Regulatory Open Forum

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

Russia requests "made in XXXX" on product labels
-------------------------------------------
Ondina Maria Iovicin - Grigorescu
Stryker
Montreux
Switzerland
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

Not required for EU nor Australia as far as I am aware.

-------------------------------------------
Sandra Nicoll
European Veterinary Regulatory & Technical Services Manager
Abbott - ENTERPRISE
Maidenhead, Berkshire
United Kingdom
-------------------------------------------


Original Message:
Sent: 10-15-2014 05:31
From: Ondina Maria Iovicin - Grigorescu
Subject: Country Of Origin


Russia requests "made in XXXX" on product labels
-------------------------------------------
Ondina Maria Iovicin - Grigorescu
Stryker
Montreux
Switzerland
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

COO is generally a Fair Trade regulatory requirement, not explicit in medical device regulatory requirements.

Certainly a requirement in industries such as toys to electronics to textiles and household goods. Since it is the basis of so many other activities, I advocate marking COO on packaging of all devices for international trade. 

I do know that in those other industries in the US, if a device is made in the US, you do not need to include COO (Made in the USA) It is not required.

If you are looking for regulations, look in commerce rules.

-------------------------------------------
Thomas Heckmann
Regulatory Manager
Reichert Inc
Depew NY
United States
-------------------------------------------


Original Message:
Sent: 10-16-2014 04:39
From: Sandra Nicoll
Subject: Country Of Origin


Not required for EU nor Australia as far as I am aware.

-------------------------------------------
Sandra Nicoll
European Veterinary Regulatory & Technical Services Manager
Abbott - ENTERPRISE
Maidenhead, Berkshire
United Kingdom
-------------------------------------------


Original Message:
Sent: 10-15-2014 05:31
From: Ondina Maria Iovicin - Grigorescu
Subject: Country Of Origin


Russia requests "made in XXXX" on product labels
-------------------------------------------
Ondina Maria Iovicin - Grigorescu
Stryker
Montreux
Switzerland
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

My experience is the same as what Thomas described. Look in the country's import/export regulations. They will give you labeling and documentation requirments for COO and other special requirements in order to import/export products. I have run into COO requirments for most countries when exporting an IVD product from the US. I have even had product thrown away in Singapore customs as it did not have the correct documentaion. Stephanie ------------------------------------------- Stephanie Gaulding Principal Consultant CAI Consulting Centreville VA United States -------------------------------------------
Original Message: Sent: 10-16-2014 09:52 From: Thomas Heckmann Subject: Country Of Origin COO is generally a Fair Trade regulatory requirement, not explicit in medical device regulatory requirements. Certainly a requirement in industries such as toys to electronics to textiles and household goods. Since it is the basis of so many other activities, I advocate marking COO on packaging of all devices for international trade. I do know that in those other industries in the US, if a device is made in the US, you do not need to include COO (Made in the USA) It is not required. If you are looking for regulations, look in commerce rules. ------------------------------------------- Thomas Heckmann Regulatory Manager Reichert Inc Depew NY United States -------------------------------------------
Original Message: Sent: 10-16-2014 04:39 From: Sandra Nicoll Subject: Country Of Origin Not required for EU nor Australia as far as I am aware. ------------------------------------------- Sandra Nicoll European Veterinary Regulatory & Technical Services Manager Abbott - ENTERPRISE Maidenhead, Berkshire United Kingdom -------------------------------------------
Original Message: Sent: 10-15-2014 05:31 From: Ondina Maria Iovicin - Grigorescu Subject: Country Of Origin Russia requests "made in XXXX" on product labels ------------------------------------------- Ondina Maria Iovicin - Grigorescu Stryker Montreux Switzerland -------------------------------------------
Original Message: Sent: 10-14-2014 09:18 From: Steven Goldberg Subject: Country Of Origin All, I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require. Any advice would be appreciated. Thanks in advance, Steven ------------------------------------------- Steven Goldberg RAC, MBA, PMP Regulatory Affairs Manager Nova Biomedical Waltham, MA United States -------------------------------------------

US customs regulations require COO marking for all devices made outside and to be imported into U.S. Please refer to 19 CFR 134.11.


-------------------------------------------
Jintao Chen PhD
Director, Regulatory Affairs
Roche Molecular Systems
Pleasanton CA
United States
-------------------------------------------


Original Message:
Sent: 10-16-2014 10:20
From: Stephanie Gaulding
Subject: Country Of Origin

My experience is the same as what Thomas described. Look in the country's import/export regulations. They will give you labeling and documentation requirments for COO and other special requirements in order to import/export products. I have run into COO requirments for most countries when exporting an IVD product from the US. I have even had product thrown away in Singapore customs as it did not have the correct documentaion.


Stephanie

-------------------------------------------
Stephanie Gaulding
Principal Consultant
CAI Consulting
Centreville VA
United States
-------------------------------------------

Thank you both,

To add to this question, when determining country of origin, what are the deciding factors?  Is the definition of country of origin standardized across various commercial fields (i.e. Textile, Medical, Electronics, etc.)?  

Thanks,

Tom  

-------------------------------------------
Thomas Ostrowski
Regulatory Affairs Specialist
Draeger Medical Systems Inc.
Andover MA
United States
-------------------------------------------


Original Message:
Sent: 10-15-2014 05:31
From: Ondina Maria Iovicin - Grigorescu
Subject: Country Of Origin


Russia requests "made in XXXX" on product labels
-------------------------------------------
Ondina Maria Iovicin - Grigorescu
Stryker
Montreux
Switzerland
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

Hi Thomas,
This question gets tricky as the CoO determination can be influenced both by where you are manufacturing and where you are shipping.  The USA has very specific requirements around claiming Made in the USA on your label (see FTC restrictions), as does Switzerland.  The USA also has very specific requirements around determining the country of origin when all activities are not in one location, or all components do not come from a single location.  This leads to what is referred to as determining the point of substantial transformation, which can be influenced by previous legal determinations.  Other countries may determine CoO based upon value of individual components or operations, or upon the entity that takes responsibility for the release of the product. 

If your product is manufactured and sourced from a single location, then it should be straightforward. Please reply to me directly if you have further questions.

Carole
-------------------------------------------
Carole Harris RAC
International Regulatory Consultant
Asuragen, Inc
Austin TX
United States
-------------------------------------------


Original Message:
Sent: 10-16-2014 11:44
From: Thomas Ostrowski
Subject: Country Of Origin

Thank you both,

To add to this question, when determining country of origin, what are the deciding factors?  Is the definition of country of origin standardized across various commercial fields (i.e. Textile, Medical, Electronics, etc.)?  

Thanks,

Tom  

-------------------------------------------
Thomas Ostrowski
Regulatory Affairs Specialist
Draeger Medical Systems Inc.
Andover MA
United States
-------------------------------------------


Original Message:
Sent: 10-15-2014 05:31
From: Ondina Maria Iovicin - Grigorescu
Subject: Country Of Origin


Russia requests "made in XXXX" on product labels
-------------------------------------------
Ondina Maria Iovicin - Grigorescu
Stryker
Montreux
Switzerland
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

I haven't worked with Saudi Arabia the last couple of years but as far as I remember they also require COO marking for medical devices.

-------------------------------------------
Patricia Taige
Director Quality Assurance & Regulatory Affairs
Seno Medical Instruments Inc.
San Antonio TX
United States
-------------------------------------------

Hi Steven

In Brazil ANVISA recognizes the concept of legal manufacturer. So, it is not necessary to include MADE IN statement under RA point of view.
However, the customs requires the origin information for taxes purposes. As the origin is not always clear in the registrations, it is highly recommended to include this information on the labels.

Let me know if you have any comment,

Regards

-------------------------------------------
ANDRE JOCHEN RAC
SAO PAULO
Brazil
-------------------------------------------


Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------

We need to look at the applicable requirements from different angles (e.g., Customs and Health Authority/FDA labeling requirements per se).

As for import purposes and in the US, as an example, COO is regulated under the Tariff Act of 1930 (Chapter 4 of USC, Title 19; that is, 19 USC 4).

You may download the applicable Act in PDF at http://www.regulatorydoctor.com/19-usc-4-tariff-act-of-1930/

 ____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Original Message:
Sent: 10-14-2014 09:18
From: Steven Goldberg
Subject: Country Of Origin

All,
I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
Any advice would be appreciated.
Thanks in advance,
Steven

-------------------------------------------
Steven Goldberg RAC, MBA, PMP
Regulatory Affairs Manager
Nova Biomedical
Waltham, MA
United States
-------------------------------------------