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

                                                                 

ID: GP-MD-VIA-SR
Category: Medical Devices
Validity: Until Change or local NRA
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
                                                            

SUMMARY

As per FDA device classification, Class I medical devices which fall under the low risks category do not require premarket approval from FDA. However, the device must be registered on the FDA website and must comply with Labeling requirements. Some class I medical devices that fall under the moderate risk category are required for FDA clearance in terms of premarket notification 510(K).
The sponsor should determine which category the device belongs to in EU NRA (EMA). If the device belongs to class I, non-sterile, and non-measuring, then a QMS is not formally required. However, a Post-Market Surveillance (PMS) procedure is required though not audited by a Notified Body (NB, further NRA). 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. For those devices that belong to other classes, Quality Management System (QMS) is required, and most companies apply for ISO 13485 standards to achieve QMS compliance. For class I, non-sterile, and non-measuring, there is an audit or MDR/IVDR technical file required.
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 I Simplified Regulations Card Gantt Chart (1) Page 0001 (2)

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • Device description, including variants
  • Technical documentation (MDR/IVDR)
  • Instructions for use (IFU)
  • Quality Management System (QMS)
  • 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
  • Regulatory Compliance and Gap Analysis see GP-PhR-GAP-SR card
  • Regulatory Intelligence and Strategic Consulting see GP-PhR-RI-SR card

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

NRA Official Response

NRA

week 24

1

    

  III.7

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

NRA

week 25

1

   

Approval

IV

Approval

       

  IV.1

NRA/NB Conclusion draft verification

Executor

week 26

1

    

  IV.2

NRA Conclusion publication

NRA

week 27

1

    

  IV.3

State Listing update

Executor

week 28

1

    

  IV.4

Reporting  to MAH

Executor

week 29

1

   

Report

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 30

1

    

  F.2

Final Invoice

Executor

week 30

1

    

  F.3

Final Payment

MAH

week 31

1

    

  F.4

Contract Termination

Executor

week 31

1

    

  F.5

Archiving and limiting access

Executor

week 32

1

   

Archiving

 

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