Public procurement notice: Buyer Profile
Published: 2018-10-03
Buyer: Germany Trade and Invest; Health Made in Germany
Country: DE
Contract type: Services
CPV classification: 85149000

Technical requirements: Newsletter About Important Legislative Projects in Pharmaceutical, Medical Biotechnology and In-vitro Diagnostic Industries
Companies that dispose of the necessary contacts and information to provide the following information services are invited to declare their interest for:
1) One monthly newsletter per country about important legislative projects in pharmaceutical, medical biotechnology and in-vitro diagnostic industries in Brazil, China, India, Japan, Mexico, Russia, South Korea, USA;
2) One monthly newsletter per country about important legislative projects in the medical device industry Brazil, China, India, Japan, Mexico, Russia, South Korea, USA.
German companies from the healthcare sector often receive information on upcoming or recent legislative changes in foreign markets too late. As a consequence, they might not be able to adapt their internal pro-cesses in due time and may face a decrease in sales. Therefore, the governmental initiative Health made in Germany has established a newsletter system for different healthcare markets. The newsletters shall contain all information on important legislative projects in pharmaceutical, medical biotechnology and in-vitro diagnostic industries as well as the medical device industry.
A) Monthly newsletter about important legislative projects in pharmaceutical, medical biotechnology and in-vitro industries in the above mentioned target countries.
Target group: German pharmaceutical, medical biotechnology and in-vitro diagnostic companies exporting or planning to export to the above mentioned target countries.
Summary of all newly passed and adopted legal regulations (including their status within the legislative pro-ceedings and their date of coming into force) that are or might be important for German export companies. Most relevant topics are:
— general developments in the field of regulatory affairs and in drug registration such as require-ments on GMP inspections or changes of requirements for clinical and preclinical development etc.
— the latest development of legislative projects in the pharmaceutical and medical biotechnology sector of international importance (including changes in agreements with third countries: e.g. mu-tual acceptance of registrations),
B) Monthly newsletter about important legislative projects in medical devices technology industries in the above mentioned target countries.
Target group: German medical devices companies exporting or planning to export to the above mentioned target countries.
Summary of all newly passed and adopted legal regulations (including their status within the legislative pro-ceedings and their date of coming into force) that are or might be important for German export companies. Most relevant topics are:
— general developments in the field of regulatory affairs in medical device registration and notifica-tion incl. legal and technical requirements i.e,
—— classification/Risk analysis (incl. current revised standards and classification catalogue) Tech-nical documentation for safety assessment,