Regulatory Open Forum

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Hello Emi,

Typically the requirements for country of origin in labelling is more specific to national requirements and not necessarily specific to medical devices.  You will not find something like this requirement in Section 801 of the regulations.  This is not regulated too strongly so there is no consistency in applying this, but there are other industries where this is more common, i.e. clothing.  Where you are placing the medical device in the market really should determine the country requirements as they can vary.  Most companies usually include this on labelling as part of trade commission requirements.

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear Richard, 

Thank you very much for your feedback. I can now recommend a new project team to re-design including the country of origin to avoid unforeseen trade customs issues, and to keep consistency with our other product labels based on the labelling SOP.

Thank you again and have a great weekend!

Hello Emi,

Typically the requirements for country of origin in labelling is more specific to national requirements and not necessarily specific to medical devices.  You will not find something like this requirement in Section 801 of the regulations.  This is not regulated too strongly so there is no consistency in applying this, but there are other industries where this is more common, i.e. clothing.  Where you are placing the medical device in the market really should determine the country requirements as they can vary.  Most companies usually include this on labelling as part of trade commission requirements.

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear all,

I have a question how do you decide "made in XX"?

If original manufacturer was in many different countries, however you made final inspection in US. Should it be made in US?

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear Antonio

No, the final inspection does not count as country of origin. Here are two guidance documents that explain the rules around substantial transformation, assembly, tarriff shift, etc.

https://www.cbp.gov/trade/rulings/informed-compliance-publications/marking-country-origin-us-imports

https://www.ftc.gov/business-guidance/resources/complying-made-usa-standard

Dear all,

I have a question how do you decide "made in XX"?

If original manufacturer was in many different countries, however you made final inspection in US. Should it be made in US?

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

In the USA, I believe the requirement for country of origin statement is in 19USC134.

https://www.ecfr.gov/current/title-19/chapter-I/part-134

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>

Dear All, <o:p></o:p>

Thank you all for your valuable input and follow-up!  I learned new things and was able to be more confident!<o:p></o:p>

Thank you again and have a great week!<o:p></o:p>

Kind regards,<o:p></o:p>

In the USA, I believe the requirement for country of origin statement is in 19USC134.

https://www.ecfr.gov/current/title-19/chapter-I/part-134

Dear Communities, <o:p></o:p>

Do medical device labels require country of origin marking? <o:p></o:p>

Our products are marketed globally. Current labels include ""Made in xxx"".  We are redesigning a label for a new product, and are considering omitting the country of origin due to the space constraints.<o:p></o:p>

As far as I know, there is no such requirement in the USA (21CRF801.1: Manufacturer's name and address). However, I am not aware of other regulations or rules requirements such as commercial goods for trade (export/import).  <o:p></o:p>

Again, is it mandatory to print "Made in xxx" on the product label for the global area? I think it is safe to keep the country of origin marking, but should I insist on keeping it as before? <o:p></o:p>

Any input or feedback is welcome !<o:p></o:p>

Thanks.<o:p></o:p>