Taiwan Update – 2021
Welcome to the uh rahzy Group Medical Device Regulatory Update! Today’s update is from Taiwan, and will cover the following topics:
The medical device act that has been enforced since May 1st this year, the implementation of the Unique Device Identifier system for Class III implantable medical devices in June 2021; the introduction of a new registration pathway for low-risk devices; the change in the registration fee that has been implemented since May 2021, and lastly, the update on abridged registration pathway for class II medical devices. Let’s review each update in detail.
The Medical Devices Act was issued in 2020 but has just been enforced in May 2021, and here are some of the highlights: The definition of medical device manufacturer has been broadened to include entities that conduct activities, such as packaging, labeling, sterilization, final inspection and release, or design and marketing. Therefore, moving forward, a QSD approval might also be required for those sites, including the original equipment manufacturer or OEM; The medical device dealers for certain high-risk products are now required not only to include a repair and maintenance service, but also to have a Good Distribution Practice certification; To establish a proper traceability record, the UDI for moderate to high-risk products must be submitted to the authority before being placed in the market. To provide better access to a market, a new registration pathway called “product listing” will be implemented for certain low-risk devices. As part of the efforts to increase the post marketing surveillance in Taiwan, certain high-risk medical device dealers will be required to submit a periodic safety monitoring report.
Prior to placing products on the market, the medical device license holder will be required to upload the corresponding product information to the UDI information management platform, which is the UDI database that is established by the Taiwan FDA. This process will require identification information such as license number and model number. It will also require device information such as catalogue number, product description and batch number, as well as other technical characteristics.
However, The implementation of this process will be done in phases. Starting with Class III implantable devices in June 2021, followed by Class III non-implantable devices in June 2022, and then Class II devices in June 2023. The Taiwan UDI must be created according to the standards formulated by the International Medical Device Regulators Forum (IMDFR).
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Under the new medical device act, some of the class I medical devices are subject to product listing. There are 68 certain low-risk products that are eligible for this pathway. The application submission for this pathway will be done online like any other program or pathway. Under this pathway, the license holder is also required to submit an annual retention to the central competent authority. For those who fail to file such a declaration, the original listing shall become invalid. However, the details about the criteria and procedure for this pathway have not been provided by the Taiwan FDA.
In April 2021, the Taiwan FDA updated the registration fee for some services that they provided. As you can see in the table, the new fees are 1.5 to two times higher than the old fees, except for the renewal fee for class II and III. Fees for new services are also introduced, such as fee for class one product listing and the fee to issue a license or registration certificate.
Previously, the abridged registration pathway allowed Class II devices with both EU and US market clearance, an exemption from submission of the pre-clinical data. However, under the updated pathway, products must meet one of the following requirements to be eligible for the abridged registration pathway: First, the product must conform to the standards that have been pre-determined by the authority. Currently, only 8 low-risk devices belong to this category. While for the second requirement, 34 low or moderate-risk devices on this list will be eligible for an abridged registration pathway, regardless of its overseas approval status. Unfortunately, the change in this pathway will close the door for many imported Class II devices that are currently eligible under the previous abridged pathway requirement.
That's it for our update today! If you have any comments or questions, please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.