Classification of Medical vs Wellness Devices

L

LChristos

#1
Hello there,

Thank you for all of the guidance you folks have provided on the forums so far. It has been very informative.

I have been trying to get a handle on classification of digital health devices in Canada.

I have not been able to locate a formal guidance document on the difference between a wellness device vs. a digital health medical device beyond "intended use is a medical purpose" under the F&DA. The line between diagnostic vs monitoring health/wellness is much better demonstrated in UK/FDA/EU guidelines and I am wondering if I can rely on some of that guidance for classifications.

Also I have been searching for examples and guidance on the classification of Class I vs Class II medical device software. I located this notice from Health Canada: Notice - Software Regulated as a Class I or Class II Medical Device (File #: 10-125797-779 - sorry, I can't include links)
however I am unsure if it can still be relied upon for guidance.

Thank you for your time.
 
Elsmar Forum Sponsor
#2
In my experience, the classification heavily leans upon the intended use and labelling of the device in question. I would also refer to the IMDRF SaMD guidance document and the US FDA MDDS guidance as Health Canada supports their classification decisions. If all else fails, the Device Licensing Services Division/Device Classification division can provide classification assistance with the provision of detailed labelling of the device in question for review.
 

RA Guy

Involved In Discussions
#3
Hi LChristos

Be aware that Health Canada is only starting to develop formal guidance and policy on some of these issues. See the slides they presented in May (attached).

Health Canada appears to be aligned with the SAMD work done with the IMDRF.

I agree with liquidimpulse. You need a well defined intended use and follow up with a dialog with Health Canada for their input to your regulatory approach.
 

Attachments

Thread starter Similar threads Forum Replies Date
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
N Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 11
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
N Medical Device Re-Classification EU Medical Device Regulations 2
J Medical Device re-classification and marketing ISO 13485:2016 - Medical Device Quality Management Systems 13
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
M Medical Device News Medical Device Borderline and Classification Manual 1.20 - October 2018 EU Medical Device Regulations 0
H Classification of a Class IIb Medical Device with 3 Components CE Marking (Conformité Européene) / CB Scheme 1
R Vertebroplasty - Medical Device Classification EU Medical Device Regulations 0
C Substance based Medical Device Classification under MDR - Rule 21 EU Medical Device Regulations 9
rob73 EU Medical Device Classification Spreadsheet EU Medical Device Regulations 2
S Medical Device Classification - Laser Guided Positioner EU Medical Device Regulations 2
W Determining Medical Device Classification in Mexico Other Medical Device Regulations World-Wide 5
shimonv EU classification for a Medical Device Accessory EU Medical Device Regulations 16
J0anne MDD 93/42/EEC Medical Device Classification EU Medical Device Regulations 3
B CE Classification of a Medical Device CE Marking (Conformité Européene) / CB Scheme 17
K Classification of the Reseller of Stand Alone Medical Device Software ISO 13485:2016 - Medical Device Quality Management Systems 3
T CE Marking Medical Device and classification CE Marking (Conformité Européene) / CB Scheme 6
E Japan - Medical Device Classification for Mass Spectrometry Japan Medical Device Regulations 2
A Classification of Medical Device Accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
T What is Medical Device Classification for diagnostic equipment in ASEAN ? Other Medical Device Regulations World-Wide 2
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
S Please explain Medical Device Product Classification Rationale 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Z Kyrgyzstan Medical Device Classification and Registration Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
B KOREA MFDS (KFDA) Medical Device Classification Rules Other Medical Device Regulations World-Wide 3
K Medical Application Classification in Controlled/Uncontrolled by Mobile App State. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Software Medical Device Classification Medical Information Technology, Medical Software and Health Informatics 8
P Classification of Medical Device with Sub Code Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur Guidance Document - Medical Device Classification Product Codes Other US Medical Device Regulations 1
A Japan - Medical Device Classification for Autoclave Tape Japan Medical Device Regulations 6
D Keeping Same Medical Device Name but Changing Classification Medical Information Technology, Medical Software and Health Informatics 3
T X-Ray Template Medical Device Classification (US) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M United Arab Emirates Classification Rules for Medical Devices Other Medical Device Regulations World-Wide 2
A Classification of Medical Device with Partial Compliance with a particular standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Classification of Medical Devices and Medical "Furniture" EU Medical Device Regulations 2
R FDA Rules on Medical Device Classification Listings? Other US Medical Device Regulations 3
Z Medical Device Classification of a Needle Holder EU Medical Device Regulations 9
R Classification of Actuators for MDIs in Class 1 Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 9
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
Y FDA Classification for Medical Device Power Adaptors (Power Supplies) Other US Medical Device Regulations 12
D 510(k) Medical Device Classification and Regulatory Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Need some brainstorming on the Classification of a Medical Device CE Marking (Conformité Européene) / CB Scheme 8

Similar threads

Top Bottom