Medical device clinical trial

Article information

J Korean Med Assoc. 2010;53(9):769-773

Publication date (electronic) : 2010 September 07

doi : https://doi.org/10.5124/jkma.2010.53.9.769

Sung Hwa Hong, MD ^,

Department of Otorhinolaryngology-Head&Neck Surgery, School of Medicine, Sungkyunkwan University, Seoul, Korea.

Research Center for Future Medicine, Samsung Medical Center, Seoul, Korea. sunghwa3574.hong@samsung.com

Received 2010 August 08; Accepted 2010 August 22.

Abstract

The development of new drugs and medical devices has been attributed to constant innovation, and the medical device industry in particular is growing faster than the drug industry. The medical device market in Korea is growing, with an average annual growth rate of 12.6% from 2006 to 2008. The production amount of medical devices categorized as Class 3 or Class 4 increased more rapidly than Class 1 or Class 2 with an increase in portion size. Clinical trials are a crucial process through which the safety and efficacy of medical devices is evaluated prior to allowing them to be used by the public. Recently, the approval rate of clinical trials for medical devices by the Korea Food & Drug Administration has increased, indicating that clinical trials that could be scientifically feasible and ethically justified were planned. To satisfy the increasing need for high quality clinical trials, a total of 6 medical device clinical trial center consortia have been designated by the Ministry of Health & Welfare as of July 2010. Medical devices take significantly less time to get to the market compared to drugs and there is much need for innovation. Therefore, the clinical trial market for new medical devices is expected to grow faster than previously forecast.

Keywords: Medical device; Clinical trial; Health industry

Acknowledgement

This study was supported by a grant of the Korea Healthcare technology R&D Project, Ministry of Health&Welfare, Republic of Korea.(A084152)

References

1. Ahn ME, Choi GH. A developmental process of telemedicine, e-Health&u-Health. J Korean Med Assoc 2009. 521131–1140.

2. Lisman J. The Future of Medical Products Regulation: How Can Innovation be Safeguarded? RAJ Pharma 2008 May;

3. Korea Medical Device Industry Association. Medical Device Production, Export, Import and Repair Record Report 2009.

4. Espicom. The World Medical Markets Fact Book 2008.

5. Korea Food&Drug Administration Available from: http://md.kfda.go.kr/examination/examination_4.jsp.

6. Enforcement Regulation of Act on the Medical Device (Implemented on March 19, 2010)

7. Korea Food&Drug Administration. Food&Drug Statistical Yearbook 2009.

8. Korea Food&Drug Administration. Internal Document of Clinical Trial Management Division 2009.

Article information Continued

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Table 1

Classification of medical device[6]

Table 2

Medical device market trend[3] (unit: million won, %)

^a)amount (year-on-year rate, %)

^b)using standard annual average exchange rate of The Bank of Korea

^c)calculated as Production-Export+Import

Table 3

Amount of manufactured medical devices according to class[3] (unit: million won, %)

^a)amount (percent, %)

Table 4

Authorized clinical trials for medical devices by the Korea Food&Drug Administration[7]

Table 5

Clinical trials for medical devices conducted without authorization by the Korea Food&Drug Administration [8]

Table 6

Clinical trial centers for medical devices designated by the Ministry of Health&Welfare