“MDSAP: Device Marketing Authorization and Facility Registration

Slide 1

I am CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer at the Center for Devices and 

Radiological Health at the U.S. Food and Drug Administration. 

In this training module, we will be reviewing the Device Marketing Authorization and Facility 

Registration process for the Medical Device Single Audit Program.

Slide 2

The prerequisites for understanding this Device Marketing Authorization and Facility Registration 

Process training module are successful completion of the MDSAP training modules: “Introduction to the 

MDSAP Program”, “Overview of the MDSAP Audit Process, and “MDSAP: Management Process”.

Slide 3

In this Device Marketing Authorization and Facility Registration process training module, we will 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 the audit of this process, and Explain the audit tasks in terms of the description and related Clauses 

and Regulations for each audit task, the list of country-specific requirements and assessment of 

conformity for each audit task, and indicate the links to other MDSAP processes.

Slide 4

Let’s begin with explaining the Device Marketing Authorization and Facility Registration process.

Slide 5

The Device Marketing Authorization and Facility Registration process may be audited as a linkage from 

the Management process or the Design and Development process.

Slide 6

We will now move to discussion of the purpose of auditing the Device Marketing Authorization and 

Facility Registration process

So, why do we audit this process?

Slide 7

As you can see from this diagram, the Device Marketing Authorization and Facility Registration can be 

initially audited as a linkage from the Management process; however, you may find it necessary to 

revisit the Device Marketing Authorization and Facility Registration process if, during the audit of the 

Design and Development process, you find that the organization has made changes to their devices that 

require marketing authorization. 

Slide 8

The purpose of auditing the Device Marketing Authorization and Facility Registration process is to verify 

that the medical device organization has performed the appropriate activities regarding device 

marketing authorization and facility registration with regulatory authorities participating in the MDSAP.
Slide 9

We will now move to a discussion of the expected outcomes of auditing Device Marketing Authorization 

and Facility Registration process. The next few slides will discuss these expected outcomes.

Slide 10

As a result of the audit of the Device Marketing Authorization and Facility Registration process, objective 

evidence will show whether the organization has: complied with requirements to register or license 

device facilities; submitted device listing information to regulatory authorities when applicable; 

obtained device marketing authorization in the appropriate jurisdictions; and 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.

Slide 11

The next few slides will explain each audit tasks in terms of the Description and related Clauses and 

Regulations for each audit task, the Country-specific requirements and assessment of conformity, and 

the Links of the Device Marketing Authorization and Facility Registration process to other MDSAP 

processes.

Accomplishment of the expected outcomes for the Device Marketing Authorization and Facility 

Registration process is achieved through the completion of the audit tasks. For this process, the primary 

means of completing the audit tasks is by verifying that the organization meets the regulatory 

requirements of the various jurisdictions participating in the Medical Device Single Audit Program.

Slide 12

Task 1: Verify the medical device organization has complied with regulatory requirements to register or 

license device facilities and submit device listing information in the appropriate jurisdictions where the 

organization markets or distributes their devices.

The related clauses of ISO 13485:2016 are listed on this slide. There are no related regulations for the 

participating countries.

Slide 13

There are additional country-specific requirements for Australia, Brazil, Canada, Japan, and United 

States.

Assessing conformity includes reviewing labeling for product being supplied to a particular jurisdiction. 

Special attention should be paid to instances where products are being marketed to MDSAP jurisdictions 

that marketing authorization has not been granted. This may be evident through audit of other 

processes, such as Design and Development. Detailed information on country-specific requirements and 

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.

Slide 14

This task has a link to Management processes. During audit of the Management process, confirm that 

management is aware of, and has made arrangements for, device marketing authorization and facility 

registration.

Slide 15
Task 2: Confirm the medical device organization has received appropriate marketing clearance or 

approval in the regulatory jurisdictions where the organization markets their devices.

The related clauses of ISO 13485:2016 are listed on this slide. There are no related regulations for the 

participating countries.

Slide 16

There are additional country-specific requirements for Australia, Brazil, Canada, Japan, and the Unites 

States.

Detailed information on country-specific requirements and 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.

Slide 17

This task has linkages to Management and Design and Development processes.

During the audit of the Management and Design and Development processes, ensure that management 

is aware of requirements for device marketing authorization and facility registration, and that these are 

considered when designing the device. Confirm that management obtains marketing authorization in 

the appropriate jurisdictions prior to commercial distribution of the device.

Slide 18

Task 3: Verify the medical device 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.

The related clauses of ISO 13485:2016 are listed on this slide. There are no related regulations for the 

participating countries.

Slide 19

There are additional country-specific requirements for this task for Australia, Brazil, Canada, Japan, and 

the United States.

Detailed information on country-specific requirements and 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 3.

Slide 20

This task has links to the Design and Development process.

During the audit of the Design and Development process, the audit team should confirm the 

organization has considered regulatory requirements for device marketing authorization and facility 

registration; and has complied with these requirements prior to marketing the changed device in the 

applicable regulatory jurisdictions. 
Slide 21

In 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.

Slide 22

This concludes the training module for MDSAP process: Device Marketing Authorization and Facility 

Registration.