Classification rules for Canada - Electrosurgical and Cryosurgical Equipment

M
#1
Our company submitted application for device licences with Health Canada for Electrosurgical and Cryosurgical Equipment(Class 2 - Reg.#884.4120 & 878.4350)
CANADA did not accept our product for review as Class 2 and classified devices as Class 3. I was under impression that Canada and USA use harmonized codes...
 
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D

Don Winton

#3
Yea Kevin, I'm here.

This is a new one on me as well. I will look into it and advise further, regardless of what I find.

Regards,
Don
 
M
#4
Don @ Kevin, thanks for your help. I have the standard for Canada. I am not sure, that
they fully know or understand it. What can be other reason for classification of non-invasive deveces as invasive????

I think this is all about money. The base fee for Class 2 application is $200(canadian)
However, for Class 3 in addition to application fee you must pay:
1. Description fee - $140
2. Summary "studies", each component- $1,470
3. Label review - $170
4. If in vitro device - another $470

Total for 1 device review - $2,420

We have 20 different devices in Cryofamily, so if we go thru with this,- it will cost more than $48K for this application!!!!
 
D

Don Winton

#5
Mike,

I could not find the answer to your specific question last night, but this is what I did find.

FDA product codes and classifications can be found at http://www.fda.gov/cdrh/prodcode.html

From that location, I was able to determine that the regulations you quoted are indeed FDA Class II devices:

Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Medical Specialty: Obstetrics/Gynecology
Product Code: HGI
Device Class: 2
Tier: 2
Regulation Number: 884.4120

Device: SYSTEM, CRYOSURGICAL, LIQUID NITROGEN, FOR UROLOGY
Medical Specialty: General & Plastic Surgery
Product Code: FAZ
Device Class: 2
Tier: 2
Regulation Number: 878.4350

Device: UNIT, CRYOSURGICAL, ACCESSORIES
Medical Specialty: General & Plastic Surgery
Product Code: GEH
Device Class: 2
Tier: 2
Regulation Number: 878.4350

After review of the Global Harmonization Task Force (GHTF) members, I found these from Canada:

Mr. Kim Dix
Head, Compliance Unit
Bureau of Compliance and Enforcement
Therapeutic Products Programme
Health Protection Branch
Health Canada
11 Hollard Avenue, Tower "A", 2nd Floor
Hollard Cross, A.L. 3102A2
Ottawa, Ontario K1A 1B9, CANADA
Tele: 613-954-6666
Fax: 613-954-0941
e-mail: [email protected]

Mr. Kevin Murray
Director, Regulatory Affairs and Communications
Medical Devices Canada
401 The West Mall, Suite 510
Etobicoke, Ontario M9C 5J5, CANADA
Tele: 1-416-620-1915
Fax: 1-416-620-1595
e-mail: [email protected]

Perhaps they may be able to address your specific question. The GHTF site: The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices.

Chairmanship of the GHTF is rotated amongst the regulatory representatives of the five Founding Members. The European Commission (EC) is the current Chair.. I was not able to find a document that specifically stated that FDA and Health and Welfare Canada had agreed upon harmonized standards.

I then went to this site *** DEAD LINK REMOVED *** which led me to the International agreements site. There were not any documents there either related to harmonization, but it was getting late and I was tired.

Hope the above information is useful.

Regards,
Don

[This message has been edited by Don Winton (edited 03-24-99).]
 
M

Monica Lewis

#6
Hi Mike,

That was an interesting topic. Check out the EU classification rules according to Medical Device Directive at http://europa.eu.int

I know that this will not help you to get registrated in canada, but the issue about classification is a hot subject.

Regards
Monica
 
M
#7
Hi Don & Monica,

Thank you for your useful information.
In the last two days I left 3 messages to
3 different people with in Health Canada. Hopefully, someone will respond.

In addition, I will try to call members of Global Harmonization Task Force...

I will keep you inform.

Regards,
Mike
 
M
#8
Don, Kevin, Monica

I'm happy to report that after 15 min. of sparring with Dr. Freelan (director of Therapeutic Products Programme, Health Canada), we addressed this issue.

We got Class 2, however, the real news that Canada classification system a little different from FDA and ISO/CE standards.
You must understand the definitions, your product and you need to be able to negotiate.

If someone have any questions, please contact me.

Regards,
Mike
 
D

Don Winton

#9
Congrats on your success. I will keep your offer in mind and do stop in often.

Regards,
Don

[This message has been edited by Don Winton (edited 03-27-99).]
 
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