posted 23 March 1999 07:18 PM               

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

posted 24 March 1999 10:19 AM               

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

posted 24 March 1999 10:30 AM               

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: kim_dix@hc-sc.gc.ca

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: kmurray@medec.org

Perhaps they may be able to address your specific question. The GHTF site is at http://www.ghtf.org/default.htm . 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 http://www.hc-sc.gc.ca/hpb-dgps/therapeut/ which led me to the International agreements site at http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/intagree.html . 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

posted 25 March 1999 06:36 AM               

That was an interesting topic.Check out the classification rules according to Medical Device Directive at http://europa.eu.int/comm/dg03/directs/dg3d/d2/meddev/md/dirmd/annex9.htm

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

posted 25 March 1999 10:10 AM               

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.

posted 26 March 1999 04:12 PM               

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.

posted 27 March 1999 12:37 AM               

Regards,
Don