Export Registration and Appproval

We have Experienced and Enthusiastic Professionals that help your Organization to get registered for Facility and Devices as per various Country Regulations in Shortest Possible Time and Cost-effective Way.

EXPORT REGISTRATIONS

USA

• FDA Establishment Registration
• FDA Device Listing for Class I (510(k) Exempt Devices)
• FDA 510(k) Approval
• CFG USFDA

EUROPE

• EU FSC
• Product Registrations in EU Countries.

AFRICAN COUNTRIES:

Ghana, Nigeria, Benin, Burkina Faso, Central African Republic, Congo, Egypt, Ethiopia, Gabon, Liberia, Malawi, Morocco, Rwanda, Sierra Leone, Sudan, Tanzania, Togo, Cameroon, Uganda, Kenya, South Africa.

GULF / MIDDLE EAST COUNTRIES:

Bahrain, Kuwait, Saudi Arabia, Syria, Qatar, Dubai, Oman, Iran

ASIAN COUNTRIES:

Bangladesh, Malaysia, Indonesia, Nepal, Sri Lanka, Philippines, Singapore, Thailand, Vietnam, Korea.

RUSSIA / CIS:

Russia, Ukraine, Uzbekistan, Belarus, Azerbaijan, Turkmenistan

LATIN AMERICAN:

Mexico, Columbia, Argentina

 

Our professionals help you in

• Developing Your Organization Quality Management System as per 21 CFR 820, ISO 13485
• Developing Complete Quality System Documentation.
• Assisting in Preparation of Technical Document for Your Device.
• Identifying Tests Required for Your Device
• Liaison with the Authorized Distributor/Agent of Your Company in that Country for speeding up the Registration Process.
• Preparation of Application and Submission.
• Getting Registration. Ask for quotation...