SBS - The best value in QMS software

Is it compulsory to update the obsolete GMDN codes in ARTG?

Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2

Attachments

Ronen E

Problem Solver
Staff member
Moderator
#3
Is it compulsory to update the GMDN obsolete codes in ARTG? And, what are the benefits?
As to it being “compulsory”, you would have to consult your lawyer.
...or the TGA, or your regulatory consultant...

The key sentence in John's link above is:
TGA does not require the sponsor to amend the GMDN code if it becomes obsolete.
 

MEa

Registered
#5
Thanks, John!I It seems the GMDN codes change quite often and without being a member of the GMDN it is difficult to keep on top of it.
 
Thread starter Similar threads Forum Replies Date
G Is it compulsory to make DFMEA for proto parts making organisation APQP and PPAP 1
H Is Product Liability Insurance Compulsory for Medical Device Manufacturers? Other Medical Device Regulations World-Wide 2
K ISO 14001 Clause 4.3.3 - Compulsory Objectives ISO 14001:2015 Specific Discussions 1
R UL & CCC (China Compulsory Certification Mark) Certification Requirements Various Other Specifications, Standards, and related Requirements 1
P Is it compulsory to send new measuring equipment for calibration / verification? Calibration Frequency (Interval) 3
K Calibration Stickers on Measurement Equipment - Compulsory or not General Measurement Device and Calibration Topics 23
N Is it compulsory to print the CE mark on our software & user manual CD-ROM EU Medical Device Regulations 3
E Is ISO 13485 compulsory - Fabrication of precision metal parts for medical industry? ISO 13485:2016 - Medical Device Quality Management Systems 17
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
M ENEC Mark - How is it related to the CE Mark and is it Compulsory? CE Marking (Conformité Européene) / CB Scheme 3
C Is NCR compulsory for all Nonconformances found during Internal Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L Introduction of Compulsory Bar Coding of Medical Devices in the US? ISO 13485:2016 - Medical Device Quality Management Systems 19
P CCC (China Compulsory Product Certification) - Registration bodies in North America? Various Other Specifications, Standards, and related Requirements 6
A When will ISO13485 Update be Released? EU Medical Device Regulations 1
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
M Trigger to update of TLL VDA Standards - Germany's Automotive Standards 0
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom