The construction, policies and development suggestions of the regulatory framework of medical device

The medical device industry belongs to the field of knowledge-intensive science and technology manufacturing. Product research and development and production involve multiple professions such as machinery, electronics, and polymer materials. Its complexity and diversity have put forward higher and higher requirements for the standardization and scientific nature of regulatory work. At present, my country's medical and health industry is developing rapidly, the public's demand for medical device products is increasing, and the requirements for product quality are also constantly improving. Adjustments to the medical device regulatory methods will have a direct impact on the industry and public health. The promulgation and implementation of the "Medical Device Supervision and Administration Regulations" and related normative documents have promoted the development of my country's medical device industry. At the same time, the rapid development of the medical device industry has also put forward new requirements for regulatory work. This article analyzes the impact of medical device regulatory laws and regulations on the development of the medical device industry, and puts forward reasonable suggestions for actual regulatory work, aiming to promote the better development of the medical device industry.


Construction of medical device regulatory system


The implementation of the 2000 version of the "Medical Device Supervision and Administration Regulations" has played a positive role in the development of the entire medical device industry. However, with the rapid development of the medical device industry, the relevant content cannot meet the development needs of the industry. In 2006, the revision of the "Medical Device Supervision and Administration Regulations" (2000 version) was launched, and public opinions were solicited in 2007 and 2010, and it was revised and passed and promulgated in 2014.