SOP Template for seeking regulatory clearance - MDSAP

hornet456

Starting to get Involved
#1
Fellow members,

We are undergoing a stage II MDSAP audit for Canada, US and Australia for our class II medical device. The auditor asked for our SOP on how we seek regulatory clearance in these three countries, and how we keep our licenses active.

Given the apparent generic nature of this information, do you have any templates that I could use? Or would the SOP involve outlining the regulatory steps needed to achieve clearance, such as the 510(k) decision flowchart etc?

Any guidance that you can provide on this is greatly appreciated. Thank you for your time.
 
Elsmar Forum Sponsor

hornet456

Starting to get Involved
#3
Hi yodon,

Thanks for your response. It's a finding from our MDSAP stage II audit - the auditor indicates that we need an SOP for communicating with regulatory authorities, both in terms of reporting adverse events as well as other general communication.

Thank you.
 

hornet456

Starting to get Involved
#5
Yodon,

The statement of non-conformity says: "Complaint handling procedure and the notification of adverse events procedure do not the meet US, Canada and Australia requirements for processing customer complaints and notification of adverse events"
 

yodon

Staff member
Super Moderator
#6
That's helpful. The auditor shouldn't be saying you need a Communications SOP (that's consulting) but that you have apparently failed to provide documented procedures for the relevant communications requirements.

In 13485, there is:

8.2.3 Reporting to regulatory authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.


In the US, there's 21 CFR 803 which has:

If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR [medical device reporting] procedures ...

Not sure what the Canadian or Australian requirements are (other than the 13485 reference) but if you don't have procedures addressing these, the finding is legitimate.

I think most companies have some kind of (adverse event) Reporting SOP. (Complaint investigation may determine that the complaint is a reportable event so it generally references the Reporting SOP. From the finding wording, it sounds like you don't have a Complaint Handling procedure - that's another one that most companies have.)

You'll need to look at the specific requirements for each country to determine the extend of your reporting (communications) procedures.
 

hornet456

Starting to get Involved
#7
Yodon,

Thanks for the response and the details, this is very helpful. My mistake earlier, when I said the auditor indicated the need for a communication SOP - it was actually our regulatory affairs manager.

We're planning to lay out a document much like what you recommended, based on per country requirements, at least in the territories that are relevant to our company.
 
Thread starter Similar threads Forum Replies Date
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
C SOP Work Instruction (Job Card) Template Revisions question Document Control Systems, Procedures, Forms and Templates 6
J Ever heard of having a Controlled SOP template? Document Control Systems, Procedures, Forms and Templates 12
S Required Complete calibration SOP, calibration Plan and master list template! IATF 16949 - Automotive Quality Systems Standard 3
L Production and Process Control SOP example or template needed US Food and Drug Administration (FDA) 2
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S SOP Identification of Special Characteristics IATF 16949 - Automotive Quality Systems Standard 6
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M WI vs SOP - Shipping/Receiving Document Control Systems, Procedures, Forms and Templates 3
C Language of SOPs and SOP IDs Document Control Systems, Procedures, Forms and Templates 7
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
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 6
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 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
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 9
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 7
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 14
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

Similar threads

Top Bottom