1. Marcelo Antunes

    Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018

    Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 -
  2. Marcelo Antunes

    Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations

    Health Canada Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB) Approval Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB)...
  3. K

    Selling products in Canada, distributor? Private Label?

    Hello, The company I work for is not ready to switch over to MDSAP, so we have chosen to forgo our Canadian Licenses since we really haven't sold enough there to justify the additional expense of a MDSAP audit. We have a distributor in Canada that is asking the following: "As your company...
  4. S

    We are planning to sell a Medical Device Group

    We are planning to sell a medical device group, consisting of individually licensed devices (both Class II), made by the same manufacturer. The regulation and guidance explain that we do not need to apply for another licence because the group is deemed licensed if the individual products are...
  5. B

    Our NB doesn't accept new clients for MDSAP

    We are planning to open Canada Market of a company which manufactures class IIa devices. Our problem is that our Notified Body (SGS) is not accepting new clients for MDSAP. What can we do? Is it possible to use another NB only for this qualification?
  6. L

    Classification of Medical vs Wellness Devices

    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...
  7. J

    Health Canada Field Action/Recall MDR Requirements

    Company initiated a recall on some mislabeled product. They are registered in CA but no affected product was distributed in CA. Do I still need to fill out a medical device recall form even though there will be no action taken in CA? Filed an MDR with health CA and stated no product was...
  8. Edward Reesor

    Health Canada to increase PMS requirements

    Yesterday we were notified that Health Canada, in addition to making the MDSAP program mandatory by January 2019, has announced an intent to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada. This appears to be a similar...
  9. J

    ITA (Investigational Testing Authorizations) - Labeling requirements

    Hi all - just hoping to confirm my understanding of the rules for labeling of investigational devices in Canada. The MDR (Section 86) requires the investigational statements to be present in English and French, but doesn't make any statement about where on the packaging these words must...
  10. M

    New Medical Device Accessory with New Function - Is this a major change?

    We'd like to introduce a "fitting kit" disposable accessory that clinicians can use to test out on patients to see if the device is suitable for individual patients. I'm not clear how the addition of such an accessory would affect the regulatory status (510(k) cleared, CE marked, Canadian...
  11. T

    MDSAP readiness - Selling clinical product IVDs into Canada

    Hello and help! My employer is very eager to sell clinical product IVDs into Canada; I am well aware of needing a particular audit outside of our BSI (ISO 13485:2016) spectrum. Anyone have experience with this? Registrars? Links? Standards and thrilling page-turners? I feel like a...
  12. S

    ISO 13485 Cl. 4.2.5 - Requirements for Control of Records

    4.2.5 The organization shall define and implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements. What are some methods that companies use to protect confidential health information in accordance...
  13. S

    MDEL question - Device Establishment Licence

    Hi, A company manufactures and distributes Class I devices in Canada, but it's also manufacturer of a Class II device, for which they hold an MDL. I know MDEL applies to a distributor/importer. But does the fact that the company manufactures Class II and sell devices in Canada make them...
  14. Jane's

    What steps do you take to terminate a product which was licensed for sale in Canada

    This is the requirement from HC site: Did anyone have any first hand experience with discontinuing product which was licensed for sale in Canada. I was wondering specifically if you would obsolete the product technical documentation right away or would you wait the lifetime of the device...
  15. L

    Hearing Aids Labeled as "Used" - Canadian Regulations

    Hi all, It's always awkward to write your first post however I'm really happy I've found this site. What a wealth of information! To those familiar with Canada Medical Device Regulations: Is there a specific requirement (as there is in U.S 21 CFR 801.420 (a) (6) that speaks to "used hearing...
  16. K

    Canada License Amendment - Old Product to New Product

    I am hoping someone can provide me with some assistance as I have tried to find the answer myself and come up empty handed. We currently have a few medical device licenses in Canada and wish to amend one of them to add a new product that is essentially replacing the existing product. There is...
  17. M

    Does MDSAP replace ISO 13485, or do both have to be maintained?

    With just over 17 months until MDSAP is mandatory for Canadian sales, our current ISO 13485 certification body is pressuring us to get on the program. (and I don't blame them...I suspect a flood of requests come 2018, and not enough CB resources to accommodate. :nope: ) Can anyone on the...
  18. amjadrana

    Legal Representation in Canada (Medical Devices)

    I have been asked by a prospective customer, whether I can be a legal representative for them. Can some one tell me whether it is a requirement in Canada? Thank you for your inputs.
  19. L

    Canada Electrical Equipment Marking Language Requirements

    Quick question regarding label marking on our MEE - Are medical devices under the jurisdiction of the inspection department per the Canadian Electrical Code, C22.1-12 rule 2-024? See attached statement. We are trying to determine whether or not we are required to include French on a warning...
  20. S

    What does SOR and DORS stand for in the Medical Devices Regulations?

    In the Medical Devices Regulations (SOR /98-282) or the French version, Règlement sur les instruments médicaux (DORS/98-282), what does SOR and DORS stand for? Thank you!