Page 84 - 2020Taiwan Food and Drug Administration Annual Report

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standards and techniques are discussed through meetings and activities such as the expert
meetings, inspectors training, and the review and inspection team meeting, to reach a consensus
on the inspection standards.
To establish a management mechanism for testing quality, TFDA plans to conduct written
inspection and on-site inspections through an inspection team, to verify whether or not the
laboratory complies with relevant standards of quality management through the review and
inspection team and then it can be registered for management. In addition, the registered

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extension of registration every 3 years, so that the laboratories can be continuously monitored
for the quality of testing. At the same time, TFDA fully disseminated the related regulations and
operating procedures for registration through counseling, consultation, laboratory workshop and
seminar.

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I. Stipulated the regulations for registration operations of precision medicine
molecular testing laboratory
According to the “Guidance on Laboratory Developed Tests and Services (LDTS) for
precision medicine molecular testing,” TFDA established the operating regulations in 2019,

including the key points for registration management of precision medicine molecular testing
laboratory, application instructions, application review, and aperiodic review operation
principles; moreover, TFDA conducted 2 expert meetings, 1 inspector training, and 2 review and
inspection team meetings, so that the registration review and management mechanism can be
more comprehensive with the discussion and opinions in the meeting.

II. Conducted counseling and introduction workshop
As of the end of 2019, TFDA has conducted counseling for 3 laboratories as well as
3 laboratory introduction sessions and 1 seminar, so that the laboratories can have a better
understanding of the relevant regulations for registration.

III. Registration operations
We started to accept applications for registration of precision medicine molecular testing
laboratories in 2019. Three laboratories have applied for registration. TFDA will continue to

conduct the registration operations and to enhance the testing quality of precision medicine
molecular testing laboratories.

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