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Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
Regulatory Strategies for Medical Device Companies to Succeed in Asia
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Regulatory Strategies for Medical Device Companies to Succeed in Asia

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This whitepaper provides an overview of strategies for medical device companies to succeed in Asia. Included is key market strategy information on China, Singapore, India, and Hong Kong. Also included …

This whitepaper provides an overview of strategies for medical device companies to succeed in Asia. Included is key market strategy information on China, Singapore, India, and Hong Kong. Also included is information on regulations, government regulatory bodies, device classification, product standard and type testing, product registration requirements and clinical trials.

For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.

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  • 1. Regulatory Strategies for Medical Device Companies to Succeed in Asia Pacific Bridge Medical 2013 White Paper www.pacificbridgemedical.com
  • 2. Regulatory Strategies for Medical Device Companies to Succeed in Asia Pacific Bridge Medical 2013 White Paper Copyright © 2013 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.
  • 3. Map of Asia Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 3
  • 4. China Medical Device Regulations Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 4
  • 5. China: Geography Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 5
  • 6. China: Medical Device Regulatory Authorities ❖ State Food & Drug Administration (SDFA) ♦ Founded in 1998. ♦ Equivalent to the U.S. FDA. ♦ Responsible for medical devices, drugs, and healthcare services. ♦ Headquarters is located in Beijing, with offices in each province also. ❖ General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) ♦ Conducts mandatory safety registration, certification, and inspection for certain devices. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 6
  • 7. SFDA: Medical Device Department Department of Medical Device Supervision Division of General Affairs Direct Affiliation Division I of Registration Division II of Registration Division of Manufacturing & Distribution Supervision Division of Research & Reevaluation Center of Medical Device Evaluation (CMDE) Division of Medical Device Provincial FDA Indirect Affiliation Certified Test Centers in Key Provinces Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 7
  • 8. Medical Device Classification ❖ Device Classification is the basis for determining regulatory requirements: ♦ Class I – Those which safety and effectiveness can be ensured through routine administration. ♦ Class II – Those which further control is required to ensure their safety and effectiveness. ♦ Class III – Those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 8
  • 9. New Class II & III that do NOT require clinical trials Product Registration Process Normal Timeline 1. Chinese Specification Drafting Dossier Preparation & Specification Drafting Depends on the Company and Product 6 Months Sample Testing 5 working days Filing to SFDA 90 working days 10 working days 2. Sample Testing 3. SFDA preliminary review & issues acceptance notice 4. CMDE review No 5. SFDA final approval CMDE Review Yes Approximate Total 12-18 months Copyright © 2013 Pacific Bridge Medical SFDA Final Approval | www.pacificbridgemedical.com 9
  • 10. Product Standard and Type Testing ❖ The Product Standard is the most important part of the registration: ♦ Because the product standard is not reviewed by the CMDE before testing, sample testing is done on the company’s product standard. ♦ If the testing result is deemed unsatisfactory, the CMDE/SFDA may request the company to revise the product standard and re-test.. ♦ Also, the SFDA will refer to the product standard to determine if different models can be registered under one import device license. ❖ In almost all situations, the SFDA will request samples for type testing. ❖ The testing centers will use the Product Standard to determine what tests to conduct. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 10
  • 11. Registration Requirements for Dossier ❖ Total 13 items of documents must be collected and submitted to the SFDA. ❖ Three parts of these 13 items: ♦ Legal Documents (9). ♦ Technical Documents (3). ♦ Testing report issued by SFDA certified testing center (if applicable). ❖ Documents must be in both Chinese and English. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 11
  • 12. Clinical Trials ❖ Clinical trial is required for medical devices when: ♦ New Class II & III medical device, which has not been approved anywhere in the world. ♦ Some Class III implant products. It is the first medical device product of the foreign company applying for registration in China, and this product has already been approved in the foreign country. ♦ Regulations for more clinical trials in China may be coming Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 12
  • 13. Singapore Medical Device Regulations Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 13
  • 14. Singapore: Demographics ❖ Population: 4.7 million ❖ Life expectancy: 82 years ❖ Major ethnic groups ♦ 77% Chinese ♦ 14% Malay ♦ 8% Indian ❖ Language ♦ Four official languages: Mandarin Chinese, English, Malay, and Tamil Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 14
  • 15. Singapore: Medical Device Regulatory Authorities ❖ Health Sciences Authority ( HSA ) ♦ www.hsa.gov.sg ❖ Centre for Medical Device Regulation ( CMDR ) Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 15
  • 16. Medical Device Regulatory Framework: Overview ❖ Registration of Products ♦ Medical devices must be registered with HSA before it can be supplied in Singapore ❖ Supply/Distribution Chain Control ❖ Post-marketing activity ♦ Advertising & promotion ♦ Recalls Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 16
  • 17. Medical Device Regulatory FrameworkClassification of General Medical Devices Class Risk Level Device Examples A Low Risk Surgical retractors / tongue depressors B Low-moderate Risk Hypodermic Needles / suction equipment C Moderate-high Risk Lung ventilator / bone fixation plate D High Risk Heart valves / implantable defibrillator Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 17
  • 18. Submission Routes for Class B, C, and D Medical Devices Abridged Submission ❖ ONLY for medical device already registered or approved in two of the following reference agencies: USA, Japan, EU, Canada, Australia Full Evaluation ❖ For all products not approved in two of the reference agencies Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 18
  • 19. Product Registration: Class B, C, and D Medical Devices (Full Evaluation) Identify that the product is a medical device Pre-Submission Consultation Pre-submission Consultation Regulatory Decision Submission of Device Dossier Submission of Device Dossier Screening of Device Dossier Acceptance of Device Dossier Evaluation by HSA Evaluation Decision Regulatory Decision Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 19
  • 20. HSA Product Registration Requirements: Medical Device Dossier Preparation ❖ Medical device product registration in Singapore uses the Association of Southeast Asian Nations (ASEAN) Common Submission Dossier Template (CSDT) ❖ The CSDT dossier must: ♦ Be prepared in English ♦ Have as Annexes copies of labeling, Certificates and Reports that are referenced within the CSDT submission ♦ Be signed off by the Product Owner for all Reports ❖ Sample components of the CSDT device dossier: ♦ Description of the medical device and its features ♦ Intended use, and indications ♦ Instruction of use Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 20
  • 21. India Medical Device Regulations Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 21
  • 22. Map of India Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 22
  • 23. HSA Product Registration Requirements: Medical Device Dossier Preparation ❖ There is no single national health insurance system; most people have no insurance. ❖ What exists is a number of schemes of free/ concessional treatments and insurance, mainly for hospitalization. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 23
  • 24. India’s Medical Device Market ❖ Market size : US$3.5 billion ❖ Per capita spending : US$2.50 ❖ Imports : 70% ❖ Recent annual growth rate : 12% ❖ Projected growth rate up to 2015 : 12 – 16% Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 24
  • 25. India Medical Device Regulation ❖ In India, the manufacturing, import, sale and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA). ❖ Drug Controller General of India (DCGI): ♦ DCGI is the key official in the Central Drug Standards Control Organization (CDSCO) Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 25
  • 26. CDSCOMedical Device & Diagnostic Division Organizational Structure Drugs Controller General of India (DCGI) Deputy Drugs Controller (India) Assistant Drugs Controller (India) Medical Device Division Drug Inspectors Diagnostic Division Technical Data Associates Copyright © 2013 Pacific Bridge Medical | Drug Inspectors Technical Data Associates www.pacificbridgemedical.com 26
  • 27. India Medical Device Regulators ❖ Functions of DCGI: ♦ Approval of manufacturing certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices and new drugs. ♦ Currently, only 40-50 medical devices require registration Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 27
  • 28. Product Registration Process ❖ Companies must register regulated medical devices with the CDSCO before they can be introduced into the Indian market. ❖ The product registration of medical devices can take between 6 and 18 months if there are no clinical trials. ❖ For registration of new medical devices, prior approval from the DCGI is required before the registration can be applied for. ❖ After receipt of application with fees, evaluation begins. ❖ DCGI may require clinical testing in India or abroad. ❖ DCGI may visit the manufacturing premises during the process Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 28
  • 29. Working Towards an Official Definition for Medical Devices ❖ The CDSCO released a draft document, Schedule M-III, which contains proposed official definitions for various types of medical devices in India. ❖ A four level medical device risk classification scheme (Classes A (lowest risk) to D (highest risk)) was also outlined in the new proposed draft Schedule M-III. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 29
  • 30. Proposed Classification for Medical Devices ❖ The draft Schedule M-III also has a risk classification for medical devices, according to their intended use. ❖ The risk classification is divided into Classes A,B, C and D. Class Risk Level Device Examples A Low Risk Thermometers / tongue depressors B Low-moderate Risk Hypodermic Needles / suction equipment C Moderate-high Risk Lung ventilator / bone fixation plate D High Risk Heart valves / implantable defibrillator Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 30
  • 31. Proposed Medical Devices Regulation Bill (MDRB) ❖ If enacted, the Medical Device Regulation Act (2006) will govern all medical devices throughout India. ❖ If enacted, the Act will establish the MDRA as the regulatory and enforcement body for medical devices. ♦ The MDRA is expected to be headquartered in New Delhi. There may also be other regional offices established in India. ♦ The CEO of the MDRA and other members of the organization shall be appointed by the Central Government. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 31
  • 32. Obtaining Import License ❖ The importer can apply for an import license from the DCGI. ❖ The following documents are required for submission for Import License (Form 10) of medical devices in India: ♦ Covering Letter ♦ Authorization Letter ♦ Completed Form 8 and Form 9 ♦ Wholesale License ♦ Additional Documents Required Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 32
  • 33. Hong Kong Medical Device Regulations Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 33
  • 34. Some Facts about Hong Kong ❖ Located at China’s south coast at Pearl River Delta ❖ Area of 1,104 km2 ❖ Consisted of Hong Kong Island, Kowloon Peninsula and the New Territories ❖ Population at end 2010 is 7.1 million Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 34
  • 35. Department of Health (DH) ❖ Community Health and health policies/strategies such as SARS, Bird Flu, Scarlet Fever and Legionnaires Disease controls ❖ Community health program, vaccine schemes and education ❖ The Regulator for pharmaceuticals and drugs, radioactive substances and medical devices ❖ Licensing for medical professionals, Chinese herbal doctors ❖ Licensing for 12 private hospitals ❖ Consists of ♦ Centre for Health Protection ♦ Pharmaceuticals and Drug Control Office ♦ Radiation Health Unit ♦ Medical Device Control Office Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 35
  • 36. Hospital Authority (HA) ❖ Consists of 7 Clusters: HK East Cluster, HK West Cluster, Kowloon East Cluster, Kowloon Central Cluster, Kowloon West Cluster, New Territories East Cluster and New Territories West Cluster ❖ Major Acute Hospitals: 1. Pamela Youde Nethersole Eastern Hospital (PYNEH) 2. Queen Mary Hospital (QMH) 3. Queen Elizabeth Hospital (QEH) 4. Princess Margaret Hospital (PMH) 5. United Christian Hospital (UCH) 6. Prince of Wales Hospital (PWH) 7. Tuen Mun Hospital (TMH) Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 36
  • 37. What’s More – It’s Business !! (5) Major procurement in HK comes from Hospital Authority. They are already referring to the voluntary list as a preference for procurement for capital equipment and major purchases of medical equipment and device systems. (6) Majority of Medical practitioners are HAtrained and hence early application in HA will facilitate future market growth. (7) Private hospitals in HK all make reference to HA procurement practices. (8) Mainland China purchases make strong reference to HK registered and listed products. (9) Hong Kong is a major leader in Asia Harmonization Working Party (AHWP) and a number of Asian countries will make reference to products being registered in HK. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 37
  • 38. Hong Kong: Regulation Controls Relating to Medical Devices ❖ Currently, there is no specific legislation to regulate the importation or sale of medical devices in Hong Kong except those containing pharmaceutical products or emitting ionizing radiation ❖ Voluntary Medical Device Administrative Control System (MDACS) ❖ Pharmaceutical and Drugs Control Office ❖ Radiation Health Unit ❖ Proprietary Chinese Medicine or Chinese Herbs ❖ Health food and nutrition supplements Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 38
  • 39. Advantages of Registering for Voluntary Listing (1) Manufacturers can make device registration while the product sales to HK market are not affected. No time is lost in the process. (2) According to DH advice, products registered under the voluntary system will be transferred direct to the regulation list without another dossier submission. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 39
  • 40. Classification of Medical Devices – Some Definitions ❖ Active medical device ❖ Invasive medical device ❖ Body orifice ❖ Active implantable medical device ❖ Transient, short-term and long-term use ❖ Standalone software(Ref Section 2 of GN-00) Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 40
  • 41. Risk Classification of Medical Devices I II III IV Class I Class 1 of EU System Class III Class 2b of EU System Class II Class 2a of EU System Class IV Copyright © 2013 Pacific Bridge Medical Class 3 of EU System | www.pacificbridgemedical.com 41
  • 42. Thank You! Pacific Bridge Medical Connect with us today. 7315 Wisconsin Avenue, Suite 609E Bethesda, MD 20814 www.pacificbridgemedical.com Click here to contact us for regulatory strategies for your medical device in Asia. Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 42

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