Imported
products
(2) Comprehensive Review Mechanisms for the Registration of Medical Devices a. Recognized Standards and Product Guidances for Medical Devices
To improve the quality of medical device reviews and shorten review time, TFDA adopted recognized international standards on medical devices and developed product technical guidance documents on medical devices. As of the end of 2015, TFDA had recognized a total of 918 international standards on medical devices and 90 medical device product guidances from the U.S. Food and Drug Administration (FDA), as well as announced 50 product technical guidances on medical devices.
b. Optimization Measures for Review Processes of Medical Device Registration
Since November 2015, a pilot run of a 2-phase administrative and technical review system was initiated for the registration of Class 2 and Class 3 (medium and high risk) medical devices.
Upon receiving an application, the TFDA will complete a preliminary screening of administrative documents within 10 days before initiating expedited review of technical data to optimize the review process. In 2015, a total of 5,321 medical device registration reviews were completed, including 123 innovative medical devices with no similar products. This was a 9% increase (113 applications) compared to 2014, improving public accessibility and utilization of emerging medical devices in Taiwan.
Proportion for the number of valid licenses of domestic and imported medical devices in 2015 Figure 2-4-2
51 Average number of review days for clinical
trial applications throughout the years
(3) Establishing a Quality Environment for Medical Device Clinical Trial Regulations a. In 2015, TFDA promulgated the Good Clinical
Practice for Medical Devices (GCP) that was harmonized with ISO 14155:2011 and revised the Application Notes for Medical Device Clinical Trial Protocols, providing a reference for manufacturers and hospitals intending to conduct clinical trials of medical devices.
b. In 2015, a total of 74 clinical trial application reviews were completed. The average number of review days was 34, which was a significant reduction by 37% compared to 54 days in 2012 (Figure 2-4-3).
0 5
101 102 103 104 (year)
(days)
(4) Comprehensive Regulatory Counseling Mechanism for the Industry
a. In response to the development boom of the medical device industry in Taiwan, and to encourage the research and development of innovative medical devices, TFDA established a comprehensive regulatory inquiry and consultation network, strengthened the seamless three-step counseling mechanism, and actively seeking out high-end innovative medical devices with promising potential to provide them with consultation (Figure 2-4-4).
Comprehensive regulatory consultation network for medical devices Comprehensive Regulatory
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b. Outcomes of the Regulatory Inquiry and Consultation for the Industry
As of December 2015, a total of 16 domestically manufactured medical devices were approved for marketing, 10 were approved for clinical trials, and five outcomes of R&D efforts were successfully transferred to the industry. This included the world' s first clinical trial for high level treatment of cartilage defect, the world's first portable negative pressure wound therapy (NPWT) system, computer-aided ultrasound diagnostic system for thyroid glands, and the approval for marketing of Taiwan's first domestically manufactured bio-tissue adhesive.
c. Expanding the Medical Device Inquiry and Consultation Center
A total of six helplines for medical device inquiry (with four dedicated personnel and two voice message lines) were established. The helplines received a total of 19,926 incoming calls in 2015, which were 3,650 more calls compared to 2014. TFDA also worked with the Biomedical Science Park and provided four inquiry and consultation sessions to companies within the park.
d. Training Seed Regulatory Personnel
In 2015, seed personnel were newly recruited from units in the centers of industry-academia partnerships, innovation & incubation, and medical device research & development. After the annual training and assessment, there were 45 qualified seed personnel and 11 reserved seed personnel who were announced publicly on the TFDA website, allowing external parties to contact them for inquiry services.
Section 2. Medical Devices Source Management
Current Status
To ensure the stable production and management of medical devices are maintained, a source management system for medical devices has been enforced in Taiwan in order to supervise the quality management system and support product quality improvements of medical device manufacturers. A systematic management to align with international GMP regulatory mechanisms for medical devices were also employed to improve the competitiveness of the medical device industry in Taiwan and allow the industry to export their products to the international market. Through a two-track system of on-site audit and quality system documentation review for medical device manufacturers, objectives of source management would thereby be achieved.
Policies and Outcomes
1. Enhancing the Consistency of Inspections Carried out by Auditing Organizations
There are four GMP auditing organizations for medical devices in Taiwan, including the Center for Measurement Standards of the Industrial Technology Research Institute (ITRI), Taiwan Electronics Testing Center (ETC), Metal Industries Research Development Centre (MIRDC), and Plastics Industry Development Center (PIDC). In 2015, a Quality and Competence Improvement Program for Medical Device Inspection was carried out to review case studies of inspection processes and suspect issues in order to ensure that the inspection results are traceable to a consistent standard and ensure that relevant systems, regulations, and criteria employed in factory audits are harmonized with international standards. Guidelines for Commissioning GMP Certification of Medical Devices (Draft) were also developed which stipulated responsibilities, competences, experiences, and training required for auditing organizations and personnel commissioned to conduct GMP certification processes.
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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.
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 were issued (as shown in Figure 2-4-1).
Number of valid GMP/QSD registration letters for medical devices Table2-4-1
Year Number of valid GMP/QSD registration letters for medical devices 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
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2. Joint Post-market Audit of Medical Devices
To effectively supervise the compliance of package labeling of marketed medical devices with the approved documentation and to enforce provisions of Article 75 of the Pharmaceutical Affairs Act, TFDA selected four medical devices that had high potential for violations, high risks, and were targets of major public concerns, and worked with local health bureaus to conduct joint audits for 1,737 devices. A total of 50 violations (for a violation rate of 2.9%) were found, with the primary form of violation being labeling and package insert contents that failed to conform with the provisions of the Pharmaceutical Affairs Act. Violative products had been handled by regional jurisdictions in accordance with law (Table 2-4-3).
Section 4. Medical Device Safety Management
Current Status
To establish a comprehensive post-market safety surveillance system, TFDA established an adverse device reaction (ADR) reporting system to receive feedback and alerts from users, actively monitored safety alerts and information in Taiwan and other countries, enhanced post-market distribution management, and improved awareness of relevant regulations and policies (Figure 2-4-5). Effective quality surveillance systems have been employed to quickly acquire product safety alerts and facilitate timely handling, corrective and preventive measures, implementation of risk control and risk communication by regulatory agencies for achieving effective management.
Note: a: As the audits were carried out in different schedules, a number of counties, cities, or stores/street vendors may have been audited twice.
Results of quality surveillance for medical devices in 2015
Name of Project Total cases
Inspection Items
Survey on the Quality of Non-Invasive
Sphygmomanometers in Taiwan 18 18 0 18 0
Sterility Surveillance of Peritoneal Dialysis Catheters and Hemodialysis
Catheters in Taiwan 28 28 0 19 9
Total number of medical devices
(percentage) 46
Statistical analysis of joint audit results of medical devices in 2015