For many years, the medical device industry has encountered Certificate to Foreign Government/Certificate of Free Sale (CFG/CFS)-related obstacles that hinder product registrations and even pose a barrier to trade. At times, the TFDA does not accept a CFG/CFS due to minor variations in the model codes given for the same product. These variations usually occur in an attempt to fulfill various country-specific requirements or to distinguish between models from different jurisdictions (for example, U.S. and EU). In addition, in certain countries of origin, the CFG/CFS issuance can be extraordinarily lengthy, and in some instances the CFG/CFS may or may not include certain models because of countries’ varying definitions of what constitutes the Legal Manufacturer, which may not necessarily be the Physical Manufacturer.

Moreover, a CFG/CFS only provides information on the manufacturer’s name, address, and product model codes. While names and addresses can be verified through the Quality Management System, information on product model codes is generally based on supplementary documents provided by the manufacturer (such as Letters of Authorization and technical documents) – and not solely based on the CFG/CFS.

Under the current Taiwan Medical Device Act, a CFG/CFS is not required when the product is novel and first-to-market in Taiwan, and when reports are presented from a locally conducted clinical trial and an on-site audit conducted by the TFDA. However, imported medical devices rarely meet these stringent requirements.

Most developed economies and APAC countries – including the U.S., Canada, the EU, Japan, Australia, Korea, Singapore, Malaysia, the Philippines, and Thailand – do not require a CFG/CFS for product registration. The only Asian markets still requiring a CFG/CFS for product registration are Taiwan, China, Cambodia, and Vietnam.

Maintaining the CFG/CFS requirement lengthens the time to market for innovative imported medical devices. Eliminating that requirement could accelerate the approval process for imported medical devices for the benefit of local patients and enable the early introduction of new technology to healthcare professionals. It would also bring Taiwan one step closer to regulatory harmonization with other markets.

Suggestion 3: Set fair reimbursement prices when re-reviewing products on the “non-reimbursed medical device list.”

Items on the “non-reimbursed medical device list,” which have been published following review by the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) committee, may be offered by hospitals as self-pay items, providing patients with the option to use new medical technology and devices at their own expense.

The NHIA now plans to re-review all items that have been published for more than three years since 2012. However, most “non-reimbursed” items were given that designation because reimbursed items with similar functions were available while the review was being conducted. Based on the administrative principle of legitimate expectations, the Committee suggests the following:

1. Disclose the expected timetable for re-review of the various items on the “non-reimbursed medical device list” due to be re-reviewed.

2. Determine the reimbursement price for re-reviewed items based on their market self-pay prices over the past three years (excluding outliers) so as to reasonably reflect the costs involved and to safeguard the medical rights and interests of all parties. This procedure will ensure that new technology and new devices can continue to be introduced to Taiwan.

3. Request manufacturers to resubmit the recommended price and estimated use information for their items before the re-review process begins, so that this information can be considered in the review. This is vitally important as reimbursement for more than 80% of the items on the list was applied for more than five years ago, and relevant costs have completely changed over that time.

Suggestion 4: Improve access to new medical technologies and medical devices.

The Committee offers the following suggestions for improving access to new medical technology and medical devices that have not been covered by the NHI or are still under review:

1. For new medical technology (including related devices) requiring application to the NHIA for new medical order codes before utilization by hospitals, the NHIA should first issue “virtual” medical order codes to promote the accessibility of new medical technology to solve the current situation in which temporary self-pay codes are only provided to applications that have undergone a Health Technology Assessment.

2. The cost of introducing new medical devices is supposed to be covered within certain procedure fees, but often the amount is not enough to cover the full cost. In such cases, the medical institutions are likely to ask the NHIA to increase the procedure fee, but the review process is lengthy and subject to global budget limitations. In the meantime, those devices are suspended from being used. To facilitate the accessibility of new medical devices, we recommend that before completion of the review, such devices be allowed to apply for continued use under Article 21 of the Medical Care Act.

Suggestion 5: Enhance the transparency of the NHIA review process and implement forward-looking budget planning

5.1 Announce the schedule and minutes of Special Materials Expert Committee meetings prior to PBRS meetings. These minutes have a significant impact on PBRS proceedings but have not been published on the NHIA website prior to a PBRS meeting since 2013.