A New Era for the Taiwan Medical Device Regulatory Regime

Both drugs and medical devices have been jointly regulated under the Pharmaceutical Affairs Act (PAA) in Taiwan since the PAA’s enactment in 1970; however, the PAA’s regulatory framework is more relevant to drug products. Given the different nature of drugs and medical devices, the new and diverse development in the medical device industry in recent years, and the need to harmonise the local law with global practices, the regulatory authority, the Taiwan Ministry of Health and Welfare (MOHW), started to evaluate the need to set up a law specifically for the management of medical devices in 2014 and proposed a draft of the Medical Devices Act (MDA) in December 2017. The MDA was passed by the Taiwan congress (the Legislative Yuan) in December 2019 and announced by the President in January 2020. It came into effect in May 2021, as announced by the Taiwan cabinet (the Executive Yuan). After the enactment of the MDA, the provisions relating to medical devices in the PAA ceased to be effective. Together with the enactment of the MDA, the MOHW and its subordinate agency, the Taiwan Food and Drug Administration (TFDA), have promulgated a set of regulations under the MDA to provide further implementation details of the MDA. Most of these regulations also came into effect in or before May 2021. The MDA and its subordinate regulations mark a new start for medical device management in Taiwan. In addition to the key points of the reform in the MDA, observations on its first year of implementation are provided here.

Broadening the scope of industry players

Previously, under the PAA, only domestic companies that were also registered as pharmaceutical firms were permitted to conduct business related to drugs and medical devices, and the definition of the term “pharmaceutical firms” merely included dealers and/or manufacturers of drugs and/or medical devices. 

Medical device firms

After the enactment of the MDA, the term “pharmaceutical firm” in the PAA will only refer to companies engaged in the drug product business, while companies engaged in the medical device sector will be called “medical device firms” under the MDA. This brings greater clarity to the different sets of regulations to be followed by pharmaceutical firms and medical device firms. In addition, non-business-oriented entities such as universities are permitted to be registered as medical device firms under the MDA. In July 2022, the National Cheng Kung University (NCKU) obtained licences as both a dealer in medical devices and a manufacturer of medical devices. It became the first university to obtain both licences.

Dealers in medical devices

Dealers of medical devices, as defined in the PAA, were those engaged in the wholesale, retail, import and export of medical devices. However, in the medical device industry, some companies also engage in renting and/or repairing. These businesses were not covered under the PAA, and this caused ambiguity in legal implementation. Under the newly enacted MDA, medical device dealers also include those engaged in the rental and repair businesses, and their acts are subject to the MDA. 

Manufacturers of medical devices

In addition, the manufacturers of medical devices defined under the PAA were only those engaged in:

• manufacturing and assembling medical devices;
• wholesaling and exporting their own products; and
• importing raw material for their own use.

Nonetheless, in the era of artificial intelligence (AI), many companies are only involved in the design of medical device software and are not involved in the above-mentioned physical manufacturing activities. In addition, some companies only deal with the design of medical devices and subcontract the manufacturing to other companies. Also, owing to the highly developed technological specialisation in the sector, the work involved in manufacturing medical devices has been divided in detail and some companies are only responsible for packaging, labelling, sterilisation, or final inspection and release. While the TFDA has issued some interpretations to include such activities as manufacturing, these interpretations have actually broadened the wording of the PAA. Under the newly enacted MDA, it is clear that medical device manufacturers also include those engaged in the businesses of designing, packaging, labelling, sterilisation, and final inspection and release of medical devices. 

Effects of the broadened scope

By extending the scope of the application of the MDA to the above-mentioned businesses, users of the medical device have more complete protection. This is because those aspects of the sector are now within the coverage of the MDA requirements and businesses need to obtain a licence as a medical device firm from the authority and maintain good distribution practice (GDP) for certain high-risk products. On the other hand, medical device designers are eligible to apply for a medical device firm licence and for marketing authorisation (MA) of a medical device. This will also encourage the designers of medical devices to pursue further development and innovation. An example is that the NCKU plans to obtain an MA for medical device software in late 2022.

Relaxing the regulation on low-risk medical devices

Under the PAA, medical devices were divided into three risk classification levels (ie, Classes I, II, and III), from low risk to high risk. This classification remains in the MDA. Nonetheless, in the PAA, prior to the manufacture and/or import of a medical device, regardless of its classification, an MA issued by the authority (the TFDA) for a medical device should have been obtained by means of an MA application process. Depending on the classification, different documents, such as a free-sale certificate and/or clinical trials data, were required to be submitted. In this respect, under the MDA, certain low-risk Class I medical devices announced by the TDFA could be manufactured and/or imported by simply listing the device online with the TFDA, and the listing can be renewed annually upon application. This relaxation of the regulation of certain low-risk medical devices could accelerate the market launch process for medical device dealers/manufacturers and reduce the TFDA’s workload, so that officials can spend their time and resources on more complicated applications. Six months after the implementation of the MDA, more than 3,000 MAs of Class I medical devices have been transferred to the listing mechanism and the TFDA is able to shift its resources to other fields requiring more attention. 

Fast-track marketing authorisation for novel medical devices

While not specifically provided for in the text of the MDA, it is the clear legislative intent of the MDA, and of certain provisions of the Regulations Governing Issuance of Medical Device MA, Listing and Annual Declaration (MA Regulations; promulgated under the authorisation of the MDA), that a fast-track review process for MA application is available for novel medical devices. In order to encourage the industry to develop novel medical devices that are helpful in protecting citizens’ lives and health and that meet urgent and/or unmet clinical needs, the TFDA will accelerate the review process for such medical devices to allow earlier use. Specifically, for such novel medical devices without significant risk, the medical device firm only needs to submit the most basic safety and efficacy testing results, and the TFDA will grant the MA while simultaneously ordering the MA applicants to conduct post-approval surveillance or a study. While the effective term of an ordinary MA is five years, the term of the MA for such novel medical devices with fast-track approval would be shorter and the length is to be determined by the TFDA based on the results of the above-mentioned post-approval surveillance or study. The extension of the term also depends on these results.

This new mechanism gives those in the industry an incentive to develop novel medical devices, while the authority can still effectively manage the risks through subsequent post-approval surveillance or studies. To further boost the development of novel medical devices, the TFDA established the AI Medical Device Task Force Office (AI office) in June 2022 to provide case-by-case guidance to applicants to overcome the regulatory and technological obstacles.

Inclusion of management requirements for clinical trials

While the PAA required that medical devices be supplied for use in clinical trials only after obtaining TDFA approval, the requirements for clinical trials of medical devices were not addressed in the PAA. They are provided in the Medical Device Good Clinical Practice Guidance (GCP guidance), which was promulgated by the TFDA without authorisation from the PAA. It is now clearly stipulated in the MDA that:

• a medical device clinical trial can be conducted only after the study protocol has been approved by the TFDA and after the study subjects’ consent has been obtained;
• the institution should exercise the necessary duty of medical care;
• the institution should notify the TFDA of any adverse events occurring during or after the clinical trials; and 
• the TFDA may suspend or terminate a clinical trial or order the institution to take other necessary measures if the TFDA considers there might be a safety risk in the medical device study.

Nonetheless, other details of the requirements in the GCP guidance have been included in the newly promulgated Regulations on Good Clinical Practice for Medical Devices (GCP regulations) under the authorisation of the MDA, and the requirements in the GCP Regulations are generally aligned with international practice. It is also provided in the MDA that for medical devices without significant risks (identified by the TFDA), clinical trials can be conducted without prior approval from the TFDA.

Relaxing the sales channels

Under the PAA, medical devices could only be physically sold by pharmacies or be supplied to patients by healthcare institutions. Only a limited range of medical devices listed by the TFDA could be sold online. Considering the thriving technology sector, the MDA allows the TFDA to relax the channel of sale for certain medical devices. For example, certain Class I devices can be sold via vending machines. 

Traceability during the product life cycle

It is stipulated in the MDA that medical device firms and healthcare institutions should establish and maintain records on the direct supply source and flow of the high-risk medical devices (as decided by the TFDA). The traceability records of certain medical devices (as assessed by the TFDA) will need to be submitted to the TFDA. The TFDA has been promoting such management through its Unique Device Identification (UDI) system since 2015. Under the MDA, the UDI will become mandatory, with different transition periods for certain Class II and III medical devices. For example, the UDI becomes mandatory from:

• 1 June 2021 for Class III implantable devices;
• 1 June 2022 for Class III non-implantable devices; and
• 1 June 2023 for Class II devices.

For those medical devices subject to the UDI system, the traceability records should include the UDI. The traceability records should be preserved for three years, but for those that are required to be submitted to the TFDA as mentioned previously in this section, the records should be preserved permanently.

Quality management systems and distribution management

The MDA also states that dealers of certain medical devices (as identified by the TFDA) and/or manufacturers of medical devices (except for those exempted by the TFDA) should establish quality management systems (QMS) and/or GDP regarding storage, transportation, distribution services, and staffing. Specifically, the detailed requirements are set out in the Medical Device Quality Management System Regulations (QMS regulations) and the Medical Device Good Distribution Practices Regulations (GDP Regulations). The standards in both regulations are prescribed with reference to the ISO 13485, the medical industry's optimal medical device standard, to harmonise with global practice. A medical device manufacturer (except for those exempted by the TFDA) cannot commence the manufacture of a medical device without being issued QMS certification by the TFDA. For overseas manufacturers importing medical devices, the provisions regarding QMS requirements, also known as the Quality System Documentation system (QSD), should apply mutatis mutandis. For overseas manufacturers, the TFDA may conduct an on-site inspection if necessary to determine whether they meet the QSD requirements. Nonetheless, due to the COVID-19 pandemic, the TFDA has ceased such overseas inspections. Similarly, the dealers of the medical devices within this scope cannot commence the wholesale, import or export of medical devices before obtaining GDP certification from the TFDA.

Post-marketing surveillance

Safety monitoring

While there is a provision in the PAA stipulating that the TFDA may prescribe a period of time for safety surveillance for each approved medical device, the MDA takes a further step by additionally requiring that, for certain high-risk medical devices identified by the TFDA, the medical device firms holding the MA should monitor the product safety according to a safety monitoring plan approved by the TFDA for a period of time set by the TFDA. The healthcare institutions should also assist in providing relevant safety monitoring data to the medical device firms. Such medical device firms should periodically submit safety monitoring reports to the TFDA. Failure to comply with such safety monitoring requirements would result in the prolonging of the monitoring period and/or the cessation of manufacture, import and/or sales of the medical devices at issue. Serious situations might result in the revocation of the MA or the online listing of that medical device.

Reporting of serious adverse events and other findings

It is briefly stated in the PAA that healthcare institutions, pharmacies, and pharmaceutical/medical device firms should report any serious adverse reactions caused by drugs or medical devices; however, the reporting of serious adverse events (SAE) is not addressed in the PAA. In this respect, the MDA more clearly requires that medical device firms and healthcare institutions should report any SAE to the TFDA upon becoming aware of them. 

The MDA more broadly requires that, upon finding that a medical device is likely to cause harm to human health, the MA/online listing holder of the medical device should immediately and proactively report this to the TFDA and take corrective, preventive measures. Such measures might include the preparation of alerts, replacement of parts and accessories, product testing, suspension of use, product recall or other necessary measures. These measures should be disclosed in a reasonable manner to healthcare institutions, other medical device firms and the users.

Post-marketing safety management by the TFDA

In addition to the above-mentioned reporting by medical device firms, if the TFDA considers that there is concern about the safety or therapeutic effect of medical devices after re-evaluation, it may order the medical device firms to make corrections within a prescribed period. When necessary, it may further order them to withdraw, recall or suspend the manufacture, import, or sale of the medical devices. For those who fail to make corrections within the period or if there is a serious safety concern, the MA or online listing of the relevant medical device may be revoked.

All these post-marketing surveillance mechanisms should drive the medical device firms to maintain the safety and quality of their products, which will better protect the safety of the users.

Relaxing the regulations around medical device recall

Under the PAA, a recall was required for any change in the packaging, instructions for use and/or labelling of the medical device unless the products with pre-amended packaging, instructions for use, and/or labelling have been affixed with an examination stamp by the local authority. After the implementation of the MDA, such changes will no longer trigger a recall of the products as long as the MA is still valid. This relaxation can prevent medical device firms from having to recall products that have no actual quality or compliance issues.

Reporting mechanism for necessary medical devices

Medical device firms that hold licences for necessary medical devices, as identified by the central competent authority, shall, where they are incapable of continuing to manufacture/import or likely to have insufficient supply of said medical devices, report to the central competent authority at least six months in advance. They also must, if they are unable to report within the aforementioned period due to a natural disaster or other incidents not attributable to the medical device firms, report this to the central competent authority within 30 days after the occurrence of such incidents.

The central competent authority may, upon receiving the report described in the preceding paragraph or upon becoming aware of the likelihood of insufficient supply of necessary medical devices, register it on a public website.

Conclusion

Other than the new features described, the rest of the MDA generally maintains the existing regulatory requirements for medical devices under the PAA. For example, the advertisement of medical devices requires prior approval by the local authority. Also, some requirements that had been implemented through the TFDA’s previous interpretations, rulings and/or guidance have been incorporated into the text of the MDA and provide more clarity.

After one year of the implementation of the MDA, the management of medical devices has become more flexible and, at the same time, stricter and clearer. With the recent establishment of the AI office, the TFDA has shown its ambition to provide more incentives for innovative companies to efficiently and effectively join the industry and develop more products beneficial to patients, the healthcare industry and society more broadly.