global product registrationto fill your requests. please be as specific as you can in what you need....

GLOBAL PRODUCT REGISTRATION

Distributor TrainingLeo Catt, Sr Regulatory Specialist

AGENDA

• Roles and Responsibilities

• Request Process Flowchart

• System Requirements

• Form elements and submitting a request

• Form questions

• Pending Registration Flowchart

• Tips and Tricks

Copyright © 2018 by DJO, LLC – CONFIDENTIAL 2

ROLES AND RESPONSIBILITIES


Group Responsibility

Distributor• Requesting documents for the purposes of product registration.• Presenting documentation to the government body for the purposes of

product registration.

Regulatory Affairs

• Fielding registration requests.• Tracking registration status and workflows.• Collecting and preparing proper documentation to present to government

bodies.• Tracking received registration certificates and initiate renewal processes.

Regional Sales Managers (RSM)

• Field business from international customers to justify registrations for that country.

• Approve registration requests that come from distributors.• Estimate revenue resulting from registrations.

SYSTEM REQUIREMENTS

• Any Modern Web Browser

• Email Client

• Access to https://www.djoglobal.com/distributor-request


GPR – Approval Process


Start Process Request GPR

NO

End ProcessEmail NotificationOf Rejection

Approve Request

Notification – Sales Manager &

DistributorYES Process Moves to

RAEmail Notification

of Approval

Email Notification of Rejection

THE PRODUCT REGISTRATION REQUEST FORM ELEMENTS


Web Address: https://www.djoglobal.com/distributor-request

https://www.djoglobal.com/distributor-request/

DISTRIBUTOR ID / REGISTRATION TYPEDISTRIBUTOR ID / REGISTRATION TYPE


Field DefinitionDistributor ID Security field –

for now, Populate with “N/A”

Registration Type Request Types

New Registration – Products Registered for the first time.

Renewal Registration – Registered products needing a renewal of the registration Certificate.

Tender – Bid for business within a country.

Custom Clearance – Documentation for Customs to let product in a country.

Factory Inspection – Documentation for QMS 13485 regulation.

DISTRIBUTOR INFORMATION


Field DefinitionDistributor Name

Name of Distributor Company or Person.

Distributor Email

Contact Email for the Distributor.

Distributor Phone

Contact Phone Number for the Distributor.

Country to be registered

Country the product will be registered.

Method of delivery

The Method in which documents will be delivered to the distributor.

By Checking the “Ship to” box, the “Ship to Address” text box will appear.

REGISTRATION AGENT INFORMATION


Field DefinitionRegistration Agent Contact Company Name of

the Registration Agent.

Registration Agent Address

Address of the Registration Agent.

Registration Agent Contact Person

Registration Agent Contact Name.

Registration Agent Country

Home country to the Registration Agent.

Registration Agent Email

Registration Agent Contact Email.

Registration Agent Phone

Registration Agent Contact Phone Number.


Field DefinitionProduct Model to be registered

Search box to find the product intended to be registered.

Product model to be registered

Text box to enter SKU/Part Numbers.

Business Line

Product line of the product to be registered.

Add Another / Remove Product

Will add/remove product information sections.Product Information Guidelines

• Enter one product and set of part numbers per section.• Enter ONLY and ALL products and part numbers in this section.• Be as specific as possible. There should be no questions about

what products are to be registered.

REGISTRATION REQUIREMENTS


• If Document localization is required, check the “Product Localization Required” box.

• Justification will be needed for localization, so enter as much information as you can.

Field DefinitionLocalization Details Business justification for the localization. As

much detail as possible.

Language Any language the documentation will be translated to.

Document Localization Documents that need to be localized.

Software Software packages to be localized.

Law or Regulation Mandating Localization

Any regulations, standards, or laws that require localization.

ADDITIONAL INFORMATION AND FILE UPLOADS


• Enter all other information that is needed

to fill your requests. Please be as specific

as you can in what you need.

• Please do not enter product information or

contact information here.

• You can upload up to 5 PDF files.

• Please do not attach product, contact, or

requirement information.

We reserve the right to reject or cancel requests for any reason.

COMMUNICATIONS


• A splash page will be displayed with a successful request entry.

• Approval / Rejection mail will follow keeping you informed on progress.

QUESTIONS???


FOR QUESTIONS ON THE FORM, EMAIL [email protected]

PLEASE WORK WITH YOUR REGIONAL SALES MANAGER FOR QUESTIONS ON CONTENT, OR PRODUCTS TO REGISTER.

mailto:[email protected]

PENDING REGISTRATION PROCESS


• Documentation is gathered and

sent to the distributors for

registration.

• Agreement between your RA

Specialist and distributor the

request is complete.

• Distributor Presents to the

country’s government.

• When registration is received,

please send it to

[email protected].

YES

NO

Accept Documentation

RA Submits Documentation to

Distributor

Submit Documentation to

Health/Government

Authority

Distributor/Regulatory

Agree on Changes

Notify Regulatory of Submission

Date

Approves Registration

Receives Registration Cert. Sends Certificate

to RA Rep

New Request? Fil RequestNO

YESHealth / Government

body Accepts Documentation

NONew Request

No

Submit New Request End Process

Start Process

Process Starts Over

YES

YES

TIPS AND TRICKS


• The web address to the form is http://www.djoglobal.com/Distributor-Request. There is no link on the

website itself, please do not share this link.

• All the fields on the form with an asterisk ( * ) are required fields. Populate all required fields. Put

“N/A” for fields that don’t apply.

• Be as specific and complete as you can with your requests. If you have questions about requirements,

work with your RA Specialist to get what you need.

• Be sure to work with your Regional Sales Manager to determine which products to register before the

request.

• Be sure to work with the RA team on documentation requirements and changes.

• Please know that new requests may need to be entered for any reason.

• Be sure to keep the RA team informed about submission dates, questions on requirements, and

received certificates.

http://www.djoglobal.com/Distributor-Request