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法規名稱: MEMORANDUM OF COOPERATION BETWEEN THE TAIWAN-JAPAN RELATIONS ASSOCIATION AND THE JAPAN-TAIWAN EXCHANGE ASSOCIATION ON THE FIELD OF MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM REQUIREMENTS
簽訂日期: 民國 107 年 11 月 30 日
生效日期: 民國 107 年 11 月 30 日
簽約國: 亞太地區 > 日本
沿革:
1.Signed on November 30, 2018 Entered into force on November 30, 2018

 
THE TAIWAN-JAPAN RELATIONS ASSOCIATION and THE JAPAN-TAIWAN
EXCHANGE ASSOCIATION (hereinafter individually referred to as
the “ Side ” or collectively as the “ Sides ” ), having
regard to paragraph 3 (7) of the Arrangement between the
Association of East Asian Relations (now the Taiwan-Japan
Relations Association) and the Interchange Association (now the
Japan-Taiwan Exchange Association)for the Establishment of the
Respective Overseas Offices on 26 December 1972, and under the
Arrangement between the Association of East Asian Relations (now
the Taiwan-Japan Relations Association) and the Interchange
Association (now the Japan-Taiwan Exchange Association) for the
Establishment of the Framework of the Cooperation on the Medical
Products Regulation on 5 November 2013, will cooperate with each
other in order to obtain necessary consent from the relevant
authorities of both Sides with regard to the matters as
described below.

1. Both Sides will cooperate for medical device Quality
Management System (QMS) audit reports and the QMS compliance
certifications to be utilized to reduce the burden of both
Japanese and Taiwanese manufacturers in demonstrating
compliance of medical devices, including In Vitro Diagnostics
(IVDs), with the QMS regulations by relevant authorities of
each Side.

For this purpose, the Japan-Taiwan Exchange Association will
request the relevant authorities of Japan, namely the
Ministry of Health, Labour and Welfare (MHLW) and
Pharmaceuticals and Medical Devices Agency (PMDA), to:

accept medical device QMS audit reports and the QMS
compliance certifications, which are prepared by the Taiwan
Food and Drug Administration, Ministry of Health and Welfare
(TFDA) in Chinese and translated by manufacturers into
English or Japanese; and

regard the medical device QMS audit reports and the QMS
compliance certifications as part of the information to
demonstrate the manufacturer ’ s compliance with Japan
Ordinance on Standards for Manufacturing Control and Quality
Control of Medical Devices and In Vitro Diagnostics (MHLW
Ministerial Ordinance No. 169); and

put Taiwanese manufacturers into the same risk level with
that of United States and European Union, and make the most
of the QMS audit reports and the QMS compliance
certifications to reduce on-site inspection according to the
notification (PFSB/CND (Yakushoku-kanma) Notification No.
1024-10October 24, 2014) attachment 1, 2(1)c)[For “ mutual
usages of Inspection results of other Inspection bodies, etc.
”, they will be as follows: For foreign manufacturing sites
in partner countries etc. with which Japan has exchanged an
MOU etc., when a copy of a certificate of suitability or a
QMS Inspection result report issued by the partner country
etc. based on prescriptions of the MOU etc. has been
submitted, or other certain requirements have been
satisfied].

For the same purpose, the Taiwan-Japan Relations Association
will request the relevant authorities of Taiwan, namely TFDA,
to:

accept medical device QMS audit reports and the QMS
compliance certifications, which are prepared by PMDA or MHLW
’ s Registered Certification Bodies (RCBs) in Japanese and
translated by manufacturers into English or Chinese; and

regard the medical device QMS audit reports and the QMS
compliance certifications as part of the information to
demonstrate the manufacturer ’ s compliance with Taiwan
medical device GMP regulation (Chapter 2, Part 3 Good
Manufacturing Practices for Medical Devices of Pharmaceutical
Good Manufacturing Practice Regulations); and

require none of the quality system procedural documentation
except quality manual of Japanese manufacturers for medical
device QMS document inspection, except for some procedures of
quality system when necessary; and announce the list of RCBs
and approve any new RCB seeking to participate in the
exchange of medical device QMS audit reports and the QMS
compliance certifications nominated by MHLW except for when
necessary.

2. Both Sides will cooperate for prior notification of relevant
authorities ’ visit schedule to medical device manufacturers
in Taiwan/Japan in order to facilitate mutual understanding
of respective quality management system regulations.

3. Both Sides will cooperate to hold training workshops on the
occasion of annual meetings to enhance the understanding of
medical device QMS requirements in Taiwan and Japan and
request the relevant authorities for their support.

4. This Memorandum will enter into force on the date of
signature.

5. This Memorandum may be modified by mutual written consent of
the Sides.

6. This Memorandum may be terminated by either Side by giving
the other Side a 90-day prior written notice.


In witness whereof, the representative of the Taiwan-Japan
Relations Association and the representative of the Japan-Taiwan
Exchange Association signed this Memorandum.

Signed in Taipei on 30 November 2018 in duplicate in English.


FOR THE FOR THE
TAIWAN-JAPAN JAPAN-TAIWAN
RELATIONS EXCHANGE
ASSOCIATION: ASSOCIATION
__________________ __________________
CHIOU I-Jen OHASHI Mitsuo
Chairman Chairman
資料來源:全國法規資料庫