2015 Taiwan Food and Drug Administration

Food and Drug Administration

124

Annex Table 13. Status of the amendments and revisions to relevant

regulations governing medical devices in 2014

Date

Regulation / standard title

Summary

January

Revised the draft of the first point

promulgated in the

Registration

Requirements of Mail-Order Purchases

of Medical Devices by Pharmaceutical

Companies

A total of three Class 2 medical devices, namely body fat analyzers,

condoms, and tampons can now be purchased through mail-order.

Stronger requirements have been imposed upon the pharmaceutical

companies to provide consumer reminders to read product manuals

prior to use and the responsibilities of the companies in providing

regular calibration

January

Promulgated amendments to Articles

4 and 8 as well as Attachment 1 of

Article 3 of

Regulations for Governing

the Management of Medical Device

As of 11 March 2014, medical device manufacturers must

demonstrate compliance to Good Manufacturing Practice (GMP) for

medical devices. Where necessary, amendments have also been

made to achieve the goal of international harmonization

February

Promulgated the revisions to a number

of articles in the

Regulations of

Medicament Manufacturer Inspection

The TFDA signed an Exchange of Letters on the Technical

Cooperation with Liechtenstein which would simplify medical device

GMP applications and shorten the time-to-market for the country's

medical device manufacturers

February

Promulgated the revisions to the

Medical Device Application Form for

Designation Inquiry

Product function and purpose columns have been added, allowing

business firms to voluntarily ascertain the expected function and

purpose of product before submitting medical device designation

inquiry applications and facilitating the determination of product

characteristics

May

Promulgated new technical standards

for

Household Blood Sugar Monitoring

Systems

and nine other

in vitro

diagnostic devices

To strengthen management of

in vitro

diagnostic devices (IVD), TFDA

established technical guidances for nine IVDs, namely

household

blood sugar monitoring systems, pregnancy test agents, IVD

calibration specimens, IVD agents for drug abuse, IVD devices for

glycated hemoglobin, C-reactive protein test reagents, rheumatoid

factor test systems, extrinsic coagulation test instruments

, and

tumor-associated antigen test systems

, providing manufacturers with

a reference when conducting product research and development

and when preparing application and registration documents and

information

August

Released the new version of the

Transfer Document

Amendments were made to the format of the T

ransfer Document

that must be attached when registering transfers of medical device

license permits. The text that originally allowed the original authorizes

to commission the recipient as an agent to register the transfer at

TFDA has been deleted in order to comply with current regulations

September

Promulgated revisions to

Regulation

for Registration of Medical Devices

(1) Clearly stated that pre-clinical testing and the original

manufacturer's quality control documents must include safety

and functional test data, and that the responsible testing lab must

comply with relevant operational practice.

(2) Clearly stated that Class 3 medical devices must comply with the

requirements prescribed in the

Essential Principles and Summary

of Technical Documentation for Medical Device Safety and

Functions

September

Promulgated amendments to

Attachment 1 of Article 3 and

Attachment 2 of Article 4 in the

Regulations for Governing the

Management of Medical Devices

To achieve the goal of international harmonization the amendments of

to Taiwan's medical device regulation items are timely made, among

which is the revision to medical device category, type, and item of a

stair climber

October

Promulgated the

Reference Guide for

Nano-Medical Devices Identification

Provides a reference for businesses researching and developing

nano-medical devices

December

Promulgated

Good Submission

Practice for Medical Device

Registration

Provide support for manufacturers in establishing capabilities for

internal preparations of registration documents for medical devices

and improve the quality of submitted documents, thereby enhances

case approval rate and efficiency