medical device registration in south korea and taiwan

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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 • Costs



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.



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 information



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.



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, 2012



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 market



Device Status and Classification Class I

Specially Controlled

Class II Class III Class IV

Low Risk Medium Risk Medium-High Risk High 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 2011-49

Class I



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

Yes No

Regular Application Safety and Effectiveness Review (SER) Application

Does your device have a substantial equivalent already sold in Korea?



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.



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 device



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.



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.



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 journal



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.



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 categories



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 labs



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 government



Technical File Submissions

Technical File Type Review Method

Class II General Reviewed by Third Party, approved by KFDA

Class II SER Class III General

Class III SER Class IV General

Class IV SER

Reviewed and approved by KFDA

Once your Technical File is prepared, it must be submitted to the appropriate reviewer for approval.



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 $450



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 Korea



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.



Korea Good Manufacturing Practices (KGMP)

• 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

Class I Specially Controlled Class III Class IV

*on-site audits may be required for new manufacturers or any manufacturer with quality problem reported within 3 years

Class II



KGMP Certification Process Service Working days Remarks

Review QMS data and prepare KGMP Certification application

30 days (estimate) After review of the basic documentation

Application submitted to 3rd party reviewer for review and processing

20 days On site inspection of the manufacturing site/s may be requested by the KFDA and will be performed at the KLH

Application submitted to KFDA for processing and certification

10 days

On-site inspection of Korea License Holder facility (typically within 30 days of application submission) – if requested

Schedule will be known within 7 days of application submission (performed by the KFDA and 3rd party review)

On site inspection of the foreign manufacturing site/s may subsequently be requested by the KFDA

KGMP Certification issued by KFDA

7 days Device legally permitted to be imported into Korea



KGMP Certification, cont’d.

• Estimated timeframe for KGMP Certification: 3-4 months (performed in parallel to product registration review)

• KGMP Certificate valid for 3 years



KGMP Certification, cont’d. Establishments Inspection Remarks

Importer (KLH) YES Importer must submit KGMP application Contract Manufacturer (Entire process) YES Must be labeled as "Manufacturer“ (Article 27,

paragraph 1 No. 6 of the Enforcement regulation) Foreign Legal Manufacturer (Not involved in actual manufacturing process)

NO Must be labeled as "Person who requested manufacturing“ (Article 27, paragraph 1 No. 6 of the Enforcement regulation)

Contract Manufacturer (Component) case specific

Importer must submit a list of all manufacturers involved in the manufacturing processes including all the sub-component manufacturers. KFDA will decide importance of each activity and if sub-component manufacturer's 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 probability



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 Institute



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.



Medical Device Registration in 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 • Costs



Taiwan Market Characteristics

• Population of 23.2 million • With GDP of $880 billion* (PPP) Taiwan's 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 2012



Taiwan Market Characteristics, cont’d.

• Compact, sophisticated economy and medical device market

• High percentage target universe • Relationship-based sales • Socialized healthcare system



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 Practice

No (except for those are sterile or with measuring function)

Required Required Required

Medical Device License

Required Required/ technical review

Required/ technical review

Required/ technical review

Clinical Data Not required Not required Required for IVD and DOH designated medical devices

Required



Medical Device Classification in Taiwan Class I Class II Class III New

Low Risk Moderate Risk High Risk No Substantial 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.



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) licensing



Quality System Compliance, cont’d. Manufacturing Facility License (QSD Letter)

• USD $750 application fee required • Processing takes six months

• QSD letter valid for three years



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.



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.



Medical Device Compliance

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 years

There are two main registration routes for medical devices in 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 License



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, instructions for use and packaging inserts

•Two copies of preclinical test, quality control procedure and test reports

•Copy of Pharmaceutical License for Medical Device Manufacturer/Distributor

•Two copies of product structure, material, specifications, intended use and related documents

•Truth and Accuracy statement •Copy of GMP/QSD compliance letter

•Free Sale Certificate issued by country of origin

•Radioactive safety information, if applicable



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: $1,125



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 business



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)



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.



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: +1.512.327.9997

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medical device registration in south korea and taiwan

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