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Kobridge medical devices registration in South Korea

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Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767

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Kobridge medical devices registration in South Korea

  1. 1. Medical Device Registration in South Korea Nicolas Clary Kobridge Consulting
  2. 2. Today’s Topics • Korean medical device market characteristics • Overview of the Korean regulatory process • Common framework • Comparison with US and EU process • Definitions • General Steps • Classification • Substantial Equivalence • In-country Representation requirements • Pre-market process (product license) • Korea Good Manufacturing Practices (KGMP)
  3. 3. Easier than it seems Lost ? Easier than you would think…
  4. 4. The MARKET
  5. 5. The Market • Similar as US and EU market • Established market • Opportunities based on replacement of the installed base or new technologies • Very regulated and « Opaque » market • More similarities with US market and regulations
  6. 6. The Market • Most doctors study in US then expect to find the same technology in Korea • High influence on the choice of products by doctors especially when used in US • The market path could be then first US clearance and then South Korea
  7. 7. South Korean Regulatory Process
  8. 8. The South Korean Regulatory Process for Medical Devices Since 2013: The former Korea Food and Drug Administration (KFDA), an agency under MHW, regulating all Medical Devices was promoted to ministry level: Ministry of Food and Drug Safety (MFDS). 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 MFDS before being sold in the country.
  9. 9. The major steps 1. Determine the class of the product 2. Establish an equivalence 3. Assign a « License Holder » 4. Prepare the file 5. Tests 6. Review (with or without technical file) 7. KGMP certification (if required) 8. Place on the market
  10. 10. General Consideration about framework
  11. 11. Where to start from?  Most applicants have their products already registered in US or EU.  Therefore it is useful whenever possible to do a comparison analysis between the 3 markets
  12. 12. Participants in ensuring the safety of medical device
  13. 13. Interested parties of medical devices in Korea, EU and USA Korea EU USA Medical Device Act Medical Device Directive Federal Food Drug & Cosmetic Act Manufacturer Manufacturer Manufacturer Registered Importer Authorised Representative U.S. Agents MFDS Notified Body FDA Medical Device Technical Document Review Agency Third Party
  14. 14. Common stages of government regulations
  15. 15. Common framework for medical device regulations STAGE PRE-MARKET PLACING ON-MARKET POST-MARKET CONTROL/ MONITOR PRODUCT SALE AFTER-SALE/USE PERSON MANUFACTURER VENDOR VENDOR/USER Items or activities regulated Device attributes • Safety and performance Establishment registration • List products available or in use • Requires vendor to fulfill after-sale obligations Surveillance/vigilance • After-sale obligations • Monitoring of device’s clinical performance • Problemidentification and alerts Manufacturing • Quality systems Labelling • Accurate description of product • Instructions for use Advertising • Prohibits misleading or fraudulent advertisement
  16. 16. Definition
  17. 17. Definition of Medical Device  Korea (Medical Device Act) - Chapter1, Article 2  For the purpose of this Act, the term "medical device" means any instrument, machine, contrivance, material or similar article that is used on human beings or animals either alone or in combination with other devices and that falls under any of the following Items provided below. However, drugs or quasi-drugs under the Pharmaceutical Affairs Act or, among the disabled-assistive-devices under Article 65 of the Act for Welfare of the Disabled, artificial limbs and orthotics shall be excluded:  1. Articles used for the purpose of diagnosis, cure, alleviation, treatment, or prevention of illness;  2. Articles used for the purpose of diagnosis, cure or alleviation of or compensation for an injury or disability;  3. Articles used for the purpose of test, replacement, or modification of the structure or functions [of the body]; or  4. Articles used for the purpose of control of conception.
  18. 18. Definition of Medical Device  EU(MedicalDevice Directive –93/42/EEC amended by 2007/47/EC) - Article 1  ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:  -diagnosis, prevention, monitoring, treatment or alleviation of disease,  -diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,  -investigation, replacement or modification of the anatomy or of a physiological process,  -control of conception,  and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
  19. 19.  USA (the Federal Food Drug & Cosmetic Act) - 201(h)  A device is"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:  •recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,  •intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or  •intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."  Definition of Medical Device
  20. 20. Definition of Medical Device  Comments on the different definitions  The main difference between the Korean definition and the other two is:  In Korea, drugs and quasi-drugs are exclude from the scope of the medical devices  Caution: some gels, lotions or similar product could fall in that category
  21. 21. Summary of the major steps
  22. 22. Steps to MFDS 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 market
  23. 23. Classification
  24. 24. Device Status and Classification Class 1 (low risk) Class 2 (Medium Risk) Class 3 (Medium- High Risk) Class 4 (High Risk) Increasing risk for the patient
  25. 25. Classification of Medical Device Korea EU USA KFDA Notification No. 2010-91 MDD Annex IX 21 CFR 862-892 Class 1 Class 2 Class 3 Class 4 Class I , Class I (sterile, measure)* Class IIa Class IIb Class III Class I Class II Class III Classification of medical devices are already defined Classify according to the classification Rule (Rule 1 ~ Rule 18) Classification of medical devices are already defined
  26. 26. Conformity assessment procedure Class of medical devices Risk classification Approval or Certification Class 4 High risk Product approval by MFDS Clinical data Class 3 Medium risk Product approval by MFDS Class 2 Low risk Product approval by MFDS Technical document review by 3rd Party Class 1 Extremely low risk Product notification to MFDS
  27. 27. Substantial Equivalence
  28. 28. MFDS Substantial Equivalence (SE) Substantial equivalency is supported by proper scientific rationale or supporting documents. A comparison table exists for each category of product with the following criteria:  Intended use  Principle of action  Raw material (for patient contact)  Performance  Testing method / standard  Instruction for use
  29. 29. MFDS Substantial Equivalence (SE) If the device has a substantial equivalent already sold in Korea no SER (Safety and Effectiveness Review) is needed. On the contrary SER is required if the equivalency cannot be proven.
  30. 30. Classification of Medical Device Korea EU USA Substantial Equivalence (SE) None Predicate Device SER (Safety and Effectiveness Review) None PMA (Pre-Market Application)
  31. 31. In-Country Representation
  32. 32. A strategy you must define
  33. 33. Korea License Holder Requirements The role of the Korea License Holder (KLH) is to coordinates and submits your medical device registration application to the MFDS on your behalf. It is essential to appoint a KLH as your representative if you don’t have any local business in South Korea
  34. 34. The strategy 3 Options:  Distributor only (the distributor takes care of everything): registration, licenses, post-market follow-up, sales, marketing  License holder + distributor: same as above except license holder does registration, licenses, post-market follow-up  Subsidiary: establish your subsidiary in South Korea. The subsidiary becomes the license holder. A consultant takes care of the registration.
  35. 35. Different entities involved Korea EU USA Medical Device Act Medical device, in-vitro diagnostic directives Federal Food Drug & Cosmetic Act Manufacturer Manufacturer Manufacturer License Holder European Representative U.S. Agents MFDS Notified Body FDA Third Party Third Party
  36. 36. Pre-market process (product license)
  37. 37. Class I Devices: Premarket Notification • Class I standard device applications are considered accepted to the MFDS branch office • The Premarket Notification contains basic information on your medical device
  38. 38. 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.
  39. 39. 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.
  40. 40. SER Technical File Preparation: Clinical Data Requirements • Clinical data must be included in SER Technical File submissions to the MFDS • 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 journal
  41. 41. Type Testing Requirements • All Class II, III and IV medical devices must undergo type testing by an independent laboratory. • Existing equivalent product testing may meet this requirement, as long as it complies with ISO, IEC, ASTM or GLP standards.
  42. 42. MFDS Certified Test Laboratories  14 certified test laboratories  Some of them have a full scope  Other have limited scope  Some are specialized in dental products  Determination of the acceptance of foreign test reports made by MFDS-authorized test labs
  43. 43. Technical File Submissions Once your Technical File is prepared, it must be submitted to the appropriate reviewer for approval. Class 2: reviewed by 3rd party, approved by MFDS Class 2,3,4 (SER or not): reviewed and approved by MFDS
  44. 44. KFDA Regulatory Timeframes and Costs MFDS Classification Review Time Fees Class 1 NA $35 Class 2 35 days $1500 Class 2 SER 80 days $450 Class 3 and 4 65 days $195 Class 3 and 4 80 days $450 SER
  45. 45. MFDS Authorized Third-Party Reviewers There are 6 companies authorized by the MFDS to perform reviews of Class 2 General Technical Files. It includes: Notified Bodies Korean test laboratories
  46. 46. Product License Once the technical file (SER or not) is approved, the submission process continues in order to obtain the product license It is recommended to submit at the same time the request for KGMP certificate
  47. 47. Korea Good Manufacturing Practices (KGMP)
  48. 48. An inspection ? Very much similar as an ISO 13485 audit
  49. 49. Korea Good Manufacturing Practices (KGMP) Korea EU US KFDA Notification No. 2010-93(Amended on December 27, 2010) Standards for Manufacture, Import and Quality Management of Medical Device EN ISO 13485: 2012 21 CFR Part 820 Quality System Regulation (QS)/ Good Manufacturing Practices (GMP) Annex II Section 3 (Quality system) Section 5 (Surveillance) Annex V Section 3 (Quality system) Section 4 (Surveillance) Annex VI Section 3 (Quality system) Section 4 (Surveillance)
  50. 50. Korea Good Manufacturing Practices (KGMP)  Manufacturers of class 2, class 3 and class 4 are required to comply with KGMP requirements  The quality system compliant with KGMP is very much similar to ISO 13485  Onsite verification of the data from the Device Master Record
  51. 51. KGMP Certification Process  Preparation of the documents  Submission 2 months before the expected date of the inspection (in parallel with the submission of the technical file)  Review by 3rd Party and MFDS  Onsite Inspection  Issue the certificate (valid 3 years)
  52. 52. KGMP Certification Process KGMP inspections are performed by MFDS inspector and 3rd Party 4 Korean laboratories are accredited to perform KGMP inspection
  53. 53. Final registration Following the approval, MFDS delivers a product license and a KGMP certificate Customs clearance of the product is done by the “license holder”
  54. 54. Thank You ! Nicolas Clary Kobridge Consulting +82 2 3450 1690 Nicolas.clary@kobridgeconsulting.com www.kobridgeconsulting.com

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