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|Other Titles:||The Impact of Competing Regulatory Requirements of Pre-Market Registration and Patent Protection on Investing In the Research and Development of High-End Medical Device: Magnetic Resonance Image Guided High Intensity Focused Ultrasound System|
Exclusive Right;Patent Portfolio;Patent Invalid;Pre-Clinical Test;Clinical Trial
|Issue Date:||2016-08-31 17:10:18 (UTC+8)|
The high-end advanced medical devices (abbreviated as advanced MDD) have shown considerable global market potential for growth. To make inroads into global MDD market, our government approved and implemented 'Biotech Take-Off Diamond Plan' to compete for this market, and has created more employment opportunities for high-quality personnel since 2009. Nevertheless, MDD protected by patents still cannot engage in profit seeking if it is not approved for marketing, and MDD without patent protection the market profit will be stroke down by the competitor launching of a similar product. The regulatory requirements of patent application and pre-market registration are competing for priorities and resources. This report analyzes the impact of pertinent laws and regulations on research and development (R&D) of the high-end MDD in Taiwan for use by the interested investors in their investment appraisal model. First, the procedure and characteristics of MDD R&D are briefly introduced. Second, ”Magnetic Resonance Image-Guided Ultrasound System” is used as an example of MDD to show case of its international R&D effort, clinical trial, market development, and compliance to its related international regulations. Lastly, the main regulations on manufacture, clinical trial, patent, and the competing regulatory requirements that high-end MDD investors might encounter are provided and analyzed. The analyses suggest the following for the interested investors in the high-end MDD: First, the latest point of entry of investment would be right before applying the permission of conducting the mandatory large-scale ”clinical trial” for MDD; second, need to hire a team of experts to evaluate the research documents on pre-clinical tests, other related experiments and/or trials, and the plan of filing patent (s) applications; third, not applying patent (s) of MDD before conducting clinical trial would result in significant risk of patent invalid; fourth, prepare to fund the mandatory cost of conducting clinical trial (s) and the liability insurance for its potential harm to the volunteering test subject; fifth, carefully evaluate the difficulty of passing pre-market registration hurdles caused by the indication for use of the MDD; sixth, have ready a medical device manufacturer conforming to the internationally recognized Quality System or having Good Manufacture Product certification from the future market country authority; seventh, decide the proper order of the application for specific market registration over the world to take advantages of potential abbreviated regulatory market paths.
|Relation:||政大智慧財產評論, 9(2), 99-135|
NCCU Intellectual Property Review
|Appears in Collections:||[智慧財產評論] 期刊論文|
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