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Co.Ltd. | Ref : | QP-001-024 |
Version: | C0 |
Page(s)marchon | 1st of 7 |
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The Medical Device Vigilance System
1.Purpo
The principal purpo of the Medical Device Vigilance System (Hereinafter referred as the ‘System’) is to improve the protection of health and safety of patients, urs and others by reducing the likelihood of reoccurrence of the incident elwhere. This is to be achieved by the evaluation of reported incidents and, where appropriate, dismination of information, which could be ud to prevent such repetitions, or to alleviate the conquences of such incidents.
prent怎么读2.Scope
The ‘System’ applies to incidents with regard to:
2.1 devices which carry the CE-mark (Hereinafter short for ‘CE products’) within EU
2.2 devices that do not carry the CE-mark but where such incidents lead to responsibilities of corrective action(s), medical incident(s) and report(s) within EU relevant to ‘CE products’ mentioned above.
2.3 devices which carry the CE mark outside EU.
3．Responsibility
3.1 The Manufacturer’s Responsibilities: The Manufacturer shall start investigation once upon the incident notice is received, and find out the relationship among the responsible bodies, authorized EU reprentatives and their National Competent Authorities.
3.2 The Authorized EU Reprentatives’ Responsibilities: Once the incident notice is received, the authorized reprentatives within EU shall notify the Manufacturer immediately and assist him to deal with incidents, and meanwhile, submit to their National Competent Authorities the initial report, investigate outcome and the final report.
3.3 The Sellers or Distributors’ Responsibilities: The llers or/and distributors shall report customers’ complaints and submit incident reports to the Manufacturer timely, and keep the sales records.
4．Procedure
4.1 The management reprentative shall decide items to be reported to the local competent authorities after an analysis of incident report details, and joint investigation by biochemical and quality control departments.
4.2 When the Manufacturer decides whether the incident shall be notified to the competent authorities or not, the following factors shall be considered:
a)Incident type
密友是什么意思Medical Appliance Co., Ltd. | Ref: | QP-001-024 |
Version: | frank lucas 功夫熊猫台词C0 |
Page(s) | 2nd of 7 |
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b)Whether the incident is related to any medical device from the Manufacturer or not.
c)The possibility of whether the incident is caud by defects on medical devices or its information provided
4.3 The management reprentative shall inform competent authorities, when one or more of the following outcomes are included:
4.3.1 death of a patient, ur or other person.
4.3.2 rious deterioration in state of health of a patient, ur or other person.
德瑞姆心理咨询A rious deterioration in state of health can include:wormwood
a) life-threatening illness,
b) permanent impairment of a body function or permanent damage to a body structure,
c) a condition necessitating medical or surgical intervention to prevent a permanent impairment of a body function or structure.
4.3.3 The incidents with the possible outcomes of death or health deterioration, or defects detection of the medical devices. Such a incident is called ‘Potential Incident’.
4.4 In asssing the link between the device and the incident the Manufacturer should take account of:
the opinion, bad on available evidence, of healthcare professionals;
the results of the Manufacturer's own preliminary asssment of the incident;
evidence of previous, similar incidents;
other evidence held by the Manufacturer.
4.5 The incident report shall include the following contents:
4.5.1 Any malfunction or deterioration in the characteristics and/or performance of a device
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4.5.2 One of device characteristics has the possibility of resulting in an incident without any malfunction or its performance deterioration. In this ca, a ‘Potential Incident’ report shall be conducted.
4.5.3 Any inadequacy in the instructions for u which might lead to or might have led to the death of a patient or ur or a rious deterioration in his state of health;
4.6 The Incident Report Timescale
After receiving the incident notice and completing the preliminary asssing report by the management reprentative, the Manufacturer shall inform the competent authorities within timescale as follows:
