International Regulatory Compliance Information

This is a sample page that shows how you could display your company's international regulatory compliance information on your website. Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. Please note that this does make some information more readily accessible to your competitors especially if there are questions regarding the classification of your devices or if you would prefer not to disclose the regulatory information that could be obtained from the documents. Most links shown below do not function and are for illustration purposes only. You should modify this page to suit the specific needs of your company.

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. View our Establishment Registration on the FDA website

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

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

UNITED STATES - FDA 510(k) cleared/PMA approved devices (Links to US FDA database device listing)
Device 1 | Device 2 | Device 3 | Device 4

MATERIAL SAFETY DATA SHEETS

Device 1 | Device 2 | Device 3 | Device 4

PRODUCT PATENTS

Device 1 | Device 2 | Device 3 | Device 4

GLOBAL REGULATORY REPRESENTATIVES

Shown below are in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here. NOTE: Emergo Group 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, Sydney, Australia
Telephone: +61.2.9006.1662
http://www.emergogroup.com/services/australia/australia-tga-sponsor

BRAZIL - ANVISA Registration Holder
Emergo Brazil, Brasilia, Brazil
Telephone: +55 61 3386 3166
http://www.emergogroup.com/services/brazil/brazilian-registration-holder

CHINA - Legal Agent & After Sales Agent
Emergo China, Beijing, China
Telephone: +86.10.8260.9560
http://www.emergogroup.com/services/china/legal-after-sales-agent

EUROPE - Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
http://www.emergogroup.com/services/europe/european-authorized-representative

INDIA - Authorized Agent
EMERGO (INDIA) CONSULTING PVT LTD, Secunderabad, INDIA
Telephone: +91 40 4018 0602
http://www.emergogroup.com/services/india/indian-authorized-agent-representative

ISRAEL - Registration Holder
I.L EMERGO ISRAEL LTD., Yoqneam, ISRAEL
Telephone: +972 (0)7753 61147
http://www.emergogroup.com/services/israel/israel-registration-holder

JAPAN - Designated Marketing Authorization Holder (MAH)
Emergo Japan K.K., Tokyo, Japan
Telephone: +81.3.3350.9656
http://www.emergogroup.com/services/japan/dmah-representation

MEXICO - Registration Holder
EMERGO MEXICO, Mexico City, MEXICO
Telephone: +52.55.55.33.08.32
http://www.emergogroup.com/services/mexico/mexico-registration-holder

SOUTH KOREA - Third Party License Holder
EMERGO KOREA LIMITED, Seoul, KOREA
Telephone: +82 70 8679 3039
http://www.emergogroup.com/services/korea/korea-third-party-license-holder

RUSSIA - Declarant
EMERGO (RUSSIA) CONSULTING LLC., Moscow, RUSSIA
Telephone: +7 916 371 77 17
http://www.emergogroup.com/services/russia/russian-declarant

USA - FDA Agent
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
http://www.emergogroup.com/services/us/us-fda-agent