This Memorandum of Understanding is entered into by the Taiwan
Food and Drug Administration (hereinafter referred to as "TFDA")
and the Federal Office for Safety in Health Care / Austrian
Agency for Health and Food Safety (hereinafter referred to as "
BASG/AGES") (hereinafter referred to as “ the Parties ” ), for
the purposes of furthering cooperation and collaboration between
the Parties and fostering information exchange concerning safety
of medical. In this Memorandum of Understanding, the term ”
medical products ” includes medicinal products and medical
devices.

The Parties agree to cooperate on equal and reciprocal terms and
ensure that there is adequate exchange of information concerning
pharmaceuticals and medical devices to the benefit of the
Parties.

This Memorandum of Understanding will be implemented directly
between TFDA and BASG/AGES. Each Party will designate competent
agents as contact point to enhance information-sharing between
the Parties in dealing with safety of medical products that may
constitute a public health emergency of international concern on
request. The sharing information may include the each Party ’ s
policies, practices, standards, manufacturing quality,
laboratory testing, pre-market assessment, post-market
vigilance/surveillance, inspection reports, market compliance
and requirements for the regulation of medical products. Each
Party is responsible for its own expenses for the above
collaboration.

This Memorandum of Understanding shall enter into force upon the
date of the later signature and remain effective until
terminated by either Party upon 365 days prior notice in writing
to the other Party. This Memorandum of Understanding may be
modified by written agreement between the Parties.

This Memorandum of Understanding is done in duplicate in the
English language.

For the Taiwan Food and For the Austrian Agency
Drug Administration for Health and Food Safety

Dr. Jaw-Jou Kang Dr. Heinz Fruhauf CEO,
Director-General, TFDA AGES

Date: For the Austrian Federal
2013.06.19 Office for Safety in Health
Place: Taipei Care Dr. Marcus Mullner
Head AGES Division
Medizinmarktaufsicht
Operational officer BASG
Date: 2013.07.09
Place: Vienna