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Food and Drug Administration


c. Post-market Surveillance of Medical Devices

TFDA refers to the

Operation Directions for Product Post-market Surveillance

, promulgated on 15 April

2010, as well as adverse incident reports and alerts when deciding whether or not to include potentially

hazardous and high risk medical devices in the annual quality surveillance. In 2014, a total of 207

products were inspected, of which 11 products were found to be nonconforming (a nonconformity rate

of 5.3%). All these products have been transferred to the responsible health bureaus for subsequent

investigations and penalties.

(2) Risk Assessment Mechanism and Control

a. Medical Device Safety Assessments

To effectively monitor the medical devices used in clinic, establishment of a comprehensive medical

device risk management policy is necessary.Post-market safety assessments was initiated when

receiving the aforementioned adverse reaction reports, defective product reports, expiration of

surveillance periods, safety alerts, or safety concerns found for medical devices. Relevant domestic

and global medical device safety information is also collected. A Medical Device Safety Evaluation

Consultation Committee conducts risk assessment of the safety and effectiveness in clinical use

for marketed medical devices, and formulates risk control measures such as revision of package

inserts, conducting unannounced site visits, extending safety monitoring periods of medical devices,

or disseminating risk information from medical device evaluations. TFDA held two safety evaluation

consultation committee meetings in 2014.

b. Quality Surveys for Medical Devices

The risk level of defective medical devices is classified according to their hazard levels. According

to which, companies holding license permits are reminded every quarter to abide by the Good

Manufacturing Practice (GMP) for medical devices, conduct root causes analysis for quality

nonconformities, and submit preventive and corrective actions.

c. Risk Management for Medical Devices

In 2014, TFDA initiated measures for medical devices of safety and quality concern based on the

results of medical device safety evaluations and quality inspections. A total of 11 medical devices were

prioritized for site visits and GMP/QSD document reviews. Among these, the monitoring period was

extended for one medical device, revisions to the package inserts were asked for two medical devices,

while additional information was requested for five medical devices. Regarding medical device safety

and quality alerts, a total of 93 medical device alerts were published on relevant websites in 2014.

Abstracts and summaries were also emailed to the contact windows of hospitals to improve risk

awareness of medical staff and personnel as well as to enhance domestic communication of medical

device usage safety.

(3) Training for Risk Assessment Professionals

TFDA has continued to hold seminars on the Medical Device ADR Reporting System for medical

institutions, manufacturers, and general public while advocating relevant management rules related to the

Regulations for the Reporting of Serious Adverse Reactions of Medicaments.

A total of four such seminars

was held in 2014 which were attended by about 300 individuals. The seminars provided instructions on

the means of operating the reporting system to improve user willingness to report adverse reactions as

well as increase the number of reports.