Regulation of Medical Devices in Hong Kong Dr Terence CHEUNG - PowerPoint PPT Presentation

Regulation of Medical Devices in Hong Kong Dr Terence CHEUNG Principal Medical and Health Officer Department of Health, Hong Kong SAR 1

Content  Background  Latest Legislative Development  Medical Device Administrative Control System – Medical Device Listing – Safety Alerts and Adverse Incidents Reporting We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority 2

Background 3

Medical Device Market in Hong Kong (1)  Hong Kong is a major hub for re-export of medical devices Imported and locally manufactured medical devices Domestic use, 5% Re-export, 95%  It is estimated that there are  50+ local manufacturers  3 000+ medical device suppliers, including authorised representatives, importers and distributors Source: BIA Report 4 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Medical Device Market in Hong Kong (2)  Mar arket V Value alue Esti timate ated US$ $ 300 300 milli illion (2017) 2017)  Market S et Size ~ 40 000 ~ 4 000 medic edical dev devices • including general medical devices and in vitro diagnostic medical devices (IVDMDs) • ~ 50 ％ is Class I general medical devices  Lar Large gest Hospi pital tal Author ority ty (HA) HA) end end-us user er • accounts for approximately 70% - 90% of all the medical device purchased locally Source: BIA Report & Export.gov 5 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Latest Legislative Development 6

Regulation of Medical Devices  Currently, there is no specific legislation that regulates the manufacture, import, sale and use of medical devices in Hong Kong  Other related legislations Radi adiat ation on Ordi dinan nance (Cap ap 303) 303) Phar harmac acy and and Poi oisons ons Ordi dinan nance e (Cap ap 138) 138) Undes ndesirab able Medi edical al Adv dver ertisemen ents Ordi dinan nance e (Cap ap 231) 231) Cons onsum umer er G Goods oods Saf afet ety Ordi dinan nance ( e (Cap ap 456) 456) Tel elec ecom ommuni nicat ations ns Ordi dinan nance ( e (Cap ap 106) 106) 7 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Medical Device Legislative Progress Statutory Regulation of Medical Devices 2019 Listing of Class B/C IVDMDs 2018 Refined Legislative Proposal Focusing on (anticipated) Pre-market and Post-market control of MD 2015-2016 Consultancy Study on the Control of Use of Selected MD 2015 Listing of Distributors 2011-2013 Business Impact Assessment 2009 Listing of Class D IVDMD 2007–2008 Regulatory Impact Assessment 2007 Listing of Local Manufacturers and Importers 2006 Recognition of Conformity Assessment Bodies 2005 Listing of Class II/III MD 2003 Proposed Regulatory Framework comprising Pre-market Control, Post-market 2004 Listing of Class IV MD Control and Control on Use of High-risk MD Medical Device Administrative Control System 2003 Public Consultation 8 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Latest Regulatory Framework Focus on pre-market control and post-market control Pre-market control To ensure medical devices Use Control conform with the requirements To restrict the use of on safety, quality, performance, certain high-risk and efficacy before allowing medical devices them to be placed on the market Post-market control To enable swift control measures against defective or unsafe medical devices 9 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Medical Device Administrative Control System (MDACS) 10

Medical Device Administrative Control System (MDACS)  Voluntary  Adopting a risk-based approach recommended by Global Harmonization Task Force (GHTF)  Taking into account local situations 11 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Aims of MDACS To provide an opportunity to collect more information and To raise public awareness on feedback from the industry as a the safe use of medical devices reference to fine tune the long- term regulatory system To enable traders to familiarise To prepare for smooth transition themselves with the future to the future statutory system mandatory requirements 12 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Current MDACS Medical Device Administrative Control System (MDACS) Pre-market Control Post-market Control Listing System 1. Medical Device Listing Medical Device Safety  General medical Conformity Assessment Alerts System devices (Class II, III, IV) Bodies (CAB) Recognition &  IVDMDs (Class D) Scheme Adverse Incidents Reporting System 2. Trader Listing  Local Responsible Person (LRP)  Local manufacturer  Importer  Distributor 13 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Medical Device Listing Safety Listing Efficacy / Quality Performance We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority 14

Medical Device Listing Routes Engage Local / Overseas Medical Device Manufacturer Designate Recognized Local Responsible Person CAB (LRP) Conformity Apply Assessment Refer erenc encing M ng Market keting ng Approval val CAB C Certific tificate (Australia/Canada/EU/Japan/US/ CFDA) Medical Device Control Office (MDCO) Approve 12 weeks upon all supporting documents received Validity: 5 years Listed medical device Application Fee: Free 15 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Listed Medical Device Listed medical device (active) ： 3 623^ Class D IVDMD 1.6% Clas ass IV IV gener general Clas ass II II gener general medi edical dev device medi edical dev device 31.3% 31.3% 33.1% 33.1% Clas ass III III gener general al medi edical dev device 34% 34% Note: ^ As of Jul 2018 16 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Safety Alerts and Adverse Incidents Reporting 17

Medical Device Safety Alert System MD manufacturer or MD manufacturer, supplier to conduct supplier & LRP Product Recall Monitor / Overseas regulatory Notify affected users Investigate authorities' websites (e.g. Hospitals) Repor ort Action on HCPs, hospitals and Letters to HCPs MDCO DCO healthcare institutions Ri Risk sk Analys ysis  Degree of Press Release seriousness Users & Patients  Risk to different population  Sales & distribution Media Messages on  Affected users MDCO website 18 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

Adverse Incident Reporting LR LRP Other ther S Sour ources The he Inc ncident led ed to o one one of of t the he follow owing outcom omes ： MD Manufacturer or supplier  Death of a patient, user or other person HCPs, Hospitals &  Serious injury of a patient, user Healthcare Institutions or other person Users & Patients  No death or serious injury occurred by the incident might Media lead to death or serious injury of a patient, user or other person if the incident recurs MDCO DCO Press Release Risk Communication MD manufacturer or supplier MD manufacturer or Case Investigation to conduct investigation & supplier to conduct report the progress and product recall results to MDCO 19 We build a healthy Hong Kong and aspire to be an internationally renowned public health authority We build a healthy Hong Kong and aspire to be an internationally renowned public health authority