Medical Device Approval and Certification System Of East Asia

Free sample

In recent years, even though a medical device industry has been grown rapidly as a next generation global industry, most of markets are dominated by some of major countries. A medical device is distinct from general goods; it requires not only ordinary medical engineering R&D knowledge, but also it involves with each phases of specific market knowledge, experience, and expertise from development to commercialization according to complicated regulatory affairs.  Moreover, since the purpose of manufactured medical device is usually not only for domestic market but for overseas expansion, expertise of global medical device industry knowledge are needed, such as each country’s medical device law, data of medical device usage and etc…

The book provides comprehensive, yet practical knowledge of product planning, research, development, manufacturing, certification and approval, and distribution of medical device in order to enable readers to conduction of business easily through general R&D education as well as essential subject, medical device approval and certification system. The main purpose of book is to foster practical medical device experts through understanding of medical device approval and certification system of East Asia including Korea, Japan, and China.

Since the author has had an experienced working in Ministry of Food and Drug Safety (MFDS), especially in medical device certification department as well as an educator in Universities for a long time, the author contains practical-knowledge-oriented information such as problems and corresponding strategies of each country in an aspect of regulatory affairs based on 『global certification and approval for medical device』, which are distinct from a regular textbook: engineering-education-oriented information for medical device manufacturing. This book describes information of regulatory affairs easily for various class of readers: from a undergraduate and graduate student who are interested in medical device industry to personnel who are performing medical device regulation related work.

The contained information is based on public announced material from each country’s regulatory authority. However, the contained information may change in the future due to characteristics of regulatory affairs. Therefore, the author will continuously publish revised edition and respectfully accept requests for revision and improvement.


2016. December

Gyu Ha Ryu, ph.D

Read more

Additional Information

Read more
Published on
Dec 16, 2016
Read more
Read more
Read more
Read more
Medical / Reference
Read more
Content Protection
This content is DRM protected.
Read more
Read Aloud
Available on Android devices
Read more

Reading information

Smartphones and Tablets

Install the Google Play Books app for Android and iPad/iPhone. It syncs automatically with your account and allows you to read online or offline wherever you are.

Laptops and Computers

You can read books purchased on Google Play using your computer's web browser.

eReaders and other devices

To read on e-ink devices like the Sony eReader or Barnes & Noble Nook, you'll need to download a file and transfer it to your device. Please follow the detailed Help center instructions to transfer the files to supported eReaders.
©2018 GoogleSite Terms of ServicePrivacyDevelopersArtistsAbout Google|Location: United StatesLanguage: English (United States)
By purchasing this item, you are transacting with Google Payments and agreeing to the Google Payments Terms of Service and Privacy Notice.