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  5. Technical Seminar
  6. Points to consider in the medical device regulatory submission to the Korean KFDA.

Points to consider in the medical device regulatory submission to the Korean KFDA.

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last updated:Feb 13, 2020

AndTech
AndTech
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★We respond to requests for an easy-to-understand explanation of the Korean pharmaceutical application! ★Sharing know-how on advice and strategies for entering the Korean market based on actual experience.

At Yoshida Legal Office, we have been involved in many administrative responses through our interactions with the KFDA. On the Japanese side, there has been a demand for clear explanations regarding the Korean pharmaceutical application process, and we have been addressing this daily. Therefore, we have decided to hold this seminar to summarize the practical aspects of KFDA applications. Additionally, this seminar will provide the latest information, including recent updates and the background related to the KFDA.

    Technical Seminar
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Points to consider in the medical device regulatory submission to the Korean KFDA.

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Lecturers 1. Yoshida Takashi, Representative of Yoshida Law Office 2. KFDA Regulatory Affairs Personnel residing in South Korea Venue Tokyo Chuo Ward Industrial Hall, 4th Floor, Meeting Room 4 [Tokyo, Chuo Ward] 5-minute walk from Higashi-Nihonbashi Station on the Asakusa Line, Bakuroyokoyama Station on the Shinjuku Line, and Bakurocho Station on the JR Line Date and Time July 14, 2011 (Thursday) 10:30 AM - 4:00 PM Participation Fee 49,350 yen (including tax, lunch, text, and the book "Guidelines for Approval in Korean Medical Device Applications 2011") for up to 2 participants from one company *Members who register by June 30 will receive an early bird discount price of 46,200 yen.

Price information

49,350 yen (including tax, lunch, text, and the book "Guidelines for Approval in Korean Medical Device Applications 2011") for up to 2 people from 1 company.

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P2

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P2

Applications/Examples of results

1. About Korean Pharmaceutical Regulations (1) Legal Regulations of Pharmaceuticals (2) Position of Pharmaceuticals, Medical Devices, Cosmetics, and Quasi-drugs in Pharmaceutical Affairs 2. How to Navigate the Korea Food and Drug Administration (KFDA) Website (1) Navigating the KFDA Website (2) Information Search Methods 3. The Market for Medical Devices in Korea (1) Market Size (2) Production and Import Status of Medical Devices 4. Licensing System for Medical Devices in Korea (1) Organizational Structure of KFDA (2) KFDA Licensing Procedures, Processing Time, and Fees (3) Introduction and Promotion of KFDA Medical Device System (4) Preparation of KFDA Medical Device Technical Documents (5) Required Documents Before KFDA Application (6) KFDA Medical Device Testing 5. Summary of Recent Korean Pharmaceutical News (1) Introduction of Various KFDA News (2) Amendments and Changes to Regulations 6. Perspective and Utilization of the Japanese Pharmaceutical Law Association (1) How to Navigate the Website (2) Utilization Methods in Pharmaceutical Affairs 7. Advice and Strategies for Entering the Korean Market

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AndTech

AndTech

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Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.

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