Medical devices had long been regulated under the Pharmaceutical Affairs Act (PAA) as an incidental part of drugs. With the rapid growth of domestic medical device industry, this practice was increasingly criticized as being out of date. The call for change got extra momentum as the risk-based classification system employed in the PAA for regulating medical devices had gradually lost flexibility in actual implementation over time. It was in this context that a bill to create a sui generis regime was introduced into Taiwan’s congress in 2018. The new law, named Medical Device Management Act, was passed on December 13, 2019, and was promulgated by the President on January 15, 2020. As for the implementation date, it will be determined by the government soon.
What follows is a brief introduction of some of the significant features of the new law.
1. Inclusion of Designers and Repairers
Manufacturers and sellers of medical devices are still the main duty-bearers, but their definition has been expanded. Under the new law, a designer is deemed to be a manufacturer of a medical device it designs, so long as the medical device is circulated in the market with the designer’s name being disclosed. Similarly, a person that engages in leasing or maintenance of a medical device is deemed to be a seller, as has been the case with an importer or exporter of a medical device. Articles 9-11.
2. Deregulation on Low-Risk Devices
The three-level classification system continues to exist in the new law, but with more flexibility, especially in terms of Level I devices which are deemed to pose the lowest risk. Under the new law, Taiwan’s Ministry of Health and Welfare (MHW) will designate certain Level I devices as being exempt from premarket review. These devices can be lawfully manufactured and sold after having been registered in an information communication system to be set up by the MHW, and the registration is renewable annually upon application. Further, some Level I devices, also to be specified by the MHW, will be allowed to be sold via vendor machines (in the cases of condoms or hygiene masks, for instance) or electronic channels. Articles 13, 18, & 25.
3. Fast-Track & Short-Term Certificate for Novel Devices
Where a novel medical device is concerned, the MHW has the discretion to grant a certificate of premarket approval with a shorter-than-standard term (the standard term being five years) as a condition for a fast-track premarket review. As the legislative notes explained, where a medical device is novel and “fulfills unmet clinical needs,” the premarket review proceeding should be so simplified as to require the submission of “the most basic safety and efficacy testing results” only. As a quid pro quo for a speedy approval, the MHW can require the applicant conduct a post-approval safety surveillance/study on the medical device, and concurrently shorten the term of the certificate based on the expected time needed to complete the post-approval reports, which shall be submitted before the term expires if a new term is desired. Article 27.
4. Quality Management System & Good Distribution System
Manufacturers and sellers are required to establish quality management systems and good distribution systems, respectively, for their medical device products. Manufacturing and selling cannot commence without a certificate issued by the MHW based on the results of an inspection. The same rules apply to an importer, while the MHW is empowered to “travel abroad to inspect the foreign manufacturing premises on a regular basis or when the need arises.” Articles 22 & 24.
5. Track & Trace
Medical device manufacturers and sellers along with medical institutions shall establish and preserve records on the direct supply source and flow of the medical devices under their control, and shall keep complete records on the tracking and tracing of these medical devices for an interim period of at least five years, unless the devices are sold directly to consumers. Article 19.
6. Smarter Regulation on Clinical Trials
A medical institution or any other entity permitted to conduct a clinical trial for a medical device is subject to the duty to notify the MHW of any relevant adverse events occurring during the clinic trials. The MHW can suspend or terminate a clinical trial upon discovering a security risk in it. Meanwhile, a clinical trial can be conducted directly without the need to obtain a permission in advance if the tested medical device has been recognized by the MHW as posing no significant risk. Articles 37-39.
7. Post-Approval Safety Surveillance
MHW has the discretion to designate certain medical devices (which can fall within any class) for which the manufacturer/seller holding a relevant certificate of premarket approval or registration shall perform a post-approval or post-registration safety surveillance. The MHW can further provide how long the surveillance should continue and how it should be performed. Non-compliance in the most serious scenario may result in revocation of the certificate of approval or registration. As for medical institutions employing such medical devices, they are obligated to provide relevant safety surveillance data to the device manufacturer/seller.
On the other hand, whether with or without a duty to conduct a post-approval or post-registration safety surveillance, medical device manufacturers/sellers shall notify the MHW of any substantial adverse event or human health risk from medical devices under their control. When a human health risk is identified, manufacturers/sellers shall take immediate corrective and/or preventive measures. Articles 47-49.