Reclassification of a Medical Device by Health Canada

Sheemah

Starting to get Involved
#1
Hi Everyone,

What could be the possible ramifications if Health Canada chooses to reclassify your device from Class-I to Class-II?
We already have an Quality Management system in place and are ISO 13485 certified.

It would be great if someone has experience with reclassification of devices in Health Canada.

Thanks for help in advance.

Sheemah:D
 
Elsmar Forum Sponsor

Sheemah

Starting to get Involved
#3
Re: Reclassification of Device by Health Canada

Hi Sidney,

Thank for the reply, but the reclassification discussed in this thread is inregards to FDA and not Health Canada.
I am not able to find any thing about what could be the possible outcome ,if Health Canada chooses to reclassify your device from Class-I to Class-II & what could be the possible ramifications of that?

Thanks,
Sheemah
 

DannyK

Trusted Information Resource
#4
If Health Canada reclassified the medical device from class I to class II, the requirement for getting a class II license applies. This means that you have to get your quality system certified to ISO 13485:2003 + CMDCAS requirements.
 

mihzago

Trusted Information Resource
#5
I just went through that exact process.
If you already have the ISO 13485 cert (make sure you have the CMDCAS designation, or MDSAP), then you should only have to submit a New Class 2 Medical Device Application.
 
Thread starter Similar threads Forum Replies Date
K Class III Medical Device Reclassification Other Medical Device and Orthopedic Related Topics 3
D FDA Reclassification of Medical Devices - Class III device down to Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Reclassification of Electroconvulsive Therapy Devices Medical Device and FDA Regulations and Standards News 0
B Reclassification of Spinal Implants via Rule 8 (EU 2017/745) EU Medical Device Regulations 0
Ronen E Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin Other US Medical Device Regulations 1
S Federal Register - Software Reclassification (MDDS) - Final Decision by FDA yet? Other US Medical Device Regulations 3
A Combination Product - Legacy Drugs and Reclassification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J 2005/50/EEC Reclassification ISO 13485:2016 - Medical Device Quality Management Systems 4
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
J Medical software Patient outcome Medical Information Technology, Medical Software and Health Informatics 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 Other Medical Device Regulations World-Wide 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
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3

Similar threads

Top Bottom