Platelet storage systems 9 73 16 5 31.2
Transcutaneous electrical nerve stimulators, facial transcutaneous electrical stimulators, ultrasound therapy devices
9 73 70 2 2.9
Powered heating pads 9 73 67 5 7.5
Blood pressure meters 21 370 985 24 2.4
Blood glucose meters (including
blood glucose test strips) 21 370 599 14 2.3
Total 69a 443 1,737 50 2.9
Table2-4-3
55 Policies and Outcomes
1. Strengthening Post-market Safety Monitoring of Medical Devices (1) Active Monitoring of Domestic and Global Medical Device Safety Alerts
a. In 2015, a total of 375 adverse reactions, 3,453 defective medical devices, 178 adverse events in clinical trials, and 138 periodic safety update reports were uploaded to the Post-market Quality Management System for Food, Drugs, and Cosmetics. These cases have underwent data normalization as well as subsequent analysis and evaluation.
b. In 2015, a total of 1,936 domestic and global safety alerts were actively monitored, including 715 product alerts and 1,221 recall notifications. TFDA selected a total of 136 medical device user safety messages concerning the domestic public, and translated them into summaries for announcement.
(2) Joining the Global Vigilance Report Exchange System
The TFDA is a member of the Safety Alert Dissemination System (SADS) of the Asian Harmonization Working Party (AHWP), which allows access to safety alerts and recalls that are announced internationally. In 2015, a total of 1,416 messages were received. After evaluation, it was revealed that 510 of these messages were related to Taiwan, whereupon notifications were immediately released to the relevant businesses to initiate response measures.
(3) Improving ADR and Defective Product Reporting for Medical Devices
In addition to organizing continuous awareness programs and seminars to better motivate medical institutions, manufacturers, and members of the public to report adverse reactions and defective products, TFDA also established a program in 2015 to support seed hospitals in establishing internal ADR reporting mechanisms. Personnel relevant to the notification process underwent training to improve the number and quality of ADR reports. The number of ADR reports rose from 30 in 2009 to 375 in 2015, while the number of defective product reports rose from 157 to 3,453 (Figure 2-4-6).
Safety
and joint audits Active monitoring of domestic and global medical device quality alerts
Reporting System Medical Device Safety Monitoring
(with Periodic Safety Update Report, PSUR)
Post-market risk control mechanism of medical devices Figure 2-4-5
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(4) Suspension of GMP & QSD Certification
To ensure the quality of medical devices, a phased process for reviewing expired GMP/
QSD registration letters were completed in 2015. The review resulted in suspension of 303 medical device licenses relating to 133 pharmaceutical firms. These companies were notified to have their manufacturers re-apply for medicament manufacturing licenses (the GMP/QSD registration letters), or apply for changes to their medical device manufacturing licenses by switching to other manufacturers that have already acquired medicament manufacturing licenses before they can continue the production or import of relevant products.
2. Pharmaceutical Firm and Product Distribution Management
(1) Expanding the Types of Some Class 2 Medical Devices that Can be Sold Online
Revisions to the Registration Requirements of Mail-Order Purchase for Medical Devices were promulgated on October 15, 2015, allowing the online sales of 8 items of medium risk Class 2 medical devices, including surgical mask, alcohol pad, providone-iodine pad, vaseline gauze, adhesive bandage, contact lens cleaning and care product, and picture archiving and communication system.
(2) Strengthening Post-market Regulation of Class 1 Medical Devices
The regulation of Class 1 medical devices makes reference to the listing method employed by advanced countries in the Europe and U.S., where suppliers complete an application form and declare that products conform to the scope identified with Class 1 medical devices. Their approved functions shall be restricted to the scope identified in the device category and classification. However, incidents of errors in supplier declarations have occasionally been found. To strengthen the postmarket regulation of Class 1 medical devices, TFDA initiated a Class 1 license re-evaluation program in 2014. By 2015, a total of 36 licenses were found to have stated functions that did not conform to the scope identified in the original declaration.
These licenses had all been revoked accordingly.
Defective product / ADR reports of medical devices 0
500 157 366
748
1,368
1,634
1,401
3,453
30 54 70 144 209 375
85 1,000
1,500 2,000 2,500 3,000 3,500 4,000
Number of ADR reports Number of defective products ( Year ) ( Number )
98 99 100 101 102 103 104
Figure 2-4-6
57 (3) Promoting Good Distribution Practice (GDP) for Medical Devices
To ensure that medical device importers, dealers, or pharmacies are capable of maintaining product quality specified by the original manufacturer during transport and sales activities, the TFDA began implementing regulatory measures for the distribution of medical devices starting in 2014 and promulgated the Good Distribution Practice (GDP) for Medical Devices on June 18, 2015. As of the end of 2015, TFDA organized six training seminars and two outcome presentation seminars, and completed consultation visits to 35 medical device vendors.
(4) Implementing the Unique Device Identification (UDI) System
The three issuing agencies and their coding specifications (GS1/GS1-128, HIBBC/HIBC, ICCBBA/ISBT 128) recommended by the International Medical Device Regulators Forum (IMDRF) and U.S. FDA were adopted by TFDA to promulgate the Unique Device Identification (UDI) System Regulation on October 30, 2015. This would allow both importers and domestic manufacturers to adopt globally recognized UDI coding and barcode specifications for medical devices in establishing the basis for automated distribution management.
3. Strengthening Awareness of Medical Device Regulatory Policies (1) Promotion of Key Policies
In 2015, TFDA organized about 30 promotional activities that included training sessions and seminars for Good Distribution Practice (GDP) of medical devices, introduction and use of the UDI system, medical device GCP inspection workshop and regulation revisions, medical device clinical trial IRB forums and symposiums, medical device adverse event analysis and management, for enforcing the implementation of various key policies.
(2) Enhancing Communication With Medical Institutions
To help medical institution personnel acquire an effective understanding of the causes for ADRs as well as user experiences of medical devices, and to gain familiarity with proper handling methods, procedures, and government regulatory practices, TFDA held education and training courses at six medical institutions in northern, central, and southern Taiwan in 2015. The courses targeted non-ideal situations primarily during the process of operating medical devices in local medical institutions, such as failure to perform, malfunction, or anomalies of medical devices, and allowed for information exchanges and sharing of experiences.
(3) Establishing a Communication Platform for Industry Associations
In 2015, TFDA held two communication meetings with industry associations of medical devices. The platform allowed direct dialogue with the industry in order to achieve a mutually beneficial consensus over relevant policies and facilitate the promotion and implementation of future policies.
(4) Strengthening Regulatory Knowledge and Capacity for Medical Devices amongst Academic Research Institutions
TFDA held three seminars promoting awareness of medical device regulations in various universities, colleges, and medical engineering institutions, with the hope that the academia and industry may promptly apply regulatory concepts pertaining to medical devices in the initial phases of research and development (R&D) in order to shorten R&D cycle time and costs and to commercialize the R&D outcomes as early as possible.
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