CE医疗器械警戒系统(英文版)

The Medical Device Vigilance System

1. Purpose

The principal purpose of the Medical Device Vigilance System (Hereinafter referred as the ‘System ’) is to improve the protection of health and safety of patients, users and others by

reducing the likelihood of reoccurrence of the incident elsewhere. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents.

2. Scope

The ‘System’ applies to incidents with regard to:

2.1 devices which carry the CE-mark (Hereinafter short for ‘CE product s ’) 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 Responsibilit ies: The Manufacturer shall start investigation once upon the incident notice is received, and find out the relationship among the responsible bodies, authorized EU representatives and their National Competent Authorities.

3.2 The Authorized EU Representativ es’ Responsibilities: Once the incident notice is received, the authorized representatives 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 sellers 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 representative 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

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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 caused by defects on medical devices or its

information provided

4.3 The management representative shall inform competent authorities, when one or more of the following outcomes are included:

4.3.1 death of a patient, user or other person.

4.3.2 serious deterioration in state of health of a patient, user or other person.

A serious deterioration in state of health can include:

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 assessing the link between the device and the incident the Manufacturer should take account of:

the opinion, based on available evidence, of healthcare professionals;

the results of the Manufacturer's own preliminary assessment 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

4.5.2 One of device characteristics has the possibility of resulting in an incident without any malfunction or its performance deterioration. In this case, a ‘Potential Incident’report shall be conducted.

4.5.3 Any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or a serious deterioration in his state of health;

4.6 The Incident Report Timescale

After receiving the incident notice and completing the preliminary assessing report by the management representative, the Manufacturer shall inform the competent authorities within timescale as follows:

a）Incident: 10 days

b）Potential Incident：30 days

4.7 Competent Authorities on medical devices to be reported

4.7.1 If the incident occurs in EU, it shall be reported to local competent authorities.