||Biotechnology-related industry has been recognized as the most potential business in twenty-first century. The next step of Taiwan's high technology should focus on the invention and innovation-based industry, which biotechnology should be included. Medical technology is a high value-added, application-board industry. To enhance its competitiveness and speed up access to international markets, producers need to ensure the product quality, strengthen the international management, conformity the regulation in all different countries. At present, the relevant laws and regulations of pharmaceutical products include the followings: the Pharmaceutical Affairs Law, good manufacturing practice of medical device (GMP), pharmaceutical Good Manufacturing Practices (cGMP) and the rapid development of cell therapy and the management of human cells and tissues (Good Tissue Practice, GTP) .