January 9, 1998
Mr. Stephen S. F. Chen
Representative
Taipei Economic and Cultural
Representative Office in the U.S.
4201 Wisconsin Avenue, N.W.
Washington, DC 20016-2137
Dear Representative Chen:
I have the honor to propose an exchange of letters regarding the
mutual exchange of information on medical devices, including Qu-
ality Systems requirements inspectional information. This excha-
nge of letters will further the cooperation between public heal-
th professionals from the United States of America and Taiwan.
The Taiwan Relations Act (Public Law 96-8, April 19, 1979) auth-
orizes the continuation of commercial, cultural and other relat-
ions between the people of the United States and the people of
Taiwan. Such relations are conducted by or through the American
Institute in Taiwan (AIT), a non-profit corporation, incorporat-
ed under the laws of the District of Columbia. The Taipei Econo-
mic and Cultural Representative Office (TECRO), formerly the Co-
ordination Council for North American Affairs (CCNAA), is the i-
nstrumentality which has been established to provide assurances
and take actions on behalf of the people on Taiwan. For the pur-
poses of this exchange of letters, AIT will work in association
with the U.S. Food and Drug Administration (FDA) in Rockville,
Maryland, in administering this program. TECRO will perform a s-
imilar function in affiliation with the Department of Health (D-
OH) in Taipei.
Upon request from TECRO, AIT intends to furnish purged copies (i
.e., the non-public information will be removed) of medical dev-
ice Establishment Inspection Reports (EIR's) of the United Stat-
es manufacturers that export to Taiwan.
Further, it is the intention of AIT to notify TECRO prior to sc-
heduling an inspection in Taiwan. Additionally, AIT intends to
be receptive to requests by TECRO to observe FDA inspections of
medical device manufacturers in Taiwan. TECRO may also make arr-
angements for AIT to observe DOH inspections of medical device
manufacturers in Taiwan. It is intended that the mutual observa-
tion of each other's inspections will provide opportunities for
the comparison of inspection and reporting techniques and to fa-
cilitate a mutual understanding of respective quality assurance
programs. AIT also intends to provide, upon request, purged Dev-
ice Experience Network reports (in the United States this is ca-
lled the ”Medwatch Program”). The Medwatch Program is a vigil-
ance system designed to provide reports from manufacturers on d-
evice failures/malfunctions required by the medical device repo-
rting regulations. When AIT becomes aware of particular circums-
tances in which a medical device presents an imminent and serio-
us danger to the public, AIT intends to communicate the findings
to TECRO in accordance with Title 21, Code of Federal Regulatio-
ns, Part 20.
AIT and TECRO will seek to coordinate and implement the activit-
ies of this exchange of letters with their designated represent-
atives, the FDA and the DOH. Each side shall designate a program
coordinator to be responsible under its auspices for overall co-
ordination of the activities under this exchange of letters. AIT
and TECRO program coordinators will meet at times and places of
their choosing to review the operation of the information excha-
nge.
If the activities and the terms set forth in this letter are ac-
ceptable to TECRO, this letter together with your reply shall c-
onstitute an exchange of letters between AIT and TECRO and shall
be implemented upon your reply.
Sincerely,
[Signed]
Richard C. Bush
Chairman of the Board
and Managing Director
January 9, 1998
Dr. Richard C. Bush
Chairman of the Board
and Managing Director
American Institute in Taiwan
1700 North Moore Street, 17th Floor
Arlington, VA 22209
Dear Dr. Bush:
I have the honor to acknowledge receipt of your letter dated Ja-
nuary 9, 1998 which reads as follows:
”I have the honor to propose an exchange of letters regarding
the mutual exchange of information on medical devices, including
Quality Systems requirements inspectional information. This exc-
hange of letters will further the cooperation between public he-
alth professionals from the United States of America and Taiwan.
The Taiwan Relations Act (Public Law 96-8, April 19, 1979) auth-
orizes the continuation of commercial, cultural and other relat-
ions between the people of the United States and the people of
Taiwan. Such relations are conducted by or through the American
Institute in Taiwan (AIT), a non-profit corporation, incorporat-
ed under the laws of the District of Columbia. The Taipei Econo-
mic and Cultural Representative Office (TECRO), formerly the Co-
ordination Council for North American Affairs (CCNAA), is the i-
nstr mentality which has been established to provide assurances
and take actions on behalf of the people on Taiwan. For the pur-
poses of this exchange of letters, AIT will work in association
with the U.S. Food and Drug Administration (FDA) in Rockville,
Maryland, in administering this program. TECRO will perform a s-
imilar function in affiliation with the Department of Health (D-
OH) in Taipei.
Upon request from TECRO, AIT intends to furnish purged copies (i
.e., the non-public information will be removed) of medical dev-
ice Establishment Inspection Reports (EIR's) of the United Stat-
es manufacturers that export to Taiwan.
Further, it is the intention of AIT to notify TECRO prior to sc-
heduling an inspection in Taiwan. Additionally, AIT intends to
be receptive to requests by TECRO to observe FDA inspections of
medical device manufacturers in Taiwan. TECRO may also make arr-
angements for AIT to observe DOH inspections of medical device
manufacturers in Taiwan. It is intended that the mutual observa-
tion of each other's inspections will provide opportunities for
the comparison of inspection and reporting techniques and to fac
ilitate a mutual understanding of respective quality assurance
programs. AIT also intends to provide, upon request, purged Dev-
ice Experience Network reports (in the United States this is ca-
lled the ”Medwatch Program”). The Medwatch Program is a vigil-
ance system designed to provide reports from manufacturers on d-
evice failures/malfunctions required by the medical device repo-
rting regulations. When AIT becomes aware of particular circum-
stances in which a medical device presents an imminent and seri-
ous danger to the public, AIT intends to communicate the findin-
gs to TECRO in accordance with Title 21, Code of Federal Regula-
tions, Part 20.
AIT and TECRO will seek to coordinate and implement the activit-
ies of this exchange of letters with their designated represent-
atives, the FDA and the DOH. Each side shall designate a program
coordinator to be responsible under its auspices for overall co-
ordination of the activities under this exchange of letters. AIT
and TECRO program coordinators will meet at times and places of
their choosing to review the operation of the information excha-
nge.
If the activities and the terms set forth in this letter are ac-
ceptable to TECRO, this letter together with your reply shall c-
onstitute an exchange of letters between AIT and TECRO and shall
be implemented upon your reply.”
In reply I have the honor to accept, on behalf of TECRO, the fo-
regoing understanding and to confirm that the aforesaid letter
and this reply shall constitute an exchange of letters between
AIT and TECRO, effective on today's date.
Sincerely,
[Signed]
Stephen S. F. Chen
Representative