February 8, 2007
Swissmedic
Swiss Agency for Therapeutic Products
Dr. Hans-Beat Jenny
Acting Director
Hallerstrasse 7
CH-3000 Bern 9
Dear Dr. Jenny:
I have the honor to propose an exchange of letters (EOL)
regarding to the mutual exchange of information on medical
devices, especially on requirements of quality systems and
audits of quality systems. This exchange of information will be
conducted by or through Swissmedic, the Swiss Agency for
Therapeutic Products, Federal Department of Home Affairs
(Swissmedic) in Berne and the Bureau of Pharmaceutical Affairs,
Department of Health (BPA/DOH) in Taipei.
Swissmedic and BPA/DOH recognize that EN ISO 13485 reflects the
requirements of the Medical Devices Directive 90/385/EEC, in
particular its Annex II, and Directive 93/42/EEC, in particular
its Annex II, in as far as the concern of GMP, and the relevant
regulatory requirements of BPA/DOH on GMP. They acknowledge that
the regulatory requirements on medical devices in both markets
reflect the general principles developed by the Global
Harmonization Task Force (GHTF).
BPA/DOH acknowledges that Switzerland has fully implemented EU
regulations for medical devices, and there is a fully
operational Mutual Recognition Agreement (MRA) between the EU
and Switzerland regarding medical devices. Swissmedic
acknowledges that the competent Taiwanese authority has also
established an EOL with the EU having a similar regulatory
framework for quality systems, and that a Technical Cooperation
Program (TCP) is established between Notified Bodies (NB) of the
EU and the Designated Auditing Organizations (DAO) of DOH.
The cooperation between Swissmedic and BPA/DOH in the field of
medical devices could be started immediately by using the
instruments currently available and will include in particular
the following activities and areas:
1.Manufacturers established in Switzerland exporting to the
territory where the Pharmaceutical Affairs Law administrated
by the Bureau of Pharmaceutical Affairs, Department of Health
in Taipei, are applied can under this exchange of letters
allow the EU Notified Bodies with TCP partnership to present
the appropriate audit reports to the competent Taiwanese
authority as part of the documentation regarding access to
this market.
2.Swiss Conformity Assessment Bodies are given the possibility
to participate to the Technical Cooperation Program (TCP)
established between Notified Bodies (NB) of the EU and the
Designated Auditing Organizations (DAO) of DOH.
3.To improve mutual understanding of respective inspection
programs and eventually to eliminate duplication of on site
inspection of manufacturers, Swissmedic and BPA/DOH will draw
the attention of manufacturers on both sides to the advantage
associated to the possibility of working with NB or DAO
participating in the TCP.
4.For manufacturers established in the territory where the
Pharmaceutical Affairs Law administrated by the Bureau of
Pharmaceutical Affairs, Department of Health in Taipei, are
applied exporting to Switzerland whose medical devices legally
bear the CE mark according to the EU legislation, no
additional conformity assessment procedure is required for the
Swiss market. Swissmedic will recognize the accomplishment
derived from TCP cooperation to eliminate duplicate
inspection.
5.An exchange of vigilance information between the two parties
can be best achieved through the participation of Swissmedic
and BPA/DOH at the GHTF-Vigilance exchange program. For
specific problems, both sides can request copies of vigilance
reports from manufacturers on medical device failures/
malfunctions referring to products manufactured in the markets
of both sides.
Swissmedic and BPA/DOH will designate primary contact points to
be responsible under their auspices for overall coordination
under this exchange of letters.
If the activities and the terms set forth in this letter are
acceptable to your Agency, this letter together with your reply
shall constitute an exchange of letters between Swissmedic and
BPA/DOH and shall be implemented upon your reply.
Sincerely,
Chi-Chou Liao, Ph.D.
Director General
Bureau of Pharmaceutical Affairs
Department of Health
4 July 2007
Bureau of Pharmaceutical Affairs
Department of Health
Dr. Chi-Chou Liao
Director General
No.100, Ai Kuo E. Rd.
Taipei 10092
Dear Dr. Liao:
I have the honor to acknowledge receipt of your letter dated 08
February 2007 which reads as follows:
"I have the honor to propose an exchange of letters (EOL)
regarding to the mutual exchange of information on medical
devices, especially on requirements of quality systems and
audits of quality systems. This exchange of information will be
conducted by or through Swissmedic, the Swiss Agency for
Therapeutic Products, Federal Department of Home Affairs
(Swissmedic) in Berne and the Bureau of Pharmaceutical Affairs,
Department of Health (BPA/DOH) in Taipei.
Swissmedic and BPA/DOH recognize that EN ISO 13485 reflects the
requirements of the Medical Devices Directive 90/385/EEC, in
particular its Annex II, and Directive 93/42/EEC, in particular
its Annex II, in as far as the concern of GMP, and the relevant
regulatory requirements of BPA/DOH on GMP. They acknowledge that
the regulatory requirements on medical devices in both markets
reflect the general principles developed by the Global
Harmonization Task Force (GHTF).
BPA/DOH acknowledges that Switzerland has fully implemented EU
regulations for medical devices, and there is a fully
operational Mutual Recognition Agreement (MRA) between the EU
and Switzerland regarding medical devices. Swissmedic
acknowledges that the competent Taiwanese authority has also
established an EOL with the EU having a similar regulatory
framework for quality systems, and that a Technical Cooperation
Program (TCP) is established between Notified Bodies (NB) of the
EU and the Designated Auditing Organizations (DAO) of DOH.
The cooperation between Swissmedic and BPA/DOH in the field of
medical devices could be started immediately by using the
instruments currently available and will include in particular
the following activities and areas:
1.Manufacturers established in Switzerland exporting to the
territory where the Pharmaceutical Affairs Law administrated
by the Bureau of Pharmaceutical Affairs, Department of Health
in Taipei, are applied can under this exchange of letters
allow the EU Notified Bodies with TCP partnership to present
the appropriate audit reports to the competent Taiwanese
authority as part of the documentation regarding access to
this market.
2.Swiss Conformity Assessment Bodies are given the possibility
to participate to the Technical Cooperation Program (TCP)
established between Notified Bodies (NB) of the EU and the
Designated Auditing Organizations (DAO) of DOH.
3.To improve mutual understanding of respective inspection
programs and eventually to eliminate duplication of on site
inspection of manufacturers, Swissmedic and BPA/DOH will draw
the attention of manufacturers on both sides to the advantage
associated to the possibility of working with NB or DAO
participating in the TCP.
4.For manufacturers established in the territory where the
Pharmaceutical Affairs Law administrated by the Bureau of
Pharmaceutical Affairs, Department of Health in Taipei, are
applied exporting to Switzerland whose medical devices legally
bear the CE mark according to the EU legislation, no
additional conformity assessment procedure is required for the
Swiss market. Swissmedic will recognize the accomplishment
derived from TCP cooperation to eliminate duplicate
inspection.
5.An exchange of vigilance information between the two parties
can be best achieved through the participation of Swissmedic
and BPA/DOH at the GHTF-Vigilance exchange program. For
specific problems, both sides can request copies of vigilance
reports from manufacturers on medical device
failures/malfunctions referring to products manufactured in
the markets of both sides.
Swissmedic and BPA/DOH will designate primary contact points to
be responsible under their auspices for overall coordination
under this exchange of letters.
If the activities and the terms set forth in this letter are
acceptable to your Agency, this letter together with your reply
shall constitute an exchange of letters between Swissmedic and
BPA/DOH and shall be implemented upon your reply."
In reply I have the honor to accept, on behalf of Swissmedic,
the foregoing understanding and to confirm that your letter and
this reply shall constitute an exchange of letters between
Swissmedic and BPA/DOH. This exchange of letters has only legal
implications of economic and technical nature. It shall be
effective on today's date.
Sincerely,
Dr. Hans-Beat Jenny
Acting Director