Inquiry for Class II medical device licence amendment application

B

bennylee

#1
Hi All,

Our company would like to add one model (same intended for use) in the existing "group family class II medical device licence", we planed to use "Licence Amendment Application form" to apply,
When fillin the form, we are not very clear about the application process for some item as the following part:

Question (1)
For Item 7: ATTESTATIONS about
  • Attestation of Safety and Effectiveness Requirements
  • Attestation of Labelling Requirements
Do we need to submit any evidence document during application?

Question (2)
Item 13: LIST OF RECOGNIZED STANDARDS COMPLIED WITH IN THE
MANUFACTURE OF THE DEVICE
  • Actually, products are designed based on the following standard
    1. IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-1-6:2010
    2. ISO 10993-5:2009 ISO 10993-10:2010 ISO 14155:2011
    3. ISO 14971:2007 IEC 62304:2006
  • But for 3rd party test report, we only have IEC 60601-1:2005 IEC 60601-1-2:2007 (for other standard, we use self-declaration with internal test), is it better we only mention IEC 60601-1:2005 IEC 60601-1-2:2007?

Thanks,
Benny
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
Re: Inquiry for licence amendment application

For class II devices there is no need to submit additional documents. You just need to sign the attestation. Just list the standards that apply. There is a list that you can find at the health Canada site with the list of acceptable standards for health Canada.
 
Thread starter Similar threads Forum Replies Date
B Partial Joint (Hip Prosthesis) Replacement Class inquiry EU Medical Device Regulations 3
I Food Contact Materials Declaration of Compliance Inquiry - (EC) 1935/2004 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
D Inquiry about QC Testing (In Line Sampling) Reliability Analysis - Predictions, Testing and Standards 13
R Customer Complaint/Nonconforming Product Inquiry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
B Inquiry about Canadian Medical Device Licence with different Establishment Other Medical Device Related Standards 1
B Inquiry about IEC 60601-2-10:2012 & IEC 60601-1-11:2010 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N NIST Special Publications and Technical Notes inquiry General Measurement Device and Calibration Topics 4
S Site Master File inquiry - Distribution in India EU Medical Device Regulations 6
R Six Sigma / DPMO Related Inquiry - A 6 Sigma related Statistical Sampling question Six Sigma 2
L Customer Inquiry - Graph showing the expansion of oil (mm) at different temperatures Service Industry Specific Topics 5
R Inquiry for License needed when not releasing your self? Pharmaceutical Products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Kales Veggie Shop Floor Real Time SPC Inquiry Statistical Analysis Tools, Techniques and SPC 15
T Inquiry about the number of changes in a document Document Control Systems, Procedures, Forms and Templates 7
K Inquiry on kinds of document a customer is requiring us to submit? Quality Tools, Improvement and Analysis 2
Marc FDA begins inquiry on Guidant defibrillator flaw World News 1
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 5
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
R Class 1 Convenience kits for home teeth impression, NOT smile direct or other for alignment purposes Canada Medical Device Regulations 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
D Adding a Class I to a sample box Canada Medical Device Regulations 5
T Class A PRTD beyond 300°C General Measurement Device and Calibration Topics 0
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Protective earth for Class I ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A AQL - How to count samples with defects for each defect class AQL - Acceptable Quality Level 17
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12

Similar threads

Top Bottom