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

                                                                 

ID: GP-MD-VII-SR
Category: Medical Devices
Validity: For five years
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
                                                            

SUMMARY

Class II medical devices are fall under the moderate risks category. Manufacturers must follow a set of regulatory requirements to bring a class II medical device to market. In the USA they must submit a premarket notification, or 510(k), to the FDA demonstrating that the device is substantially equivalent to a device that is already on the market. However, if the FDA determines that a device is not substantially equivalent or if it raises concerns about the device’s safety or effectiveness, it may require additional clinical testing or other data before it can be cleared for sale. In addition to the premarket review process, class II medical devices are also subject to Post-Market Surveillance (PMS). This means that manufacturers must continue to monitor their devices and maintain records after they are on the market and report any adverse events or problems to the FDA. In Europe, there are Class lla and Class IIb-type medical devices classified as low-moderate risk and high-moderate risk devices. Under the MDR, manufacturers of class II medical devices must obtain a CE mark to sell their products in the EU. Manufacturers must complete a conformity assessment procedure to obtain a CE mark and submit a technical file to a Notified Body (NB) to review the technical file and determine whether the device meets the relevant requirements. Market authorization (MA) requirements vary by country, and compliance with local regulations is crucial. It typically involves demonstrating that the device meets safety and performance standards set by the respective health authorities.
Gp Medical Devices New Market Authorization Class Ii 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

 

Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com