YOUR COMPLIANCE JOURNEY FOR OTHER PRODUCTS (PPE, Machinery, Toys, GPSD/GPSR, etc.)
You Are Invited to Join an EXCLUSIVE Club
1. Your RA consultant will send you Annex A – List of products.
2. Customer Relations dept. will share the Order Form to cover compliance process.
3. Accounting dept. will share with you the related invoice.
PRE-COMPLIANCE PROCESS
What will Obelis do?
1. To fully complete & sign & send back Annex A to Obelis.
2. Carefully review the Order Form & add signature & send it back to Obelis.
3. Settle the payment of the invoice.
What we need from you?
1. Send you instructions letter on the needed documentation.
2. Grant access to the online Repository
3. Review your documentation as per applicable regulatory requirements.
4. Provide feedback on your documentation.
COLLECTION OF NECESSARY DOCUMENTATION
What will Obelis RA consultant do?
What we need from you?
1. To upload all the necessary documentation to the Repository.
2. Inform us once the upload of the documentation is complete.
3. Provide updated documentation implementing feedback given by your RA consultant.
1. Send you Certificates’ specimens for review.
2. Upon confirmation, we will send you finalized Certificates per email.
OBELIS CERTIFICATE ISSUANCE
What will Obelis RA consultant do?
1. Remain available for any questions, queries.
2. Send you regulatory updates through PRODlaw.
ACCESS TO THE MARKET
What will Obelis RA consultant do?
What you need to do?
1. Translate your labels & IFUs – when applicable.
2. Inform us of any changes to your documentation.
STEP 1
STEP 2
STEP 3
STEP 4
What we need from you?
1. Review specimens & confirm the information.
Get familiar with the steps & timeline!
Not sure about your process?
Not sure about your process?
Obelis Group
Boulevard Brand Whitlock 30, Brussels, 1200, Belgium
Tel: +3227325954
Fax: +3227326003
sales@obelis.net
© Obelis Group 2023
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