From June 1,the modified Medical EquipmentSupervision and Management Regulations are officially in force. This isChina’s first modification on the Medical Equipment Supervision and ManagementRegulations during the past 14 years. This means that the supervision andmanagement of medical device and its market running have entered the new stage.
The publicdata indicate that, in China, the number of medical device manufacturingenterprises is over 15,000 and according to the statistics in 2013, outputvalue exceeds 2 trillion yuan. From spatula to heart stent and CT detectors,medical device has become an industry with numerous and jumbled sub-categories,multiple enterprises, and a rapid growth in industrial value.
The rapiddevelopment of the industry poses a challenge to the supervision andmanagement, and the original regulations have always been the object ofcriticism.
From earlyMarch this year, supervision and management departments have organized a seriesof activities in managing medical devices. First, China Food & DrugAdministration modified the new supervision and management regulations; then,this department gave wide publicity to the remediation campaign in five aspectsof medical devices and subsequently carried out the long-distance march ofmedical device, and finally launched the QualitySupervision and Management Methods for Medical Device Use (Exposure Draft).
As for themodified regulations, there are always people who stand up to question theslackening in the supervision and management. However, actually, this is achange in the supervision and management idea, and the supervision andmanagement of medical device changes from the emphasis on the beforehand supervisionand management to the emphasis on the process supervision and management.
This changeis embodied on the production, operation and post-marketing monitoring, and thepunishment of all links. The manufacturing enterprises need to submitself-inspection reports to the supervision and management departments; theoperating enterprises and the use units should verify its goods-supplyqualifications and product credentials, and make proper records; add themedical device adverse event monitoring system, registered medical devicere-evaluation system, and medical device recall system; as for the productionand operation activities carried out without the authorization, a fine as highas 20 times of the goods value can be charged.
Productionis production; registration is registration.
Incomparison with the Medical Equipment Supervision and Management Regulationsdrawn up in 2000, what is the most eye-catching in the modified new regulationsis the relation between permission and registration.
According tothe 2000 version of Medical Equipment Supervision and Management Regulations,China executes the product manufacturing and registration system on medicaldevices. The registration system divides the medical devices according the riskdegree of the medical devices produced by the enterprises. Simply put,municipal drug supervision management departments verify and issue the productionregistration certificate to class I medical devices with the lowest risk,provincial drug supervision management departments verify and issue theproduction registration certificate to class II medical devices with the lowestrisk, and the State of Council drug supervision management department verifyand issue the production registration certificate to class III medical deviceswith the lowest risk.
Issuance time: 2014 Source: China Youth Daily
