A medical device is any apparatus, appliance, software, material, or other article – whether used alone or in combination for human beings, thereby serving the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease. Hence the medical devices industry plays a critical role in transforming the standard of care and improving the quality of life for millions of patients across the globe.
This capacity of medical devices to enable patients to survive or just improve their quality of life in the absence of a cure will continue to grow as multiple scientific disciplines (biomaterials research, cell biology, information technologies, etc.) individually make advances and complement each other in medical device design.
In order to provide the same benefits to the citizens of Taiwan, the member companies of the AmCham Taipei Medical Device Committee have always been at the forefront in introducing cutting-edge technology products and services. Since the field is very dynamic, it is imperative to facilitate the speedy launch of these devices for improving the quality of life for patients. To achieve these objectives, we consider it critical to streamline the registration process and to create an environment in which pricing and reimbursement policies are consistent, stable, and beneficial for all concerned. We hope that all key stakeholders in Taiwan will work closely together toward that goal.
Following are our specific recommendations:
Suggestion 1: Accelerate the pre-market approval process.
1.1 Accept the Medical Device Single Audit Program (MDSAP) audit report as a substitute for the current FDA EIR module under the QSD-simplification approach.
Submission of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) is one of the essential requirements under Taiwan’s simplified Quality System Documentation (QSD) approach for auditing manufacturing sites located in the United States. The Committee suggests that the Taiwan Food and Drug Administration (TFDA) take note of an alternative auditing approach – the Medical Device Single Audit Program (MDSAP) developed by IMDRF (the International Medical Device Regulators Forum). Since 2016, the U.S. FDA has recognized MDSAP audit reports as a substitute for EIRs. Besides the U.S. FDA, other global authorities participating in MDSAP include Australia’s Therapeutic Goods Administration, Brazil’s ANVISA, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency. The MDSAP audit report is recognized by each participating authority as an official audit report.
Considering this global trend, the Committee suggests that TFDA also accept MDSAP audit reports as a substitute for the FDA’s EIR report in applications for treatment under the simplified QSD approach.
If TFDA can accept this suggestion, it will provide greater harmonization with global trends and enable Taiwan patients to gain earlier access to innovative medical devices.
1.2 Simplify the renewal requirements for QSD.
QSD has to be renewed every three years. Currently, the requirements for the initial and renewal applications are the same. To make the review process more efficient, the Committee suggests that except for major changes identified by the manufacturer as affecting product quality and/or manufacturing-related processes (e.g. line extensions and changes to the manufacturing flowchart), the entire QSD renewal requirements should be allowed to be met through a manufacturer’s letter accompanied by the latest version of the master documentation list (including tier-1 and tier-2 standard operating procedures). The result will be to significantly reduce the reviewing time for the benefit of both the applicant and the TFDA. As usual, the manufacturer would be responsible for maintaining all quality-related documents/ records in a well-managed and controlled manner, and all quality documents would be available to be inspected/ reviewed by the TFDA when needed.
Suggestion 2: Outline the policy direction and NHIbudget for new medical technology in a forward lookingand comprehensive manner.
The government’s policies and direction in health enhancement in different disease areas, the priorities assigned to medical resource allocation, and the budgeting of new medical technology under the Global Budget System are all factors influencing the application and development of medical science and technology. A forward-looking policymaking approach can guide the industry to properly introduce new medical devices and technologies, align with the government’s plans for medical resource allocation, and help create a better medical environment to achieve a win-win-win result for the government, the public, and the medical industry. The Committee recommends the following:
2.1 Systematically plan sufficient NHIA budget for new medical services and new medical devices and utilize the budgets flexibly.
Along with the establishment of a reimbursement tracking system for new medical services and devices, this approach would enable the National Health Insurance Administration (NHIA) to plan for new medical technology reimbursement and healthcare resource allocation in a more integrated manner to ensure the continuity in the introduction of new medical technology.
2.2 Provide forward-looking enhancement directions in different diseases areas and prioritize the allocation of emerging medical science and technology resources.
Remote monitoring systems are an example of an emerging medical technology that has been widely used in post-acute care, treatment of chronic diseases, and home care. Given the rapid aging of the Taiwan population, the application of these technologies has become increasingly important, at the same time as the technologies have become more and more mature. For example, remote monitoring systems can improve the frequency of medical visits and lower medical expenses for chronic heart failure patients, and support disease management and enhance medication compliance for patients with diabetes or end-stage renal disease (ESRD). NHIA should devise concrete plans to encourage improvements in the efficiency of the healthcare system through application of the remote healthcare model and medical devices with remote monitoring functions.
Suggestion 3: Further improve the price/volume survey mechanism.
We appreciate NHIA’s adoption of the Committee’s recommendations on ways to improve the price/volume survey mechanism and set a floor price for low-priced special materials (the industry term for medical devices eligible for reimbursement). The NHI reimbursement principle for medical devices is based on the product’s functionality, with all devices performing the same function reimbursed at the same price. The reimbursement tariff is calculated on the basis of “points” rather than “fees.” After years of price/volume surveys and price adjustments, the market prices among different brands of products in some functional categories have been brought down to a common level.
The Committee therefore recommends continued review of the price/volume survey for special materials, including establishment of a stop-loss mechanism to exempt products from further price/volume surveys after they have undergone several rounds of surveys and subsequent substantial price cuts. Adopting this mechanism would contribute to streamlining the surveys’ operations. It would also help prevent situations in which newly marketed special materials identified by NHIA as belonging to existing functional categories are unable to be listed because the reimbursement prices in those functional categories have reached such a low level. If special materials with functional improvements are faced with reimbursement prices far below international prices, the impact would be negative not only for manufacturers but also for Taiwanese patients’ access to innovative devices. For innovative devices, a premium pricing rule should be applied.
1.1接受醫療器材單一稽核計畫(Medical Device Single Audit Program, MDSAP) 稽核報告可替代醫療器材優良製造規範簡化模式之美國食品藥物管理署所出具之查廠報告(EIR)
美國食品藥物管理署(以下簡稱FDA)所出具之查廠報告(以下簡稱EIR) 係“醫療器材優良製造規範美國廠簡化模式”必要文件之一，而FDA於2016年發表書面聲明認同醫療器材單一稽核計畫(Medical Device Single Audit Program, MDSAP)之稽查報告與EIR具有相同效力。國際醫療器材法規論壇IMDRF (International Medical Device Regulators Forum) 所提出之醫療器材單一稽核計畫(MDSAP)，除美國食品藥物管理署外，尚有澳洲最高衛生主管機關 Therapeutic Goods Administration、巴西最高衛生主管機關ANVISA、加拿大最高衛生主管機關Health Canada及日本最高衛生主管機關Ministry of Health, Labour and Welfare與日本 Japanese Pharmaceuticals and Medical Devices Agency皆加入此計畫並認可MDSAP之稽查報告可視為官方正式查廠報告。