Medical Device Registration inin South Korea and Taiwan      Medical Device Registration South Korea and Taiwan           ...
Medical Device Registration in South Korea and Taiwan                                        Key Points: South Korea      ...
Medical Device Registration in South Korea and Taiwan                               South Korean Market Appeal            ...
Medical Device Registration in South Korea and Taiwan                             Korean Market Characteristics        •  ...
Medical Device Registration in South Korea and Taiwan                  The South Korean Regulatory Process for            ...
Medical Device Registration in South Korea and Taiwan           The South Korean Regulatory Process, cont’d.              ...
Medical Device Registration in South Korea and Taiwan                                   Steps to KFDA Compliance        1....
Medical Device Registration in South Korea and Taiwan                          Device Status and Classification           ...
Medical Device Registration in South Korea and Taiwan                      KFDA Substantial Equivalence (SE)            Su...
Medical Device Registration in South Korea and Taiwan                   Korea License Holder Requirements            If yo...
Medical Device Registration in South Korea and Taiwan              Class I Devices: Premarket Notification        • Class ...
Medical Device Registration in South Korea and Taiwan                      General Technical File Preparation            F...
Medical Device Registration in South Korea and Taiwan        Safety and Effectiveness Review (SER) Technical              ...
Medical Device Registration in South Korea and Taiwan              SER Technical File Preparation: Clinical Data          ...
Medical Device Registration in South Korea and Taiwan                                  Type Testing Requirements        • ...
Medical Device Registration in South Korea and Taiwan                         KFDA Certified Test Laboratories            ...
Medical Device Registration in South Korea and Taiwan                    Acceptance of Foreign Test Reports               ...
Medical Device Registration in South Korea and Taiwan                                Foreign Test Reports, cont’d.        ...
Medical Device Registration in South Korea and Taiwan                                   Technical File Submissions        ...
Medical Device Registration in South Korea and Taiwan             KFDA Regulatory Timeframes and Costs              KFDA C...
Medical Device Registration in South Korea and Taiwan             KFDA Authorized Third-Party Reviewers           The foll...
Medical Device Registration in South Korea and Taiwan                                Obtaining a Product License          ...
Medical Device Registration in South Korea and Taiwan             Korea Good Manufacturing Practices (KGMP)         Class ...
Medical Device Registration in South Korea and Taiwan                                  KGMP Certification Process         ...
Medical Device Registration in South Korea and Taiwan                                  KGMP Certification, cont’d.        ...
Medical Device Registration in South Korea and Taiwan                                  KGMP Certification, cont’d.        ...
Medical Device Registration in South Korea and Taiwan                                  KGMP Certification, cont’d.        ...
Medical Device Registration in South Korea and Taiwan         Final KFDA Registration and Commercialization          Upon ...
Medical Device Registration in South Korea and Taiwan               Medical Device Registration in TaiwanASIA | EUROPE | N...
Medical Device Registration in South Korea and Taiwan                                                Key Points: Taiwan   ...
Medical Device Registration in South Korea and Taiwan                             Taiwan Market Characteristics         • ...
Medical Device Registration in South Korea and Taiwan               Taiwan Market Characteristics, cont’d.                ...
Medical Device Registration in South Korea and Taiwan                         Regulatory Overview for Taiwan              ...
Medical Device Registration in South Korea and Taiwan              Medical Device Classification in Taiwan                ...
Medical Device Registration in South Korea and Taiwan                                 Quality System Compliance           ...
Medical Device Registration in South Korea and Taiwan                    Quality System Compliance, cont’d.               ...
Medical Device Registration in South Korea and Taiwan                    Quality System Compliance, cont’d.          The T...
Medical Device Registration in South Korea and Taiwan                    Quality System Compliance, cont’d.             Ap...
Medical Device Registration in South Korea and Taiwan                                 Medical Device Compliance           ...
Medical Device Registration in South Korea and Taiwan                 Class I Medical Device Permit License               ...
Medical Device Registration in South Korea and Taiwan             Class II and III Medical Device Permit License         C...
Medical Device Registration in South Korea and Taiwan               New Device Medical Device Permit License            Th...
Medical Device Registration in South Korea and Taiwan                            Taiwan Authorized Representation         ...
Medical Device Registration in South Korea and Taiwan                             Taiwan Agent Responsibilities      •    ...
Medical Device Registration in South Korea and Taiwan                  Final Product Certification Timelines              ...
Medical Device Registration in South Korea and Taiwan                                            Additional Resources     ...
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Medical Device Registration in South Korea and Taiwan

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Medical device markets in South Korea and Taiwan are robust enough to warrant careful consideration from foreign manufacturers looking to expand their business in Asia.

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Medical Device Registration in South Korea and Taiwan

  1. 1. Medical Device Registration inin South Korea and Taiwan Medical Device Registration South Korea and Taiwan Medical Device Registration in South Korea and TaiwanASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  2. 2. Medical Device Registration in South Korea and Taiwan Key Points: South Korea • Reasons to consider Korea • Korean medical device market characteristics • Overview of the Korean regulatory process • Korea’s device classification scheme • The Medical Device Act • In-country Representation requirements • Registration certificate validity • Approval timelines • CostsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  3. 3. Medical Device Registration in South Korea and Taiwan South Korean Market Appeal • Population of 48.8 million* • $1.55 trillion (PPP)**, 13th largest global economy** • Korea’s medical device market totals $2.5 billion *** • Expected to grow at 10-15% annually in next several years*** • An aging population and continued economic growth will result in demands for better healthcare*** *2010 World Bank data ** CIA Fact Book 2011 data *** U.S. International Trade Commission, U.S. Korea Free Trade Agreement: Potential Economy-wide and Selected Sectoral Effects, September 2007.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  4. 4. Medical Device Registration in South Korea and Taiwan Korean Market Characteristics • Large, dynamic economy and medical device market • Fast up-take of new technology • Large target universe • Relationship-based sales • Socialized healthcare system • Heavy regulatory requirements • Difficult to get informationASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  5. 5. Medical Device Registration in South Korea and Taiwan The South Korean Regulatory Process for Medical Devices Medical devices in South Korea are regulated by the Korean Food and Drug Administration (KFDA), within the Ministry of Health and Welfare (MoHW). The legal framework for the regulatory system is based on the Medical Devices Act No. 10564. Medical devices must meet the requirements of the Medical Devices Act, and obtain registration with the KFDA before being sold in the country.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  6. 6. Medical Device Registration in South Korea and Taiwan The South Korean Regulatory Process, cont’d. Relevant Regulations: • KFDA Notification No.2011-82, the Regulations for Approval, Notification, evaluation, etc. effective January 01, 2012 • KFDA Notification No. 2011-72, the Standards for Manufacture, Import and Quality Management of Medical Devices effective April 8, 2012ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  7. 7. Medical Device Registration in South Korea and Taiwan Steps to KFDA Compliance 1. Determine medical device status and classification 2. Determine Substantial Equivalent (SE) availability 3. Korea License Holder assignation 4. Application preparation 5. Product testing (as required) 6. Application (with Technical File as required) review 7. KGMP Certification (as required) 8. Place products on marketASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  8. 8. Medical Device Registration in South Korea and Taiwan Device Status and Classification Class I Class I Specially Class II Class III Class IV Controlled Medium-High Low Risk Medium Risk High Risk Risk Increasing risk to patient or user Medical Devices are classified on risk and intended use into a four tiered systems specified in KFDA Notification 2011-49ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  9. 9. Medical Device Registration in South Korea and Taiwan KFDA Substantial Equivalence (SE) Substantial equivalency shall be supported by scientific rationale or supporting documents. Comparisons based on 5-6 criteria: 1. Indications for Use 2. Mode of Action 3. Raw Materials (for parts that contact the body) 4. Performance 5. Testing Method/Standard 6. Instructions for Use Does your device have a substantial equivalent already sold in Korea? Yes No Safety and Effectiveness Regular Application Review (SER) ApplicationASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  10. 10. Medical Device Registration in South Korea and Taiwan Korea License Holder Requirements If you have no local business presence in South Korea, you must appoint a Korea License Holder (KLH) as your in-country representative. Your KLH coordinates and submits your medical device registration application to the KFDA on your behalf.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  11. 11. Medical Device Registration in South Korea and Taiwan Class I Devices: Premarket Notification • Class I standard device applications are considered accepted to the KFDA branch office • Class I Special Control device applications are reviewed and processed by the KFDA branch office • The Premarket Notification contains basic information on your medical deviceASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  12. 12. Medical Device Registration in South Korea and Taiwan General Technical File Preparation For Class II, III and IV medical devices with proven Substantial Equivalence, manufacturers must prepare a General Technical File. The General Technical File is similar to a US FDA 510(k) submission.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  13. 13. Medical Device Registration in South Korea and Taiwan Safety and Effectiveness Review (SER) Technical File Preparation Manufacturers of Class II, III and IV devices without Substantial Equivalence must prepare SER Technical File submissions. The SER Technical File is similar to the US Premarket Notification submission.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  14. 14. Medical Device Registration in South Korea and Taiwan SER Technical File Preparation: Clinical Data Requirements • Clinical data must be included in SER Technical File submissions to the KFDA • Clinical trials in Korea are typically not required • KFDA often accepts clinical data that has already been approved by an OECD member country or published in an SCI-listed scientific journalASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  15. 15. Medical Device Registration in South Korea and Taiwan Type Testing Requirements • All Class II, III and IV medical devices must undergo type testing by an independent laboratory. • The Korea Testing Lab (KTL) is authorized to conduct type testing on all categories of medical devices • Existing equivalent product testing may meet this requirement, as long as it complies with ISO, IEC, ASTM or GLP standards.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  16. 16. Medical Device Registration in South Korea and Taiwan KFDA Certified Test Laboratories Company Name Device Category 1. Korea Testing Laboratory all categories 2. Korea Testing Certification limited categories 3. Korea Conformity Laboratories limited categories 4. Korea Testing & Research Institute limited categories 5. Seoul National U. Hospital Clinical Research Institute limited categories 6. Yonsei U. Hospital Medical Technology Evaluation Center limited categories 7. Yonsei U. Dental College Dental Products Testing & Evaluation Center dental materials only 8. Kyung-hee U. Dental College, Open Laboratories for Dental Products dental materials only 9. Kyungpook University – KDMTEC dental materials only 10. Clinical Dental Institute, Seoul National University Dental Hospital dental materials only 11. KOREC Testing Laboratory for Medical Devices limited categories 12. Korea Institute of Medical Technology limited categories 13. Korea Institute of Medical Device Assesment (KIMDA) limited categoriesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  17. 17. Medical Device Registration in South Korea and Taiwan Acceptance of Foreign Test Reports • Determination made by KFDA-authorized test labs • Electrical Test Reports o follow IEC standards o written in CB scheme form o certified by National Certification Body Testing Lab • Biological Test Reports o tests must be carried out in according to ISO, ASTM or other international standards o tests must be carried out according to GLP standards • Physico-Chemical Test Reports o test reports issued by ISO 17025 certified labsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  18. 18. Medical Device Registration in South Korea and Taiwan Foreign Test Reports, cont’d. • Performance Test Reports o manufacturer’s test reports if covered by ISO 13485 with, o a full description of test protocol o raw data may be required on a case-by-case basis o signature by lab technician and supervisors o notarization by notary public o test report issued by ISO 17025 certified labs o foreign test reports accepted when tests cannot be repeated in Korea • Information accepted by the government for approval in the country of manufacture for approval only when submitted with a certificate of such fact by the governmentASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  19. 19. Medical Device Registration in South Korea and Taiwan Technical File Submissions Once your Technical File is prepared, it must be submitted to the appropriate reviewer for approval. Technical File Type Review Method Reviewed by Third Party, approved Class II General by KFDA Class II SER Class III General Class III SER Reviewed and approved by KFDA Class IV General Class IV SERASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  20. 20. Medical Device Registration in South Korea and Taiwan KFDA Regulatory Timeframes and Costs KFDA Classification Review Time Fees Class I N/A $35 Class I Specially Controlled 10 Days $35 Class II Regular 35 Days $1,500 Class II SER 80 Days $450 Class III and IV Regular 65 Days $195 Class III and IV SER 80 Days $450ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  21. 21. Medical Device Registration in South Korea and Taiwan KFDA Authorized Third-Party Reviewers The following companies are authorized by the KFDA to perform reviews of Class II General Technical Files: Company Name 1. Korea Testing Laboratory 2. Korea Testing Certification 3. Korea Conformity Laboratories 4. Korea Testing & Research Institute 5. SGS Korea 6. TÜV SÜD KoreaASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  22. 22. Medical Device Registration in South Korea and Taiwan Obtaining a Product License Once your General or SER Technical File is approved, you must submit the document to KFDA in order to obtain a Product License.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  23. 23. Medical Device Registration in South Korea and Taiwan Korea Good Manufacturing Practices (KGMP) Class I Specially Class II Class III Class IV Controlled • Manufacturers of Class I Specially Controlled, II, III and IV devices must implement a quality systems compliant with Korea Good Manufacturing Practices (KGMP) • Similar to ISO 13485 and US Quality System Regulation (21 CFR Part 820) • KFDA Notification No.2011-72, the Standards for Manufacture, Import and Quality Management of Medical Device went into effect on April 08, 2012 *on-site audits may be required for new manufacturers or any manufacturer with quality problem reported within 3 yearsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  24. 24. Medical Device Registration in South Korea and Taiwan KGMP Certification Process Service Working days Remarks Review QMS data and prepare 30 days (estimate) After review of the basic documentation KGMP Certification application Application submitted to 3rd 20 days On site inspection of the manufacturing site/s party reviewer for review and may be requested by the KFDA and will be processing performed at the KLH Application submitted to KFDA 10 days for processing and certification On-site inspection of Korea Schedule will be known On site inspection of the foreign manufacturing License Holder facility (typically within 7 days of site/s may subsequently be requested by the within 30 days of application application submission KFDA submission) – if requested (performed by the KFDA and 3rd party review) KGMP Certification issued by 7 days Device legally permitted to be imported into KFDA KoreaASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  25. 25. Medical Device Registration in South Korea and Taiwan KGMP Certification, cont’d. • Estimated timeframe for KGMP Certification: 3-4 months (performed in parallel to product registration review) • KGMP Certificate valid for 3 yearsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  26. 26. Medical Device Registration in South Korea and Taiwan KGMP Certification, cont’d. Establishments Inspection Remarks Importer (KLH) YES Importer must submit KGMP application Contract Manufacturer Must be labeled as "Manufacturer“ (Article 27, YES (Entire process) paragraph 1 No. 6 of the Enforcement regulation) Foreign Legal Manufacturer Must be labeled as "Person who requested (Not involved in actual NO manufacturing“ (Article 27, paragraph 1 No. 6 of the manufacturing process) Enforcement regulation) Importer must submit a list of all manufacturers involved in the manufacturing processes including all Contract Manufacturer the sub-component manufacturers. KFDA will decide case specific (Component) importance of each activity and if sub-component manufacturers activity is critical to the quality of final product, KFDA will inspect the site. Labeler case specific low probability Packager case specific low probability Contract sterilizer case specific high probabilityASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  27. 27. Medical Device Registration in South Korea and Taiwan KGMP Certification, cont’d. KGMP compliance audits are performed by the KFDA as well as third-party inspectors. Both manufacturers and their Korea License Holders are subject to KGMP audits. Third Party KGMP Inspectors 1. Korea Testing Laboratory 2. Korea Testing Certification 3. Korea Conformity Laboratories 4. Korea Testing & Research InstituteASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  28. 28. Medical Device Registration in South Korea and Taiwan Final KFDA Registration and Commercialization Upon approval of your medical device registration application, the KFDA will issue a Certificate of Product Approval as well as a KGMP Certificate. Your KLH is then responsible for clearing your products through Korean Customs following importation.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  29. 29. Medical Device Registration in South Korea and Taiwan Medical Device Registration in TaiwanASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  30. 30. Medical Device Registration in South Korea and Taiwan Key Points: Taiwan • Why Taiwan? • Characteristics of the Taiwanese medical device market • Overview of Taiwan’s regulatory process • Device classification scheme • Taiwan Pharmaceutical Affairs Law • In-country representation • Registration certificate validity • Length of process • CostsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  31. 31. Medical Device Registration in South Korea and Taiwan Taiwan Market Characteristics • Population of 23.2 million • With GDP of $880 billion* (PPP) Taiwans economy ranks 20th worldwide* • Taiwan’s medical device market is estimated at $600 million (4th largest in Asia) • Influencer on larger Chinese medical device market **CIA World Fact Book 2012ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  32. 32. Medical Device Registration in South Korea and Taiwan Taiwan Market Characteristics, cont’d. • Compact, sophisticated economy and medical device market • High percentage target universe • Relationship-based sales • Socialized healthcare systemASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  33. 33. Medical Device Registration in South Korea and Taiwan Regulatory Overview for Taiwan Classification of medical devices Manufacturer shall identify the intended use of its medical device to verify the product is eligible for medical device regulations. According to its intended use, medical device can be classified as I (low risk), II (moderate risk), III (high risk) and high risk or new medical device (no equivalent device approved by DOH). Requirement Class I Class II Class III New Good Manufacturing No (except for those are Required Required Required Practice sterile or with measuring function) Medical Device Required Required/ Required/ Required/ License technical review technical review technical review Clinical Data Not required Not required Required for IVD and DOH Required designated medical devicesASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  34. 34. Medical Device Registration in South Korea and Taiwan Medical Device Classification in Taiwan Class I Class II Class III New No Substantial Low Risk Moderate Risk High Risk Equivalence Increasing risk to patient or user Regulatory pathway is determined by the device classification according to the Taiwan FDA Pharmaceutical Affairs Act, Article 13. Classification is based on the intended use of the device.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  35. 35. Medical Device Registration in South Korea and Taiwan Quality System Compliance As part of the medical device registration process in Taiwan, the Taiwan Food and Drug Administration (TFDA) requires two sequential processes: 1. Manufacturing facility licensing/quality system documentation (QSD Letter) 2. Medical Device Permit (PR) licensingASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  36. 36. Medical Device Registration in South Korea and Taiwan Quality System Compliance, cont’d. Manufacturing Facility License (QSD Letter) • USD $750 application fee required • Processing takes six months • QSD letter valid for three yearsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  37. 37. Medical Device Registration in South Korea and Taiwan Quality System Compliance, cont’d. The TFDA allows a simplified QSD application for US manufacturing facilities and EU facilities with ISO 13485:2003 certification issued by qualified Notified Bodies, but the same fees and processing times apply. • Simplified application requires EIR for US manufacturers or Audit Report for EU manufacturers • Simplified application requires FSC or CFG notarization by Taiwan Representative Office in the country or origin (the regular route does not). • QSD review of actual manufacturing site. • No published timelines for application review by the TFDA.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  38. 38. Medical Device Registration in South Korea and Taiwan Quality System Compliance, cont’d. Application for Qualification of Medical Device Good Manufacturing Practice (GMP) • Medical Device Good Manufacturing Practice (GMP) Inspection of foreign manufacturers is conducted through Quality System Documentation review. • Foreign manufacturer or its initial importer may apply for on-site inspection in accordance with Good Manufacturing Practice, ISO 13485:2003 or CNS 15013.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  39. 39. Medical Device Registration in South Korea and Taiwan Medical Device Compliance There are two main registration routes for medical devices in Taiwan: Medical Device Permit (PR) License “New Device” Application (Class II or III) •US $375 application fee •US $1,125 application fee •US $55 license fee •12 months processing time •Six months processing time •Valid for five years •Valid for five years •Must be monitored for three yearsASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  40. 40. Medical Device Registration in South Korea and Taiwan Class I Medical Device Permit License Class I medical device Permit License applications must include: • Application form • Copy of your Pharmaceutical Medical Device Manufacturer/Distributor LicenseASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  41. 41. Medical Device Registration in South Korea and Taiwan Class II and III Medical Device Permit License Class II and III medical device Permit License applications should include the following: •Application form •Authorization letter from original manufacturer •Two copies of Chinese labeling, •Two copies of preclinical test, quality instructions for use and packaging inserts control procedure and test reports •Copy of Pharmaceutical License for •Two copies of product structure, material, Medical Device Manufacturer/Distributor specifications, intended use and related documents •Truth and Accuracy statement •Copy of GMP/QSD compliance letter •Free Sale Certificate issued by country of •Radioactive safety information, if origin applicableASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  42. 42. Medical Device Registration in South Korea and Taiwan New Device Medical Device Permit License The same information required for Class II and III Permit License applications are required, as well as the following materials: • Literature review and related study reports • Clinical investigation reports • Review by eight to 10 national university hospitals, if necessary TFDA review time: 12 months TFDA review fee: $1,125ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  43. 43. Medical Device Registration in South Korea and Taiwan Taiwan Authorized Representation Requirements Foreign manufacturers with no local business presence in Taiwan must appoint a Taiwan Agent to interact with the TFDA on their behalf. Your Taiwan Agent must: • Be based in Taiwan • Formally licensed with appropriate scope of business: – F108031 medical device wholesale – F208031 medical device retail – F401010 international businessASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  44. 44. Medical Device Registration in South Korea and Taiwan Taiwan Agent Responsibilities • Management of Advertisements for Medical Devices (Taiwan FDA Pharmaceutical Affairs Act, Article 65) • Complaint Handling (Taiwan FDA Pharmaceutical Affairs Act, Article 145) • Serious Adverse Event (SAE) Reporting (Taiwan FDA Pharmaceutical Affairs Act, Article 145)ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  45. 45. Medical Device Registration in South Korea and Taiwan Final Product Certification Timelines Class I Less than one month Class II Six months Class III 14 to 16 months New 18 to 24 months PR Licenses are valid for five years. QSD letters are valid for three years.ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
  46. 46. Medical Device Registration in South Korea and Taiwan Additional Resources • South Korean medical device regulations: http://www.emergogroup.com/resources/regulations-south-korea • South Korea medical device regulatory consulting services from Emergo Group: http://www.emergogroup.com/services/korea • Taiwan medical device regulations: http://www.emergogroup.com/resources/regulations-taiwan • Taiwan medical device regulatory consulting services from Emergo Group: http://www.emergogroup.com/services/taiwan Bryan Gilburg Emergo Group|VP of Business Development US office: +1.512.327.9997ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
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