Medical devices exempted from QMS certification requirements
Taiwan Food and Drug Administration (TFDA) released the final list of medical devices exempted from QMS certification under the Medical Device Act. The exemption list is effective starting from 16 July 2021.
Updated IVD Inspection Guidelines
TFDA publishes an updated version of the Guidelines for In Vitro Diagnostic Medical Device Inspection and Registration, which presents guidance on submission procedures and requirements for IVDs under the Medical Device Act. There are no significant differences between this version and the prior advice document. Guidelines for Home-Use In Vitro Diagnostic Medical Devices Inspection and Registration, which was attached to the same release, contained unique guidelines for home-use IVD goods.
Updated Cybersecurity Standards for Manufacturers
The TFDA updated its Medical Device Cybersecurity Guidelines, adding additional sections on information security design principles and pre-market approval procedures. Manufacturers of medical devices that integrate software, as well as software as a medical device (SaMD), including mobile applications, must follow the requirements.
TCP III in Progress
On 25 May 2021, TFDA has announced that the Taiwan–EU Technical Cooperation Program version II (TCP II) for the exchange of QMS reports has come to an end, and TCP III will begin. Certificates from approved TCP-participating EU Notified Bodies may still be utilised for an abbreviated QMS application throughout the transition period, which runs from 26 May to 31 December 2021.
Guidance to recognize predicate devices
TFDA has issued a statement outlining the criteria and procedure for determining a substantially identical predicate device in Taiwan. In addition, the notice includes guidelines for writing a letter of inquiry to the TFDA in such cases.
Submission of Regulatory Documents during Pandemic Covid-19
TFDA has announced that due to the COVID-19 pandemic's restrictions on in-person meetings, submissions for medical device registration, modification, and renewals must now be submitted online in CD-ROM format. This condition will be abolished after Taiwan's pandemic alert level III is lifted.
Covid-19 test may be supplied via EUA
In regards to the pandemic, TFDA announced that Covid -19 test kits can be manufactured & imported to Taiwan via Emergency Use Authorization (EUA). The announcement describes the specific requirements for each type of application. EUA regulations can be accessed here.
Updated Guidance on Pre-Clinical Testing
TFDA has issued an updated guidance document on pre-clinical testing for medical devices that describes the affected medical devices as well as data requirements.
New guidance on AI/ML CADe software
TFDA also published a guidance document on artificial intelligence/machine learning computer-aided detection (AI/ML CADe) software that provides guidelines to manufacture these devices. The guidelines involved are on product technical documentation, safety & verification as well as clinical evidence requirements
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