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CFS Form Reference No:
CFS Reference No:
Id
Submission ID
Please refer to the respective Guidance Document located on the Malta Medicines Authority Website.
SECTION A: APPLICATION INTRODUCTION
Date of Application (Auto Fill):
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Applicant Name and Surname
Applicant Email Address
Applicant Contact Number
Applicant Type
SECTION B: MANUFACTURER DETAILS
Manufacturer Organisation Name
Manufacturer Telephone Number
Manufacturer Address
Type a value
Manufacturer Contact Name
Manufacturer Email Address
Manufacturer Job title
Manufacturer Malta Business Registry Company Number
SECTION C: AUTHORISED REPRESENTATIVE (AR) DETAILS
AR Organisation Name
AR Telephone Number
AR Address
Type a value
AR Contact Name
AR Email Address
AR Job Title
AR Malta Business Registry Company Number
SECTION D: INFORMATION ON CERTIFICATE OF FREE SALE
Type of Medical Device (tick as applicable):
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Devices to be included in Certificate of Free Sale
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Download MT-MDF01 Excel Sheet
SECTION E: DOCUMENTS
Proof of Manufacturer (Notarised Document)
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Notified Body Certificates for relevant device/s
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SECTION F: DETAILS OF PAYMENT
Payment type
Proof of Payment attached
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Data Protection Consent Statement
ADDITIONAL DOCUMENTATION
I have attached a copy of the Malta Business Registry Certificate of Company Registration.
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I have attached mock-ups of the label, packaging and instructions for use.
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For Authorised Representatives: I have provided evidence by attaching a copy of the mandate as per MDR Article 11(3)
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DECLARATION FOR FORM SUBMISSION
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Download Declaration Form
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