Which documents are required for a class I medical device listing

M

mghaleb

#1
#1
Hi all,

which documents are required or necessary for device listing for class I medical device?

Thanks in advance!
Ghaleb
 
Paper to QMS ad
Elsmar Forum Sponsor
bio_subbu

bio_subbu

Super Moderator
#2
#2
Re: class I device listing

mghaleb said:
Hi all,

which documents are required or necessary for device listing for class I medical device?

Thanks in advance!
Ghaleb
Click to expand...
Hi Ghaleb

Do you have a chance to refer the USFDA's webpage "Device Registration and Listing"?

Also, refer FDA's CDRH learn

1. Regulatory Overview of Device Establishment Registration and Listing

2. Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website

3. FURLS Device Registration and Listing Module Annual Registration

4. FURLS Device Registration and Listing Module for Initial Registration
 

Attachments

J

Julie O

#5
#5
You don't have to submit any documents to FDA to list your device. Instead, you enter a limited amount of information about the device into FDA's online database.

You do have to have various documents on file to support compliance with FDA's requirements for the Class I device you have listed.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Required documents for Class III Medical Device in Yemen Other Medical Device Regulations World-Wide 3
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc IAF Mandatory Documents (MD Series) - Required to be used by certification bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F The depth of the required Design Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Clarification in organizing required documents for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 6
H Is "Master Documents and Records list" required per ISO 9001 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
drgnrider Informational Required Documents/Records in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 54
x-files Documents required by the quality management system shall be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Minimum documents required by AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N What Documents are Required for each ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
T Control of Safety Documents Required? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R What Documents are required for Application of Brazilian INMETRO IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Documents required to display/keep during ISO 9000 Audit in EPCC firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
W Electronic Distribution of Controlled Documents: Validation required? Qualification and Validation (including 21 CFR Part 11) 5
J ISO 9001:2008 Clause 4.2.3 - What are the required documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
C ISO 3834-2 references ISO 3834-5 for the list of documents required for conformity Other ISO and International Standards and European Regulations 1
M All Internally Generated Documents ? Required to be Controlled or Not All? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
C Control of Documents - Is a unique format required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M List of documents required for engineering service project (CAD/CAM) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
V What documents are required for Education and Training in AS9100 Internal Auditing 3
A Documents required for ISO 17020 vs. ISO 9001? General Measurement Device and Calibration Topics 10
P Required Documents and Document Control in Human Resources for ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 5
P New product Design & Development for automotive requirements - Documents required Design and Development of Products and Processes 4
T Using References - Required in Quality Documents? Document Control Systems, Procedures, Forms and Templates 2
R Documents required for certification process - AS/EN/JISQ9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E New and revised documents - Acknowledgement of distribution required? Document Control Systems, Procedures, Forms and Templates 3
E Level 3 PPAP with only a few of the required documents? APQP and PPAP 3
O What are typical records of different documents required by ISO9001? Records and Data - Quality, Legal and Other Evidence 2
R TS16949 Grandfather documents - Control Plans - Required or not based upon date FMEA and Control Plans 4
L ISO 14001 4.4.4 d) - What exactly are the documents and records required by ISO 14001 ISO 14001:2015 Specific Discussions 3
Howard Atkins TS 16949 Clause 4.2.1 - Required Documents IATF 16949 - Automotive Quality Systems Standard 15
G Control of External Documents - Which documents are required to be controlled? IATF 16949 - Automotive Quality Systems Standard 10
C How long we're required to keep supplier and our PPAP documents? Supplier Quality Assurance and other Supplier Issues 1
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17

Similar threads

Top Bottom