Release date: 2009-02-18 ——Yang Yue Tang Han Ling Hu Changli Liu Dongxu translated
Health supplies:
refers to the use of people's lives, that have a regulation of human
function and promote health and other specific features of the supplies,
with the social and economic development, people's lifestyles are
constantly changing, treatment from prevention to start, so nutrition
and health Demand for goods is growing, there is a demand market.
Overall,
with the penetration of foreign health care products by counterparts
and foreign investment, the price cuts resulting from competition are
inevitable. The demand elasticity of health care products is relatively
large, and the marginal effect of price decline is obvious. Enterprises
can promote the increase in demand through price cuts And then occupy the market will be the main means of competition in the future.
However,
the trend of different product prices will be different, such as the
general consumer health care products, the price will go down; and for
high-end users of refined health care products, including health gifts,
including, with the packaging Grade and added value, the price will not only decline, there is a further upward trend.
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Five manufacturer role
(i) Manufacturer's reporting obligations
When a medical device event complies with the relevant reporting standards, the manufacturer or its authorized representative shall report the incident and site safety corrective actions to the relevant national authority. At the time of reporting, the manufacturer or its authorized representative shall submit an initial incident report to the national authority for the purpose of recording and evaluating the incident process. Each initial report should have a final report corresponding to it, unless the initial report and the final report are a report.
The manufacturer or its authorized representative shall have an upfront processing before submitting the medical device incident, that is, the right to decide whether to report it. In general, if a medical device event occurs outside the European Economic Area and outside of Switzerland, or occurs in these areas but does not require on-site safety corrective measures (FSCA), no reporting is required. If a medical device incident occurs outside the European Economic Area and outside of Switzerland, but does cause a Site Safety Corrective Action (FSCA) in these locations, it must be reported as an FSCA. In addition, the manufacturer should also notify its authorized representative, the person responsible for placing the device on the market, and other agents (such as distributors) to report the incident and FSCA under the medical device alert system when appropriate. The report cannot be improperly delayed due to insufficient information. If the manufacturer is outside the European Economic Area and outside Switzerland, the appropriate point of contact within the territory should be provided to report the medical device incident, which may be the authorized representative of the manufacturer, the person responsible for placing the device on the market or other agents.
(2) The standard for the manufacturer to report the incident to the competent authority
Any event that meets the following three reporting criteria can be considered a medical device event and must be reported to the relevant national authority. The specific criteria are as follows:
1. Medical device incidents have occurred, including information provided during testing of the device, inspection of the device, or inspection of any scientific information that may have caused or may have caused an event in the device.
Typical events include: (1) malfunction or destruction of the characteristics of the device, performance (failure or destruction can be understood as the operation of the device does not achieve the intended purpose when the device is used in accordance with the manufacturer's instructions); (2) excluded False positive or false negative test results outside the accepted test range; (3) Unexpected adverse reactions or side effects; (4) interaction with other substances or products; (5) degradation and destruction of the device (eg fire); 6) Improper treatment; (7) Labels, instructions for use or promotional materials are inaccurate, inaccurate, including missing or insufficient information, where missing information does not include information that users should be familiar with.
2. There is reason to believe that the manufacturer's equipment is one of the causes of the incident. Manufacturers should consider the relationship between devices and medical device events: (1) based on available evidence or opinions of Health Care professionals; (2) the results of the manufacturer's own initial evaluation of medical device events; (3) before Signs of similar medical device incidents; (4) Other evidence held by the manufacturer.
3. The medical device incident has caused or may have the following consequences. (1) The patient, the user, or other person dies; (2) The patient, the user, or other person has a severe deterioration in physical condition. Serious deterioration of physical condition includes: 1 life-threatening disease; 2 permanent damage to the body's function or permanent damage to the body's structure; 3 forced use of drugs or surgery to prevent 1 or 2 from happening. For example, clinically, the operation time is prolonged; there is a need to hospitalize or extend the length of the existing hospital stay. 4 Indirect injury caused by misdiagnosis or indirect injury according to the manufacturer's instructions; 5 fetal death, any congenital abnormalities or abnormal development.
It is worth noting that not all medical device events can lead to death or serious deterioration of the patient's condition, or it may be due to other favorable conditions or the intervention of health personnel.
(3) Conditions for periodic summary reports under the medical device alert system
After the manufacturer and national authority publishes and evaluates one or more initial reports, the national authority typically receives periodic summary or trend reports from the manufacturer or authorized representative. This periodic summary report is an agreement between the manufacturer and the national authority to report a specific type of activity in a certain format and frequency.
When the manufacturer receives notification of a periodic summary report or trend report approved by the national authority, the manufacturer shall inform the relevant national authorities of the contents of the agreement. Regular summary reports can only be transmitted to other competent authorities with the unanimous consent of their national authorities.
1. Description of the event specified in the on-site safety instructions
The incidents specified in the on-site safety instructions refer to events that occur after the manufacturer issues on-site safety instructions and takes safety corrective actions. Such incidents do not require a case report. However, manufacturers can regularly summarize the frequency and content of reports in consultation with national authorities, and periodic summary reports should be sent to all affected national authorities and relevant national authorities.
For example, the manufacturer issues on-site safety instructions and takes on-site safety corrective actions regarding the displacement of the coronary stent due to insufficient inflation of the attached balloon device. In this case, the case of stent displacement is based on the quarterly report of on-site safety corrective measures, and case events need not be reported.
2. Common and known events
Ordinary and known events (report reports that have been evaluated by the manufacturer and the relevant national authority) do not have to be reported to the national authorities and can be converted directly into a regular summary report. However, these events will be monitored by the relevant authorities to gradually determine the trigger level of the periodic summary report; the trigger level interval should also be approved by the relevant authorities. As long as the monitoring finds that the trigger level reaches a certain level, the manufacturer should report it in the interim. (China Medical News) - Shanghai Medical Device Industry Association
