Recently, the General Office of State Council printed and issued Guiding Opinions on Promoting Healthy Development of Medical Industry (hereinafter referred to as the Guiding Opinions), which explicitly proposes to encourage and develop the medical equipment third party professional maintenance, after-sale service team.

Encourage to construct third party quality reliability assessment platform

 (V) Accelerate quality upgrading, promote green and safe development. (Excerpts)

Accelerate the improvement of public technical service platform as metering, standard, test, certification authentication, etc., encourage to construct third party quality reliability assessment platform, promote enterprise to increase input and improve product reliability.

Break original factory monopoly, encourage to develop third party maintenance, after-sale service team

 (VII) Develop modern logistics, construct medical credit system. (Excerpts)
Promote the establishment of source code opening system in the link of medical equipment communication protocol, failure feedback, test and maintenance, etc., encourage to develop third party professional maintenance, after-sale service team.

Strengthen management in the use of medical device

 (XVI) Strengthen industrial collaborative supervision and administration. Improve regulatory department, industrial association, medical enterprise communication mechanism, improve horizontal and vertical fully stretched supervision and administration network and form the supervision and administration situation of common control by all society. Support social group as industrial association, etc. to conduct industrial operation monitoring analysis, industrial development strategy research and industrial information release. Strengthen management in the use of drug and medical device, strengthen adverse drug reaction monitoring, implement the main body responsibility for adverse reaction after the product is listed. Improve safety assessment working mechanism after the drug is listed, establish drug delisting system. Establish clinical drug comprehensive assessment system that focuses on basic drug, improve drug short supply early warning mechanism, dynamically master the production situation of key enterprise, improve supply guarantee capacity and level. Strengthen construction of legal system for drug and medical device supervision and administration, strengthen flying inspection, investigate and punish illegal enterprise in time. Strictly supervise and manage safety, environmental protection, firmly close nonconforming pharmaceutical enterprise according to law. (Excerpts)

The issue of the Guiding Opinions further enriches the supporting bylaw system of Medical Device Quality Supervision and Administration Measures of China Food and Drug Administration. The insiders believe that with the vigorous development of medical equipment, coupled with the national policy guide, after-sale third party agent will face broad market space.