Jul 24, 2021

Final list of medical devices exempt from QMS certification requirements now available

In a significant development, the Taiwan Food and Drug Administration (TFDA) has published the final list of devices (links in Chinese) exempt from Quality System Documentation (QSD) certification under the Medical Devices Act. This includes 125 Class I non-sterile devices, an increase from the 90 devices listed in the previous draft document as not needing to meet the agency’s quality management system (QMS) certification requirements. As we noted previously, the low number of devices on the draft list led to concerns that many hitherto exempt devices would require registration under the new regulation. The exemption list is effective as of July 16, 2021.

Below are other new regulatory developments that have taken place since our most recent Taiwan news roundup in early May.

TFDA publishes updated IVD inspection guidances

The TFDA provided a revised version of the Guidelines for In Vitro Diagnostic Medical Device Inspection and Registration, which provides guidance on the submission procedures and requirements for IVDs under the Medical Devices Act. There are no major changes in this version compared to the previous guidance document. The agency provided special instructions pertaining to home-use IVD products in Guidelines for Home-Use In Vitro Diagnostic Medical Devices Inspection and Registration, attached to the same announcement.

Updated cybersecurity guidelines for manufacturers

The TFDA updated the Guidelines on Medical Device Cybersecurity, providing new sections on information security design principles and pre-market review requirements. The guidelines apply to manufacturers who develop and/or produce medical devices that include software, as well as software as a medical device (SaMD), including mobile applications.

TCP III is now in progress

The TFDA also announced the end of the Taiwan–EU Technical Cooperation Program version II (TCP II) for the exchange of QMS reports on May 25, 2021 and the beginning of TCP III. The new version is in progress from May 26 to December 31, 2021, during which time certificates from designated TCP-participating EU Notified Bodies (a list is attached to the announcement) may still be used for an abbreviated QMS application.

Guidance on identifying predicate devices

The TFDA recently published an announcement detailing the criteria and procedure for identifying a substantially equivalent predicate device in Taiwan. The announcement also provides instructions for submitting a letter of inquiry to the TFDA regarding such matters.

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Regulatory submissions in CD-ROM format

Another announcement states that, due to restrictions on in-person meetings relating to the COVID-19 pandemic, submissions for medical device registration, modification, and renewals should now be submitted electronically in CD-ROM format. The announcement specifies that this requirement will end when the epidemic alert level III is lifted in Taiwan.

COVID-19 test kits may be marketed through EUA

On the subject of the pandemic, the TFDA announced that COVID-19 test kits, including antigen, antibody (quantitative and semi-quantitative), and nucleic acid-based tests, may be manufactured and imported into Taiwan through an Emergency Use Authorization (EUA). Specific requirements for each type of application are outlined in the annexes to the announcement, and the regulation on EUA is available to read here.

Updated guidance documents on pre-clinical testing of medical devices

The TFDA also published updated guidance documents on pre-clinical testing of the following devices: absorbable and non-absorbable sutures, orthopedic internal and external fixation devices, and spinal intervertebral body fixation orthosis and intervertebral body fusion devices. These guidelines specify the relevant pre-clinical data requirements, along with the corresponding test methods and standards to verify compliance of the device.

New guidance on AI/ML CADe software

Finally, a new TFDA guidance document deals with artificial intelligence/machine learning computer-aided detection (AI/ML CADe) software. The document provides directions to manufacturers of these devices regarding product technical characteristics, safety and function verification information, and clinical evidence requirements. The guidance notes that, with the AI/ML field advancing rapidly, it is likely to undergo updates in the future.

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Author

  • Timothy Herr

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