com Thank You! Address: 11F,1# Building Dongguan High Tech Zone, 288# Qiuyi Road, Binjiang District, Hangzhou, Zhejiang, China, 310052 Tel: 0086 571 87206559 Fax: 0086 571 87206533 Email: Michael@cirs-group.com

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