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2015 Annual Report

49

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Food

Management

Medicinal

Products

Management

Policy and

Organization

Controlled

Drugs

Management

Medical

Devices

Management

apply for on-site inspections of overseas manufacturing factories. By the end of 2014, there were

565 valid registration letters for domestic medical device GMP, and 3,057 registration letters for

imported medical device QSD (Table 5-1).

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 in order to conduct the product quality monitoring plan. Post-market

quality surveillance is carried out by sampling marketed products offered in various drugstores,

pharmacies, medical device vendors, manufacturers or agents and subject them to quality

inspections.

Policies and Outcomes

1. Post-market Quality Surveillance of Medical Devices

Based on medical device management policy as well as items with higher nonconformities found

during post-market surveillance program, and adverse medical device reaction (ADR) reports, or

other risk assessment factors, TFDA carries out nationwide sampling inspections. In 2014, a total

of 216 items were sampled and subjected to quality testing as well as package labeling checks. Of

which, 205 items passed quality testing (qualified rate is 94.9%), and 129 items passed package

labeling checks (qualified rate is 59.7%). Nonconforming products were officially reported to the

local health bureau responsible for further administrative handling according to Pharmaceutical

Affairs Act. Results of various quality surveillance projects are shown in Table 5-2.

2. Joint Post-market Audit of Medical Devices

In order to effectively supervise the compliance of package labeling of marketed medical device

products, TFDA has provided support to local health bureaus by conducting joint medical device

audits. In 2014, a total of four medical device product categories were targeted for joint audits

due to their high rates of violation, risks, public scrutiny, and public sentiment. A total of 140 items

were audited, with 25 found to be nonconforming, a nonconforming rate of 17.9%. Major types of

violations included labeling and package inserts that violate the

Pharmaceutical Affairs Act.

Every

pharmaceutical company that committed package labeling violations for the medical devices has

been handled according to law by the local health bureau that exercise jurisdiction over them (Table

5-3).

Year

Number of vaild registration letters for medical device GMP / QSD

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

Table 5-1

Number of valid registrations for medical device GMP / QSD