Page 119 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name
announcement
Advance notice of the draft of the
November “Regulations Governing Contract
15 Manufacturing of Medical Devices”
November Advance notice of the draft of “the
19 Regulations Governing Border
Inspection and Examination of
Imported Medical Devices”
Advance notice of the draft: “Except
for Daily Wearable Daily Disposable
Contact Lenses, Advertisements
of Other Contact Lenses Shall
Be Published Only in the Medical
Publications, Mass Media, or Related
November Medical Academic Activities That
25 Are for the Exclusive Participation of
Medical Personnel”
Advance notice of the draft of the
“Regulations Governing Issuance of
Medical Device License, Listing and
Annual Declaration”
November Announced: “Examples of Proper and The document can be used as a reference
30 Improper Advertisement Wording of for writing and revision of advertisements for
Class I Medical Devices” (for 10 items) Class I medical devices.
December Established the “Standards for the 6SHFL¿HG WKH SUHPLVHV ZRUN DUHDV IDFLOLWLHV
10
Establishment of Medical Device equipment and hygiene conditions of medical
Manufacturers”
December Amended the “Guidance for Medical
24 6RIWZDUH &ODVVL¿FDWLRQ´
December Advance notice of the draft of the
30 “Enforcement Rules of Medical
Devices Act”
December Advance notice of the draft of the
31 “Regulations Governing Commission
of Medical Devices Management
and Accreditation of Commissioned
Institution”
Important content
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responsibilities, contract requirements,
labeling, packaging and other related matters
for contract manufacturing of medical devices.
Established the regulations specifying
imported medical device items that require
random inspection and tests, and that can only
be released after meeting all the requirements,
as well as the test items, methods, procedures,
scope, charges and other relevant matters.
This draft is formulated in accordance with
the authorization of Article 44 of the Medical
Devices Act. The central competent authority
may limit advertisement channels of specific
medical devices.
Established the regulations governing the
registration and market approval of medical
devices, the change, transfer, registration
extension, replacement for a damaged license,
replacement for a lost license, or the rules for
the listing and annual declaration of medical
devices.
device manufacturers.
Specified Taiwan’s management of health
promotion products, and provided a reference
for companies from other industries entering
the medical industry to develop health
promotion products.
Relevant details and technical specifications
have been established in the enforcement
rules in accordance with the provisions of the
Medical Devices Act (parent law).
Specified the regulations for the commission
and accreditation of medical device
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of interests and other matters to be followed.
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