Procedure: New Market Authorization Class III
Country: Global Procedure
Version #: 01/08/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

                                                                 

ID: GP-MD-VIII-SR
Category: Medical Devices
Validity: For 5 years (US), CE mark valid for 3 years (EU)
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Class III medical devices are fall under the highest risks category. In USA once the device has been classified as Class III, the manufacturer must submit a Premarket Approval (PMA) application to the FDA. This application must include data from clinical studies demonstrating the device’s safety and effectiveness, as well as detailed information about the device’s design, manufacturing, and labeling, and fully documented quality system compliant with design controls. The FDA may request additional information or clarification from the manufacturer. The approval process for Class III medical devices can be lengthy and complex, and it may take several years for a device to go through the entire process. However, the FDA has several expedited review programs in place to help bring promising medical technologies to market more quickly. In Europe once the device has been classified as Class III, the manufacturer must obtain a CE mark, which indicates that the device meets all relevant EU regulatory requirements. To obtain a CE mark, the manufacturer must complete a conformity assessment procedure, which typically includes a technical file review and a clinical evaluation. The technical file review is similar to the Premarket Approval (PMA) process in the US and requires the manufacturer to provide detailed information about the device’s design, manufacturing, and labeling. The clinical evaluation assesses the device’s safety and effectiveness based on data from clinical studies and other relevant sources. Class III MA requires manufacturers to monitor the safety and performance of their devices and report any adverse events or field safety corrective actions to the National Regulatory Authorities (NRAs).
Gp Medical Devices New Market Authorization Class Iii Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • Device description, including variants
  • Technical documentation (MDR/IVDR)
  • Instructions for use (IFU)
  • Quality Management System (QMS/QSR)
  • Good Manufacturing Practice (GMP)
  • Declaration of Conformity (DoC)
  • Risk Management
  • Clinical Evidence
  • POA
  • Substantially equivalent to the predicate device
  • MAs in other countries
  • CE mark and ISO 13485 in many countries

Nice-to-have:

  • IEC 60601
  • ISO 14971
  • ISO 10993
  • Labeling

Typical Gaps and Deficiencies: Understanding of the regulatory pathway and requirements applicable to the device. Incorrect predicate device selection. Inadequate documentation. Rush in submitting the application without being prepared                                           

Implementation Period: Immediately upon approval                                                          

Deliverables: Market Authorization (Clearance or Registration), NRA Listing and Establishment registration

PHASE

TASK

TASK

START

DURATION

 

Fee

 

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

 

0

In-house Pre-Submission Activity

       

  0.1

NDA signing or validation

Executor

week 1

1

    

  0.2

Contract Closing

MAH

week 1

1

    

  0.3

SOW is approved by MAH

MAH

week 1

1

   

SOW

  0.4

POA issuance and shipping

MAH

week 2

1

    

  0.5

Invoice is sent to MAH and paid

MAH

week 3

1

   

POP

I

Prep and Submission

       

  I.1

Predicate device equivalence, admin. & info set review

Executor

week 4

1

    

  I.2

Classify the device (exemption review)

Executor

week 5

1

    

  I.3

Technical Documentation review vs. NRA requirements

Executor

week 6

2

    

  I.4

Application and supplement documents development

Executor

week 8

2

    

  I.5

Approval of the Application

MAH

week 10

1

    

  I.6

NRA payment

MAH

week 10

1

    

  I.7

Submission of the Application

Executor

week 11

1

   

Submission

II

Studies

       

  II.1

Сonducting technical, toxicology, electrical, and software tests, as well clinical and suitability studies, if required

Executor

week 12

4

   

Reports

III

Review and Evaluation

       

  III.1

NRA Application review

NRA

week 16

2

    

  III.2

NRA Technical file review

NRA

week 18

2

    

  III.3

NRA Lab tests and clinical evaluation review

NRA

week 20

2

    

  III.4

NRA Addressing clarifications or queries if so

NRA

week 22

1

    

  III.5

Answering with relevant documents from MAH

Executor

week 23

1

    

  III.6

Facility Inspection if required

NRA

week 24

4

    

  III.7

NRA Official Response

NRA

week 28

1

    

  III.8

NRA Approval (GoTo Ph. IV) or Query (Rpt. Ph. III.5)

NRA

week 29

1

   

Approval

IV

Approval

       

  IV.1

NRA/NB Conclusion draft verification

Executor

week 30

1

    

  IV.2

NRA Conclusion publication

NRA

week 31

1

    

  IV.3

State Listing update

Executor

week 32

1

    

  IV.4

Reporting  to MAH

Executor

week 33

1

   

Report

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 34

1

    

  F.2

Final Invoice

Executor

week 34

1

    

  F.3

Final Payment

MAH

week 35

1

    

  F.4

Contract Termination

Executor

week 35

1

    

  F.5

Archiving and limiting access

Executor

week 36

1

   

Archiving

 

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