CSDT format for ASEAN community - Manufacturer Information requirements

L

LQ. Fanny Lozano

#1
Hi everyone,

On the CSDT guide for medical devices, on section 4.6 Manufacturing process it is mentioned that "Quality Management System certificates (QMS) must be presented for all manufacturing sites...Are these certificates the same as GMP certificates or equivalent? or they are quite appart from GMP certificates?

Help please!! :confused: Thank you so much!!
 
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#2
Hi,

You need submit ISO 13485 Certificate and Manufacturing Process Flow Chart.
If you hv multiple sites, you need to tabulate the products, part number, description and manufacturing site.

Hope this helps.

Regards,
Sreenu
 
#4
Are these certificates the same as GMP certificates or equivalent? or they are quite appart from GMP certificates?

--> Yes, similar to GMP or ISO 13485 certificate from subcontractors. In additional, they must also submit their master files, too. For example, your products use outsources for sterilization, you must have these subcontracts submit their master file including validation, process flow and GMP/ISO 13485 certificate, etc. to FDA.
 
Thread starter Similar threads Forum Replies Date
L Device Description in CSDT Format - Medical Device Instructions for Use (IFU) Other Medical Device Regulations World-Wide 6
G Singapore Distributor - IVD requirement for CSDT/STED documents Other Medical Device Regulations World-Wide 2
E STED (Summary Technical Document) and CSDT Differences Other Medical Device Regulations World-Wide 6
M Always Date format with letters After Work and Weekend Discussion Topics 17
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
D Safety Assurance Case Report Format ISO 14971 - Medical Device Risk Management 4
S Issuing of CoC to Customer in a Word or Excel format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Which OEM or customers are now requiring the new AIAG/VDA FMEA format? FMEA and Control Plans 2
N How to Extract LxWxH from JT format ? Lean in Manufacturing and Service Industries 0
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 0
B AIAG-VDA FMEA - When the new format will be required FMEA and Control Plans 5
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
F ISO 17025:2017 Format for Procedure and Records Document Control Systems, Procedures, Forms and Templates 3
P GM TWO (Temporary Work Order) - Is there a specific GM format for the TWO# to be sent with the material? IATF 16949 - Automotive Quality Systems Standard 1
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
S New AIAG FMEA Process - How to complete the new format FMEA and Control Plans 32
A Usable version of MDR in Word format CE Marking (Conformité Européene) / CB Scheme 0
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
D FDA Date Format Requirement US Food and Drug Administration (FDA) 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
PastorBee13 IATF 16949 Audit Nonconformance Responses per 5.1.1.2 - Format IATF 16949 - Automotive Quality Systems Standard 11
M Medical Device News FDA News - 12-09-18 - MD Submissions to Electronic Format to Improve Efficiency Other US Medical Device Regulations 0
C Excel date format from Denmark to USA Excel .xls Spreadsheet Templates and Tools 6
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A AS9100 Rev D - Procedure for Product Safety & Control of Counterfeit Part (Format) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E MDSAP and Procedure Format ISO 13485:2016 - Medical Device Quality Management Systems 2
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
1 KPI Dashboard Template in Excel Format wanted Excel .xls Spreadsheet Templates and Tools 9
C Manufacturing Process Work Instructions - Format Manufacturing and Related Processes 4
H GHTF and IMDRF - Alternative for the STED format EU Medical Device Regulations 5
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T ISO 9001:2015 Clause 9.2.2 Internal Audit - Corrective Action Report Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C PPAP Rejection for "MSA-GR&R are not using the latest AIAG format" APQP and PPAP 9
H Part 147 AMTO Audit Plan example and Audit Report Format wanted EASA and JAA Aviation Standards and Requirements 1
V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
S ISO 9001:2015 clauses and clause details in Excel format Document Control Systems, Procedures, Forms and Templates 11
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
C 510(k) STED Format - Feedback from users US Food and Drug Administration (FDA) 1
Q FDA - Annual Report Submission Format and QMS updates Other US Medical Device Regulations 2
H Control plan example format for CNC machining activities FMEA and Control Plans 3
somashekar Time and Date Format - ISO 8601:2004 Other ISO and International Standards and European Regulations 1
drgnrider Is there a specific OHSAS 18001 sign format? Occupational Health & Safety Management Standards 4
T Excel Conditional Format Issue Excel .xls Spreadsheet Templates and Tools 16
K FMECA (Critical Analysis) Format and Ranking Table AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Predictive Maintenance Format / Example Misc. Quality Assurance and Business Systems Related Topics 4
K Sample format for Equivalency Protocol /Report Using Minitab Software 5

Similar threads

Top Bottom