{{ phone }} {{ location }}

Emergo by UL logo

         

Sample Regulatory Page for Medical Device Manufacturers

Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. Shown below is an example of how you could display your company's international regulatory compliance information on your website. 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)

US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registration on the FDA website

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

ABC Medical Devices maintains ISO 13485 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

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

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 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 
EMERGO AUSTRALIA, Sydney, Australia
Telephone: +61.2.9006.1662
https://www.emergogroup.com/services/australia/australia-tga-sponsor

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

EUROPE -  Authorized Representative
EMERGO EUROPE, The Hague, The Netherlands
Telephone: +31.70.345.8570

https://www.emergogroup.com/services/europe/european-authorized-representative

INDIA -  Authorized Agent
EMERGO (INDIA) CONSULTING PVT LTD, Secunderabad, India
Telephone: +91 40 4018 0602

https://www.emergogroup.com/services/india/indian-authorized-agent-representative

ISRAEL - Registration Holder
I.L EMERGO ISRAEL LTD., Haifa, Israel
Telephone: +972 (0)7753 61147

https://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

https://www.emergogroup.com/services/japan/dmah-representation

MEXICO - Registration Holder
EMERGO MEXICO, Mexico City, Mexico
Telephone: +52.55.55.33.08.32

https://www.emergogroup.com/services/mexico/mexico-registration-holder

SOUTH KOREA - License Holder
EMERGO KOREA LIMITED, Seoul, South Korea
Telephone: +82 70 8679 3039

https://www.emergogroup.com/services/south-korea/korea-license-holder-for-mfds

RUSSIA - Authorized Representative
EMERGO (RUSSIA) CONSULTING LLC., Moscow, Russian Federation
Telephone: +7 916 371 77 17

https://www.emergogroup.com/services/russia/authorized-representative-russia

UNITED STATES - US Agent
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997

https://www.emergogroup.com/services/united-states/us-fda-agent