Page 55 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

2. Registration Management of Medical Device Manufacturers
Before a medical device can be placed on the market, the quality system of its manufacturer
must comply with Taiwan’s medical device GMP standard.
Medical device importers can apply for compliance with Taiwan’s Quality System
Documentation (QSD) requirement, or apply for on-site audits for overseas medical device
manufacturers. For medical device manufacturers located in Taiwan, on-site audits will be the
primary means of inspection.
By the end of 2015, a total of 685 valid GMP registration letters for domestic medical device
manufacturers were issued, while 3,640 QSD registration letters for imported medical devices Part II - Key Administrative Results Medical Devices Management
were issued (as shown in Figure 2-4-1).

Table2-4-1 Number of valid GMP/QSD registration letters for medical devices

Number of valid GMP/QSD registration letters for medical devices
Year
Valid GMP registration letters Valid QSD registration letters
2010 236 1,340
2011 486 2,777
2012 531 3,065
2013 568 3,213
2014 565 3,057

2015 685 3,640

Section 3. Medical Device Quality Chain Monitoring

Current Status
Risk assessment mechanisms are used every year to target specified items. Resources
from local health bureaus are integrated to carry out medical device quality monitoring plans.
Post-market quality surveillance is carried out through quality sampling and testing of marketed
products from drugstores, pharmacies, medical device vendors, manufacturers or agents.
Policies and Outcomes

1. Post-marketing Quality Surveillance of Medical Devices
Reports and alerts of adverse events of medical devices and other related information are
used as a reference to identify medical devices with high potential risks and high levels of
hazards and include them in the quality surveillance. In 2015, a total of 46 items were sampled
and underwent quality and package labeling checks. All items were found to be compliant
with quality checks, while 37 were compliant with package labeling checks (conformity rate
of 80.4%). The nine nonconforming products were officially reported to the responsible local
health bureaus for handling in accordance with law. Table 2-4-2 shows the results of various
surveillance programs.

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