6 Steps to Global Markets
- 1. SIX STEPS to A t Access Global Gl b l Medical Device Markets October, 2013 Justin Heyl, Consulting Program Manager at Intertek Heyl Bhavesh Sheth, Consultant 1 www.intertek.com
- 2. Meet Our Presenter: Justin Heyl Justin Heyl is Intertek’s Consulting Program Manager. Leading Intertek’s medical device consulting team, Justin partners with startups as well as Top 10 companies th i throughout th i h t their development cycles to expedite market access on a global scale. 2 www.intertek.com
- 3. Meet Our Presenter: Bhavesh Sheth Bhavesh Sheth is Intertek’s lead consultant for FDA 510(k) submissions. With extensive knowledge of requirements and the applicability of various national and international standards for design, safety, performance, risk analysis, f t f i k l i biocompatibility, sterilization, and labeling of medical devices, Bhavesh s Bhavesh’s regulatory expertise will help you avoid project delays and meet your business goals. 3 www.intertek.com
- 4. An Extensive Global Network • Leading quality solutions provider • Origins back to 1885 g • Market Capitalisation > £5bn • 2012 Sales £2.0bn, EBITA £335m ( (16.3%) ) • 9.0% Average FY Organic Revenue growth 2002-12 More than 1,000 More than 100 laboratories and offices countries 36,000 , people 4 www.intertek.com
- 5. Where do you want to go? Russia China Japan India Brazil 5 www.intertek.com
- 6. Here’s how to get where you want to go. Six Steps to Global Markets 1.Regulatory Background 2.Product Assessment 3.Device Classification 4.In-Country Representation g q 5.Registration Requirements 6.Preparation & Submission 6 www.intertek.com
- 7. Country Profile: China • By 2015, Medtech Market Projected to be $11.4 billion vs. U.S. $160B vs. Europe $115B • • • • Medical Device Market $ billion $9 Annual per capita healthcare spend $432 (5.2% GDP) Per Capita spend on Medical Devices $12.6 Medtech Market Forecasted Growth 20% through 2018 • $120 Billion Healthcare stimulus initiated in 2009 has spurred investment in infrastructure, creating tremendous opportunity for manufacturers • 70% of high end medical devices are imported 7 www.intertek.com
- 8. Country: China Step 1 p 8 Regulatory Background www.intertek.com
- 9. Step 1: Regulatory Background The China Food and Drug Administration (CFDA) was founded g ( ) on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration. It i responsible for supervision and administration of medical is ibl f i i d d i i t ti f di l devices in China. 9 www.intertek.com
- 10. Country: China Step 2 p 10 Product Assessment www.intertek.com
- 11. Step 2: Product Assessment "Medical devices" - instruments, equipment, tools, materials , q p , , and other objects, including the software, that are designed to be used on the human body. 1.Prevention, diagnosis, treatment, monitoring or remission of diseases 2. Diagnosis, t t 2 Di i treatment, monitoring, remission or compensation t it i i i ti of injury or physical disability 3.Research, 3 Research replacement or adjustment of anatomical or physiological process 4. 4 Control of pregnancy Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html 11 www.intertek.com
- 12. Country: China Step 3 p 12 Device Classification www.intertek.com
- 13. Step 3: Device Classification Class I - Devices for which safety and effectiveness can be ensured y through routine administration (products such as rehabilitation techniques, disinfecting devices and apparatus) Class II - Devices for which further control is required to ensure their safety and effectiveness Class III – Hi h i k d i Cl High-risk devices such as th h those implanted into the human body, or used for life support or sustenance; or the ones that pose potential risk to the human body (products such as implanted artificial internal organs and infant care devices) The classification system is i il t i similar to EU and U.S. dUS in that there are 3 device classes. However, a Class II device in the US or Class IIa/IIb device in the EU may be classified as Class III in China. Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html 13 www.intertek.com
- 14. Country: China Step 4 p 14 In-Country In Country Representation www.intertek.com
- 15. Step 4: In-country Representation Appoint a "Legal Agent and After Sales Agent" to co-ordinate pp g g g CFDA device registration. • Agents must be legal residents of China or maintain local business presences in China. • Legal Agent interacts with the CFDA during the device registration process and assists in obtaining registration renewal every four years • After Sales Agent is responsible for reporting all incidents related to the device to Chinese authorities following registration and commercialization of th d i i Chi i li ti f the device in China. 15 www.intertek.com
- 17. Step 5: Registration Requirements P Prepare and submit an application t CFDA f an I d b it li ti to for Import M di l D i t Medical Device Registration Certificate (IMDRC). Proof of registration in country of origin is required required. 17 This i diff Thi is different t compared to U.S and EU, where device approvals and registration are strictly g y based on the evaluation carried out by FDA or Notified Bodies. www.intertek.com
- 18. Step 5: Registration Requirements Submit the device to CFDA for testing. Testing is carried out by the CFDA g g y Medical Device Quality Supervision and Inspection Center. Clinical trials conducted in China could be required for devices that do not have regulatory approval in another country, and for high-risk devices. Except for new implant products and in-vitro reagents, foreign clinical data d t are mostly accepted and l tl t d d local i l investigation could b exempted i ti ti ld be t d in most circumstances. 18 www.intertek.com
- 19. Step 5: Registration Requirements China Compulsory Certification ( p y (CCC) is applicable to some medical ) pp devices with electrical components for safety conformity. If the device requires CCC Mark Certification, it must be obtained through testing the device in labs in China. An on-site audit of the legal manufacturer is also required. 19 www.intertek.com
- 20. Country: China Step 6 p 20 Preparation & Submission www.intertek.com
- 21. Step 6: Preparation & Submission Prepare Chinese Registration Standard dossier, including testing results, p g , g g , and submit to CFDA for approval. Foreign manufacturers must submit quality system certificates – ISO 13485 or show compliance with U.S. FDA Quality System Regulations. These are adequate to meet CFDA quality management system requirements 21 www.intertek.com
- 22. Step 6: Preparation & Submission CFDA reviews the application and issues IMDRC certificate, which is pp , valid for 4 years. Re-Registration is necessary in cases such as: • • • • • Manufacturer change Manufacturing site change Product name, model or components change Indications for use change Chinese registration standard (YZB) change Timeline: Entire process can generally take up to 12 months (class I device), 18 months (class II device) and about 36 months (class III device). 22 www.intertek.com
- 23. Country Profile: Brazil • Medical device market valued at nearly $5.9 billion. • Population g p growing at .9% annually g y • • • • • 6.7% of population 65 or older Per capita health care expenditure $1,121 Total T t l expenditure on health as a % of GDP 8 9% dit h lth f GDP: 8.9% Total population: 199,000,000 Medical device imports $2.8bn in 2012. 23 www.intertek.com
- 24. Country: Brazil Step 1 p 24 Regulatory Background www.intertek.com
- 25. Step 1: Regulatory Background Medical devices in Brazil are regulated by the National Health g y Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) 25 www.intertek.com
- 26. Country: Brazil Step 2 p 26 Product Assessment www.intertek.com
- 27. Step 2: Product Assessment Per Annex I of Brazilian Resolution RDC 185/2001; a medical ; device is defined as follows: Product for use in health, such as equipment, apparatus, material, article or system of use in health or implementing medical, dental or laboratory, for prevention, diagnosis, treatment, rehabilitation or contraception, and not using pharmacological, immune or metabolic means to perform their main function to humans, may however be assisted in his duties by such means. 27 www.intertek.com
- 28. Country: Brazil Step 3 p 28 Device Classification www.intertek.com
- 29. Step 3: Device Classification Device Classification System: y • • • • Class I Class II Class III Class IV Class I and II i l d l Cl d include low and medium risk d di i k devices. Class III and IV include higherrisk devices 29 4 d i classes means the device l th classification system is slightly different from U.S. FDA However, Brazilian Resolution RDC 185/01 is designed similarly to the European Medical Device Directive (93/42/EEC) (93/42/EEC). Classes I, II, III and IV in Brazil are similar to Classes I, IIa, IIb and III in the European Union www.intertek.com
- 30. Country: Brazil Step 4 p 30 In-Country In Country Representation www.intertek.com
- 31. Step 4: In-Country Representation Appoint a company that holds a Company pp p y p y Working Allowance permit from ANVISA as the Brazil Registration Holder (BRH). Similar to EU - Companies without a location in Europe must appoint an Authorized Representative to act on their behalf In case of U.S., foreign manufacturers must appoint “US Agent” and the company and device should be registered. No certificate is issued by FDA but the company is subject to random FDA inspections for QSR compliance. 31 www.intertek.com
- 33. Step 5: Registration Requirements It is mandatory to register all medical devices listed in RDC No. y g 185, except those products referred on items 2, 3 and 12 of Part 3 of this regulation. Prepare Technical File that includes information on the device. Obtain Certificate of Free Sale (CFS) or device registration certificate proving home-country approval - OR – The Registration requirements are similar to EU and U.S. in that all devices have to be registered. Demonstrate evidence of registration in two other markets and justify why the device does not have home-country approval. home country approval 33 www.intertek.com
- 34. Step 5: Registration Requirements Certain devices require INMETRO Certification, including medical q , g devices sold in Brazil that fall under the scope of the following standards: • NBR IEC 60601 series • NBR ISO 6875:1998: Dental patient chair • NBR ISO 7785-2:2004: Dental handpieces – Part 2: Straight and g g geared angle handpieces g p • NBR ISO 9919:1997: Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use • NBR ISO 11195 2000 G mixers f medical use – 11195:2000: Gas i for di l Stand-alone gas mixers This process is quite similar to EU and U.S. FDA's test data evaluation and policy of accepting test reports • NBR ISO 8835-2:2010: Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems 34 www.intertek.com
- 35. Country: Brazil Step 6 p 35 Preparation & Submission www.intertek.com
- 36. Step 6: Preparation & Submission Submit the registration application and Technical File to ANVISA g pp through BRH. ANVISA reviews registration application. High-risk and innovative devices must meet g ANVISA clinical trial requirements. ANVISA usually accepts clinical trial results previously conducted in other markets as adequate to meet such requirements. 36 Technical files required by ANVISA resemble documents required by the U.S. FDA. Applicants that have already prepared Technical Files for CE Marking or U.S. FDA 510(k) submissions may usually reuse similar information to prepare their Brazilian Technical Files. www.intertek.com
- 37. Step 6: Preparation & Submission Once approved, ANVISA will p pp , publish registration number in the Diário g Oficial da União (DOU). Note: Both ANVISA device registrations and INMETRO certifications must be renewed every five years 37 www.intertek.com
- 38. Country Profile: Russia • 73% share of healthcare market supplied by imports • 143 million population • $6B is the value of the Russian market for medical equipment and supplies • $42 per capita healthcare expenditure Source: U.S. Commercial Service, ReporterLinker 38 www.intertek.com
- 39. Country: Russia Step 1 p 39 Regulatory Background www.intertek.com
- 40. Step 1: Regulatory Background Roszdravnadzor (Federal Service for Control of Healthcare and ( Social Development in the Russian Federation) oversees all domestic and imported medical devices in Russia. 40 www.intertek.com
- 41. Country: Russia Step 2 p 41 Product Assessment www.intertek.com
- 42. Step 2: Product Assessment Scope: p Medical products designed for medical application in the territory of the Russian Federation which are designed for: - preventive treatment, diagnostics (in vitro), sickness treatment, after-care treatment, medical procedures, medical research, replacement and modification of parts of human body tissues, organs, organs recovery or compensation of disrupted or lost physiological functions, impregnation control; - production of effect on human organism so that their designated purpose is not implemented through chemical, pharmacological, immunological or metabolic interaction with human organism, but of which effect can be supported by such means. 42 www.intertek.com
- 43. Country: Russia Step 3 p 43 Device Classification www.intertek.com
- 44. Step 3: Device Classification Confirm classification of your device using Roszdravnadzor Order No. y g 735 and Rosstandart 51609-2000. Define the type of the medical device according to Decree No. 4n Class I – low-risk Class IIa – medium risk Class IIb – increased risk Class III – high-risk Search for equivalent medical devices already approved for sale in the Russian Federation. 44 This classification system is equivalent to that of EU and comparable to that of U.S. FDA. This is similar to the U.S. FDA 510(k) or Premarket Notification wherein substantial equivalence is to be claimed to previously cleared device (predicate device) www.intertek.com
- 45. Country: Russia Step 4 p 45 In-Country In Country Representation www.intertek.com
- 46. Step 4: In-Country Representation Appoint an Authorized Regulatory representative to co-ordinate the pp g y p registration process in Russia Only needed for devices classified as Class IIa IIb and III. For Class I devices, skip to Step 5. Similar to EU - Companies without a location in Europe must appoint an Authorized Representative to act on their behalf Difference (w.r.t U.S.) - If located outside the U.S., an “US Agent” must be appointed and the company and device should be registered. No certificate is issued by FDA but company is subject to random FDA inspections for QSR compliance. 46 www.intertek.com
- 48. Step 5: Registration Requirements Meet with officials to determine the testing g requirements for the device Submit a application for permission to import testing samples Conduct testing at government authorized testing and medical centers within R di l t ithi Russia i Receive results of testing and medical reports Apply for Regulatory Approval 48 This process is quite p q different compared to U.S. regulatory processes, where most Class I devices are exempt from PreMarket Notifications, most Class II and some Class III devices are subject to FDA 510(k); and most Class III devices are subject to PMA Russia's process is also different from EU; where a Technical File is typically needed for all device classes. www.intertek.com
- 49. Step 5: Registration Requirements Testing must be p g performed by local expertise y p centers and hospitals and the results must be included in the registration dossier. All applicable quality, safety and efficacy testing should be performed at Authorized Expertise Centers and Hospitals in Russia. 49 The testing requirements g q differ from EU and U.S., where testing to harmonized standards is generally accepted. So, the biggest hurdle for foreign manufacturers seeking device registration / approval in Russia is that it relies on a system of product testing as a tool for determining safety and efficacy. Such testing is also required for products that already possess CE marking, U.S. Food and Drug Administration 510(k) clearance or other national approval. www.intertek.com
- 50. Country: Russia Step 6 p 50 Preparation & Submission www.intertek.com
- 51. Step 6: Preparation & Submission Prepare a Registration Dossier that includes all technical details p g about your device, including testing results. Proof of home country approval must also be obtained using a CFS (Certificate of Free Sale) or CFG (Certificate to Foreign Government). Submit dossier and CFS or CFG to Roszdravnadzor. **All technical doc ments m st be s bmitted in documents must submitted Russian. 51 The requirement to have testing requirements conducted in Russia is stringent compared to U.S. FDA and EU Regulatory approval process www.intertek.com
- 52. Step 6: Preparation & Submission If the dossier is approved, Roszdravnadzor issues a Registration pp , g Certificate. To clear medical devices through Russian Customs, products must have one or both of the following certificates (which can only be issued after the Registration Certificate has been obtained): • S it Sanitary-Epidemiological C E id i l i l Conclusion (H i l i (Hygiene C tifi t ) Certificate) • GOST-R Quality Certificate Apply for a Declaration of Conformity (DoC) certificate 52 www.intertek.com
- 53. Country Profile: India • 1.26 billion population • 1.6% annual population g p p growth rate • 400 million middle income consumers in India • $35 billion - value of India’s healthcare market in 2011 • $2.7 billion - value of India’s medical device market in 2011 de ice • 15.6% Growth of India’s medical device market Source: U.S. Commercial Service, ReporterLinker 53 www.intertek.com
- 54. Country: India Step 1 p 54 Regulatory Background www.intertek.com
- 55. Step 1: Regulatory Background Import, manufacture, sale and distribution of medical devices are p , , regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. 55 www.intertek.com
- 56. Country: India Step 2 p 56 Product Assessment www.intertek.com
- 57. Step 2: Product Assessment Instruments, equipment, tools, materials and other objects, , q p , , j , including the software attached to them, that are designed to be used either independently or in combination on human body. 1.Prevention, diagnosis, treatment, monitoring or remission of diseases 2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability 3.Research, replacement or adjustment of anatomical or j physiological process 4. Control of pregnancy Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html 57 www.intertek.com
- 58. Country: India Step 3 p 58 Device Classification www.intertek.com
- 59. Step 3: Device Classification Identify if the device is in the list of "Notified Medical Devices" or y IVD's that require medical device Registration in India Note: In case of an IVD that is not on the list of regulated products, skip to Step 5 List of Notified Medical Devices: http://cdsco.nic.in/List%20of%20Notified%20Medical%20devices.pdf p p 59 www.intertek.com
- 60. Country: India Step 4 p 60 In-Country In Country Representation www.intertek.com
- 61. Step 4 In-Country Representation If the device is regulated, an India Authorized Agent should be g , g appointed to interact with CDSCO. Appoint an agent responsible for pre-certification and post-market surveillance inquiries. The authorized agent must maintain a drug wholesale license and be a resident of India OR maintain a place of b i id t f I di i t i l f business th there. 61 www.intertek.com
- 63. Step 5: Registration Requirements Only notified medical devices are regulated in India. The y g following medical devices are notified under the Drugs and Cosmetics Act. • Catheters, hear valves, cardiac stents, etc. For import of medical devices, the manufacturing site and products are required t b registered. d t i d to be i t d Guidelines and FAQ on Registration and Import of Medical Devices in India http://cdsco.nic.in/FAQIMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf 63 www.intertek.com
- 64. Country: India Step 6 p 64 Preparation & Submission www.intertek.com
- 65. Step 6: Preparation & Submission File your application for device registration ( y pp g (Form 41) ) Identify distributor in India and file application for Import license (Form 10) 65 www.intertek.com
- 66. Country Profile: Japan $29.8 billion Medical Device Market in 2013 g Second Largest Medical Device Market behind the U.S. Growth rate 2.5% through 2018 p ; p p Population 127.2 Million; 10th most populated country in the world Aging population with 23% 65 or older p p $3,958, , Per capita healthcare expenditure is $ , 8.5% GDP 66 www.intertek.com
- 67. Country: Japan Step 1 p 67 Regulatory Background www.intertek.com
- 68. Step 1: Regulatory Background Pharmaceuticals and Medical Devices Agency ( g y (PMDA) ) Pharmaceutical Affairs Law (PAL) PMDA is the Japanese regulatory agency working together with the Ministry of Health, Labor and Welfare to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. PAL covers regulations on pharmaceuticals, medical devices and cosmetics. 68 www.intertek.com
- 69. Country: Japan Step 2 p 69 Product Assessment www.intertek.com
- 70. Country: Japan Step 3 p 70 Device Classification www.intertek.com
- 71. Step 3: Device Classification Determine device classification according to Japanese PAL g p and JMDN codes. Class I - General Medical Devices Potential risk is almost insignificant in case of malfunction or side effect. Examples: scalpel, X-Ray film, etc. Class II - Specified Controlled Medical Devices Class II - Controlled Medical Devices Having potential risk in case of malfunction or side effect. Examples: MRI, electronic sphygmomanometers, etc. Class III - Highly Controlled Medical Devices Class IV - Highly Controlled Medical Devices Potential risk is significant in case of malfunction or side effect. g Examples: Dialyzer, pacemaker, stent, etc. 71 The classification system is significantly t i i ifi tl different when compared to U.S. and EU where devices are classified into Class I, , II and III www.intertek.com
- 72. Country: Japan Step 4 p 72 In-Country In Country Representation www.intertek.com
- 73. Step 4: In-country Representation Appoint Marketing Authorization Holder ( pp g (MAH or D-MAH) to ) manage and control the device registration in Japan. MAH and D-MAH Requirements • Must be based in Japan • Must be formally licensed by the prefecture of residence • Must employ at least three staff members: general manager, p y g g , quality manager and safety manager • Must implement GQP and GVP systems 73 The MAH and D-MAH has much more legal, logistic and regulatory responsibility compared to European Authorized Representative or an U.S. FDA Agent. www.intertek.com
- 75. Step 5: Registration Requirements To market medical devices in Japan, the MAH must register the p , g device through the following procedures. • Pre-market Submission (Todokede) • Pre-market Certification (Ninsho) • Pre-market Approval (Shonin) 75 www.intertek.com
- 76. Country: Japan Step 6 p 76 Preparation & Submission www.intertek.com
- 77. Step 6: Preparation & Submission Class I - General Medical Devices •Submit Pre-Market Submission to PMDA. •Self-declaration with no assessment or certificate issued by PMDA 77 www.intertek.com
- 78. Step 6: Preparation & Submission Class II - Specified Controlled Medical Devices p •Submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications. •Involves QMS audit and certificate issuance by RCB. The Pre-market Certification (Ninsho) is quite similar to European CE Marking using a Notified Body. Each Specified Controlled Medical Device must apply internationally harmonized standards as is the case with CE Marking 78 www.intertek.com
- 79. Step 6: Preparation & Submission Class II - Controlled Medical Devices Class III - Highly Controlled Medical Devices Class IV - Highly Controlled Medical Devices •Prepare Pre-Market Approval application as well as registration dossier in Summary Technical Document (STED) f format. S b it d t Submit documents t PMDA t to PMDA. •Involves QMS audit by PMDA. On-site audits required for y new devices, as well as Class IV devices and those requiring clinical investigations. 79 www.intertek.com
- 80. And more… • We have the expertise and global resources to get you exactly where you need to be – wherever you want to go. 80 www.intertek.com
- 81. Want More? Download the audio recording to accompany these slides www.intertek.com/medical/events/gma-webinar-2013 i t t k / di l/ t / bi 2013 If you h have questions about a specific device that you are ti b t ifi d i th t looking to bring to new markets, contact us directly. icenter@intertek.com 81 1-800-WORLDLAB www.intertek.com