International Regulatory Compliance Information
This is a sample web page that shows how you could display your company's international regulatory compliance information. Having a dedicated regulatory compliance page is useful to prospective customers, end users, potential distributors and regulatory officials. Most links shown below do not function and are for illustration purposes only.
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
PRODUCT CERTIFICATIONS AND APPROVALS
AUSTRALIA - Devices listed in ARTG (Links to TGA website)
Device 1 | Device 2 | Device 3 | Device 4
CANADA- Medical device licenses (Links to Health Canada website)
Device 1 | Device 2 | Device 3 | Device 4
EUROPE - CE Marking certificates (PDF format)
Device 1 | Device 2 | Device 3 | Device 4
EUROPE - Declarations of Conformity (PDF format)
Device 1 | Device 2 | Device 3 | Device 4
NOTE FROM EMERGO: Classification information on your device is not publicly available so consider the implications of including it on your website.
UNITED STATES - FDA 510(k) cleared/PMA approved devices (Links to US FDA database device listing)
Device 1 | Device 2 | Device 3 | Device 4
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here. NOTE: Emergo is listed as the representative for all regions below. You should, of course, list the appropriate representative for your company in each region.
AUSTRALIA - Sponsor Representative
Emergo Australia Pty. Ltd., Sydney, AUSTRALIA
Telephone: +61.2.9006.1662
http://www.EmergoGroup.com
CHINA - Legal Agent & After Sales Agent
Jyton & Emergo Co. Ltd., Beijing, CHINA
Telephone: +86.10.8260.9650
http://www.EmergoGroup.com
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
JAPAN - Designated Marketing Authorization Holder
Emergo Japan K.K., Tokyo, JAPAN
Telephone: +81.3.3350.9656
http://www.EmergoGroup.com
UNITED STATES - US Agent representative
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
http://www.EmergoGroup.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
ABC Medical Devices maintains ISO 13485:2003 certification and is audited every year by:
AAA Auditing Services
Anytown, USA
Telephone: +1.555.555.1234
Website link
MATERIAL SAFETY DATA SHEETS
Device 1 | Device 2 | Device 3 | Device 4
PRODUCT PATENTS
Device 1 | Device 2 | Device 3 | Device 4
