Do you have an SOP for communicating with regulatory authorities

Jane's

Involved In Discussions
#1
Do you have an SOP which states the steps and records required for communicating with regulatory bodies (renewing licenses, etc.)
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Just some background here, this requirement was created due to some comments = some of my comments were that I found strange that manufacturers did not have, for example, procedures on how to create submission documents and hot to submit to different regulatory authorities from target markets. Although the requirement at the end was too generic to my taste, I hope that people understand that it's not one "SOP for communicating with regulatory authorities" that would comply with this requirement.
 

Jane's

Involved In Discussions
#3
Hi Marcelo,

Wouldn't one SOP with sections for different reg authorities be a good way to start? Many small companies have one or two or three regions/countries they sell to.
 

Marcelo

Inactive Registered Visitor
#4
Hi Marcelo,

Wouldn't one SOP with sections for different reg authorities be a good way to start? Many small companies have one or two or three regions/countries they sell to.
It would be a good start, surely; what I tried to say is that this is one requirement that people should avoid creating only one generic procedure for "communicating with regulatory authorities" as a mean to pass the audit only.
 

Jane's

Involved In Discussions
#5
Agreed.

Just for added clarity, if relevant, my question was triggered by a blog I was reading about ISO 13485 2003 and 2016 differences. If you don't mind pointing me to the discussion you had on this topic previously that would be great.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Here is a procedure for you:
1. Identify the relevant authority for the jurisdiction of interest.
2. Go to that authority’s website.
3. Follow the instructions provided through the website on how to be in compliance and how to complete individual tasks at hand (eg registration).
4. If there’s no website or no relevant information can be found in it, apply your common sense and resourcefulness to collect the relevant information from other sources.
5. Failing 4, ask to be moved to another position, as you apparently lack one of the basic abilities for this kind of position.

Anything vastly differing from the above would be - in my opinion - superfluous and inefficient because the information is mostly available online and it keeps changing.
 

rob73

looking for answers
#7
Jane
Our manual simply states:
[FONT=&quot]Reporting to Regulatory Authorities[/FONT]

Upon receipt of adverse incident complaint the specific reporting requirements of the jurisdiction reporting will be reviewed and the relevant regulatory authority will be contacted and appropriate advisory notices or reporting shall take place.
A current list of national regulatory authorities and contact points will be held.
Records of reporting to regulatory authorities shall be maintained (see 4.2.5).


We have a list of worldwide authorities and their web addresses



See also this thread Worldwide device regulatory authorities at country level
 

Edward Reesor

Trusted Information Resource
#8
We prefer the generic language because the details for contacting a specific regulator can change as soon as you carve any details in stone. We had a discussion about this during one audit, where I explained that contact numbers can change frequently and web links can become dead at any time. Even the name of the department can change at the whim of their upper management.

Whereas ours looks a lot like rob73's (above), I do like the approach of Ronen E.'s (above).
 
#9
I have worked in a company where there are separate procedures for Canadian, US and International regulatory submissions. I see regulatory submissions as a form of communication with regulatory authorities. In the case of EU, it's communication with your notified body.
 
Thread starter Similar threads Forum Replies Date
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Naming of SOP doc's - Specific to Calibrations ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
C SOP unification. Revision No, Revision history Document Control Systems, Procedures, Forms and Templates 4
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
M SOP Sample for BC/ISO22301 (Business Continuity) wanted Business Continuity & Resiliency Planning (BCRP) 4
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
V Nature of references allowed to be cited in the SOP US Food and Drug Administration (FDA) 2
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 13
J Just Venting - Do you refer directly to MDR or you just refer to SOP's? CE Marking (Conformité Européene) / CB Scheme 3
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
S Should there be a SOP on Cybersecurity? ISO 14971 - Medical Device Risk Management 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
G NIST SOP 29 - Assignment of Uncertainty - Question General Measurement Device and Calibration Topics 0
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
S SOP Training/Competence in 24/7 Operation contractor company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
J Business Impact Analysis SOP Business Continuity & Resiliency Planning (BCRP) 2
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
A AQL Sampling Plan SOP / WI - Medical Device Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
S Authorized (EC) Representative Contract and SOP EU Medical Device Regulations 12
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
S Post Market Surveillance procedure/ SOP Medical devices Imported Legacy Blogs 0

Similar threads

Top Bottom