Eligibility eased for high-risk medical device incentives
- Date:2010/7/16
- Data Source:Executive Yuan
The government hopes that the biotech and new pharmaceuticals industry can be developed into a locomotive force for economic transition, and the Executive Yuan has given its approval to a revision of Article 3 of the Act for the Development of Biotech and New Pharmaceuticals Industry that lowers the threshold of applicability for preferences for high-risk medical devices and encourages companies to become involved in the biotech industry.Under the current provisions of the Act for the Development of Biotech and New Pharmaceuticals Industry, high-risk medical devices must conform to the definition of “Class III medical devices that are implantable into the human body” to be eligible for shareholder investment tax credits and tax offsets of up to 35% for R&D spending.The Ministry of Economic Affairs (MOEA) notes that high-risk medical devices must pass clinical testing, carry a high investment risk, and have a long development period. There are not many companies in Taiwan that engage in the development of Class III medical devices, and even fewer that are involved in medical devices that are implantable. Not very many, therefore, have been approved as high-risk medical device manufacturers since the Act for the Development of Biotech and New Pharmaceuticals Industry was implemented. In response to suggestions by manufacturers, and to encourage them to engage in the development of biomedical devices, the proposed revision deletes the requirement for medical devices to be “implantable”. The MOEA points out that the revision meets the practical needs of industry by expanding the list of applicable medical devices from the original 96 to 134. This will stimulate small and medium-sized precision machinery manufacturers with an advantage in high-level R&D to get involved in the biotech industry, and give further impetus to the development of high-risk medical devices.