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Device Marketing Authorization 

and Facility Registration

CAPT Kimberly Lewandowski-Walker

Senior Regulatory Officer

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Course Prerequisites

• Successful completion of the following MDSAP training 

modules is a prerequisite to this course:

– Introduction to the MDSAP Program

– Overview of the MDSAP Audit Process

– MDSAP: Management Process
Learning Objectives

• Explain the Device Marketing Authorization and Facility 

Registration process

• Describe the purpose of auditing the Device Marketing 

Authorization and Facility Registration process

• Discuss the expected outcomes from audit of the Device 

Marketing Authorization and Facility Registration process

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country-specific requirements and assessment of conformity 

– Links to other MDSAP processes
Learning Objectives

• Explain the Device Marketing Authorization and Facility 

Registration process

• Describe the purpose of auditing the Device Marketing 

Authorization and Facility Registration process

• Discuss the expected outcomes from audit of the Device 

Marketing Authorization and Facility Registration process

• Explain the audit tasks to include: 

– Description, Clause and Regulation

– Country-specific requirements and assessment of conformity 

– Links to other MDSAP processes
Device Marketing Authorization and 

Facility Registration process

• May be audited as a linkage from:

– The Management process 

– The Design and Development process
Learning Objectives

• Explain the Device Marketing Authorization and Facility Registration 

process

• Describe the purpose of auditing the Device Marketing 

Authorization and Facility Registration process

• Discuss the expected outcomes from audit of the Device Marketing 

Authorization and Facility Registration process

• Explain the audit tasks to include: 

– Description, Clause and Regulation

– Country-specific requirements and assessment of conformity 

– Links to other MDSAP processes
MDSAP Audit Sequence
Purpose of Auditing

• The Device Marketing Authorization and Facility 

Registration process is audited to:

– Verify that the organization has performed the appropriate 

activities regarding device marketing authorization and 

facility registration with regulatory authorities participating 

in the MDSAP
Learning Objectives

• Explain the Device Marketing Authorization and Facility Registration 

process

• Describe the purpose of auditing the Device Marketing Authorization 

and Facility Registration process

• Discuss the expected outcomes from audit of the Device Marketing 

Authorization and Facility Registration process

• Explain the audit tasks to include: 

– Description, Clause and Regulation

– Country-specific requirements and assessment of conformity 

– Links to other MDSAP processes
Expected Outcomes

As a result of the audit of the Device Marketing Authorization and Facility Registration process, objective evidence will show whether the 

organization has: 

(A) Complied with requirements to register and/or license device facilities

(B) Submitted device listing information to regulatory authorities when

applicable

(C) Obtained device marketing authorization in the appropriate jurisdictions

(D) Arranged for assessment of changes (where applicable) and obtained

marketing authorization for changes to devices or the quality management

system which require amendment to existing marketing authorization
Learning Objectives

• Explain the Device Marketing Authorization and Facility 

Registration process

• Describe the purpose of auditing the Device Marketing 

Authorization and Facility Registration process

• Discuss the expected outcomes from audit of the Device 

Marketing Authorization and Facility Registration process

• Explain the audit tasks to include: 

– Description, Clause and Regulation

– Country-specific requirements and assessment of conformity 

– Links to other MDSAP processes
Task 1

1. Verify the organization has complied with regulatory 

requirements to register and/or license device facilities and 

submit device listing information in the appropriate 

jurisdictions where the organization markets or distributes 

their devices.

Clause and Regulation: [ISO 13485:2016: 4.1.1; 4.2.1, 5.2, 7.2.1, 

7.2.3]

MDSAP Audit Approach
Task 1

• Additional country-specific requirements: 

Australia (TGA); Brazil (ANVISA); Canada (HC); Japan (MHLW); and United States (FDA)

• Assessing conformity:

– Review labeling for product being supplied to a particular 

jurisdiction

Detailed Information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 2: Device 

Marketing Authorization and Facility Registration under task 1

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Task 1

• Links:

– Management

During audit of the Management process:

o Confirm that management is aware of and has 

made arrangements for device marketing 

authorization and facility registration
Task 2

2. Confirm the medical device organization has received

appropriate marketing clearance or approval in the regulatory

jurisdictions where the organization markets their devices.

Clause and Regulation: [ISO 13485:2016: 4.1.1, 4.2.1, 5.2, 

7.2.1, 7.2.3]

MDSAP Audit Approach
Task 2

• Additional country-specific requirements: Australia (TGA); Brazil (ANVISA); Canada (HC); Japan (MHLW); 

and United States (FDA)

• Assessing conformity:

Information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 

2: Device Marketing Authorization and Facility 

Registration under task 2

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Task 2

• Links: 

– Management

– Design and Development 

During the audit of the Management and Design 

and Development processes:

o Ensure that management is aware of requirements for 

device marketing authorization and facility registration,

o Ensure that these are considered when designing the 

device.

o Confirm that management obtains marketing 

authorization in the appropriate jurisdictions prior to 

commercial distribution of the device
Task 3

3. Verify the organization has identified changes to marketed 

devices or the quality management system which require 

notification to regulatory authorities. 

The audit team should pay special attention to situations 

observed in the audit of the Design and Development process 

(specifically design changes) that may require notification to 

the jurisdictions to which the changed devices are marketed. 

Clause and Regulation: [ISO 13485:2016: 4.1.1, 4.2.1, 5.2, 7.2.1, 

7.2.3, 7.3.9; ]

MDSAP Audit Approach
Task 3

• Additional country-specific requirements: Australia 

(TGA); Brazil (ANVISA); Canada (HC); Japan (MHLW); 

and United States (FDA)

• Assessing conformity:

Information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 

5: Design and Development, under task 3.

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Task 3

•Links:

–Design and Development 

 During the audit of the Design and 

Development process the audit team should:

o Confirm the organization has considered 

regulatory requirements for device marketing 

authorization and facility registration

o Confirm the organization has complied with 

requirements prior to marketing the changed 

device in the applicable regulatory jurisdictions 
Summary

• The Device Marketing Authorization and Facility 

Registration process may be audited as a linkage from 

the Management process or the Design and 

Development process.
Conclusion

This concludes the training module for MDSAP process: 

Device Marketing Authorization and Facility Registration.
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