Regulatory Open Forum

When you said, "Could we use both names in English and English for all our documentation?", I'm wondering if you instead meant "Could we use both names in English and French for all our documentation?"  Are you able to clarify?

Also of note:  The answer(s) to the question will generally be dependent on the jurisdiction in which the subject device is to be marketed.  Therefore in due course we may need to expand the scope of the discussion beyond the following Canadian-centric response.

For Canadian marketing, and presuming the subject device is not a combination product, then here are a couple points for consideration:

1. Canadian Medical Devices Regulations (CMDR) Subsections 23(1) and 23(3) with their French and/or English language requirements for manufacturer name therein pertain to the device label (including the instructions for use) rather than "all documentation".  Therefore, with respect to the device label, be sure you're language practices comply with CMDR Subsections 23(1) and 23(3).

2. Regarding general ISO 13485 Quality Management System (QMS) documentation (e.g., clause 4.2.1 documentation), such documentation generally needs to be in a language accepted by the ISO Registrar.  So if the company name could reasonably impact the accurate/effective interpretation of such documentation, then the company name would need to be in the specified / agreed upon language.  Beyond these factors, the company name in the QMS documentation would generally need to match that which is recorded in the formal contractual agreement and account documents established with the Registrar, which is where the legal implications of the name could arise (note that this response is not intended to be legal counsel).

As noted above, the target marketing jurisdiction needs to be known in order to fully explore the topic.  For example, certain device-specific QMS documents like the Medical Device File may need to be in the language of the presiding regulatory authority who reviews the device marketing application.

When you said, "Could we use both names in English and English for all our documentation?", I'm wondering if you instead meant "Could we use both names in English and French for all our documentation?"  Are you able to clarify?

Also of note:  The answer(s) to the question will generally be dependent on the jurisdiction in which the subject device is to be marketed.  Therefore in due course we may need to expand the scope of the discussion beyond the following Canadian-centric response.

For Canadian marketing, and presuming the subject device is not a combination product, then here are a couple points for consideration:

1. Canadian Medical Devices Regulations (CMDR) Subsections 23(1) and 23(3) with their French and/or English language requirements for manufacturer name therein pertain to the device label (including the instructions for use) rather than "all documentation".  Therefore, with respect to the device label, be sure you're language practices comply with CMDR Subsections 23(1) and 23(3).

2. Regarding general ISO 13485 Quality Management System (QMS) documentation (e.g., clause 4.2.1 documentation), such documentation generally needs to be in a language accepted by the ISO Registrar.  So if the company name could reasonably impact the accurate/effective interpretation of such documentation, then the company name would need to be in the specified / agreed upon language.  Beyond these factors, the company name in the QMS documentation would generally need to match that which is recorded in the formal contractual agreement and account documents established with the Registrar, which is where the legal implications of the name could arise (note that this response is not intended to be legal counsel).

As noted above, the target marketing jurisdiction needs to be known in order to fully explore the topic.  For example, certain device-specific QMS documents like the Medical Device File may need to be in the language of the presiding regulatory authority who reviews the device marketing application.

When you said, "Could we use both names in English and English for all our documentation?", I'm wondering if you instead meant "Could we use both names in English and French for all our documentation?"  Are you able to clarify?

Also of note:  The answer(s) to the question will generally be dependent on the jurisdiction in which the subject device is to be marketed.  Therefore in due course we may need to expand the scope of the discussion beyond the following Canadian-centric response.

For Canadian marketing, and presuming the subject device is not a combination product, then here are a couple points for consideration:

1. Canadian Medical Devices Regulations (CMDR) Subsections 23(1) and 23(3) with their French and/or English language requirements for manufacturer name therein pertain to the device label (including the instructions for use) rather than "all documentation".  Therefore, with respect to the device label, be sure you're language practices comply with CMDR Subsections 23(1) and 23(3).

2. Regarding general ISO 13485 Quality Management System (QMS) documentation (e.g., clause 4.2.1 documentation), such documentation generally needs to be in a language accepted by the ISO Registrar.  So if the company name could reasonably impact the accurate/effective interpretation of such documentation, then the company name would need to be in the specified / agreed upon language.  Beyond these factors, the company name in the QMS documentation would generally need to match that which is recorded in the formal contractual agreement and account documents established with the Registrar, which is where the legal implications of the name could arise (note that this response is not intended to be legal counsel).

As noted above, the target marketing jurisdiction needs to be known in order to fully explore the topic.  For example, certain device-specific QMS documents like the Medical Device File may need to be in the language of the presiding regulatory authority who reviews the device marketing application.

When you said, "Could we use both names in English and English for all our documentation?", I'm wondering if you instead meant "Could we use both names in English and French for all our documentation?"  Are you able to clarify?

Also of note:  The answer(s) to the question will generally be dependent on the jurisdiction in which the subject device is to be marketed.  Therefore in due course we may need to expand the scope of the discussion beyond the following Canadian-centric response.

For Canadian marketing, and presuming the subject device is not a combination product, then here are a couple points for consideration:

1. Canadian Medical Devices Regulations (CMDR) Subsections 23(1) and 23(3) with their French and/or English language requirements for manufacturer name therein pertain to the device label (including the instructions for use) rather than "all documentation".  Therefore, with respect to the device label, be sure you're language practices comply with CMDR Subsections 23(1) and 23(3).

2. Regarding general ISO 13485 Quality Management System (QMS) documentation (e.g., clause 4.2.1 documentation), such documentation generally needs to be in a language accepted by the ISO Registrar.  So if the company name could reasonably impact the accurate/effective interpretation of such documentation, then the company name would need to be in the specified / agreed upon language.  Beyond these factors, the company name in the QMS documentation would generally need to match that which is recorded in the formal contractual agreement and account documents established with the Registrar, which is where the legal implications of the name could arise (note that this response is not intended to be legal counsel).

As noted above, the target marketing jurisdiction needs to be known in order to fully explore the topic.  For example, certain device-specific QMS documents like the Medical Device File may need to be in the language of the presiding regulatory authority who reviews the device marketing application.

When you said, "Could we use both names in English and English for all our documentation?", I'm wondering if you instead meant "Could we use both names in English and French for all our documentation?"  Are you able to clarify?

Also of note:  The answer(s) to the question will generally be dependent on the jurisdiction in which the subject device is to be marketed.  Therefore in due course we may need to expand the scope of the discussion beyond the following Canadian-centric response.

For Canadian marketing, and presuming the subject device is not a combination product, then here are a couple points for consideration:

1. Canadian Medical Devices Regulations (CMDR) Subsections 23(1) and 23(3) with their French and/or English language requirements for manufacturer name therein pertain to the device label (including the instructions for use) rather than "all documentation".  Therefore, with respect to the device label, be sure you're language practices comply with CMDR Subsections 23(1) and 23(3).

2. Regarding general ISO 13485 Quality Management System (QMS) documentation (e.g., clause 4.2.1 documentation), such documentation generally needs to be in a language accepted by the ISO Registrar.  So if the company name could reasonably impact the accurate/effective interpretation of such documentation, then the company name would need to be in the specified / agreed upon language.  Beyond these factors, the company name in the QMS documentation would generally need to match that which is recorded in the formal contractual agreement and account documents established with the Registrar, which is where the legal implications of the name could arise (note that this response is not intended to be legal counsel).

As noted above, the target marketing jurisdiction needs to be known in order to fully explore the topic.  For example, certain device-specific QMS documents like the Medical Device File may need to be in the language of the presiding regulatory authority who reviews the device marketing application.