Dossier ID request form for medical devices

Manufacturer Company ID (6 numbers) (required)^{Footnote 2}

Manufacturer Contact ID (5 numbers) (required)^{Footnote 2}

Regulatory Company ID (6 numbers) (required)^{Footnote 2}

Regulatory Contact ID (5 numbers) (required)^{Footnote 2}

Device Class (required)^{Footnote 3}
Class II
Class III
Class IV

Regulatory Activity Type (required) ^{Footnote 4}
Minor Change
Licence
Licence Amendment
Private Label
Private Label Amendment

Licence Number (6 numbers, input N/A if the Regulatory Activity Type is 'Licence') (required)^{Footnote 5}

Name of Device, as it appears on the label (required)^{Footnote 6}

MDSAP Auditing Organization (select 'Not Applicable' if the Regulatory Type is 'Private Label' or 'Private Label Amendment')
(required)
Not applicable BSI Group America Inc. Dekra Certification B.V. DQS Medizinprodukte GMBH Intertek Testing Services NA Inc. Laboratoire National de métrologie et d'Essais (LNE) - Division certification G-MED (trading as LNE/G-MED and G-MED) Lloyd's Register Quality Assurance Inc. National Standards Authority of Ireland QMI-SAI Canada Limited SGS United Kingdom Ltd. TUVRNA - TÜV Rheinland of North America, Inc. TUVAM - TÜV SÜD America Inc. (also operating as TÜV America Inc.) TUVNORD – TUV Nord Cert GMBH TUV USA - TÜV USA, Inc. UL - UL LLC

Licence Application Type (required)^{Footnote 7}
Single Device System Test Kit Device Family Device Group Device Group Family

Additional field for context

First Name (required)

Initials

Last Name (required)

Language of Correspondence (required)
English
French

Job Title (required)

Fax Number

Phone Number (required)

Phone Extension

Email (required)

First Name

Initials

Last Name

Language of Correspondence
English
French

Job Title

Fax Number

Phone Number

Phone Extension

Email