How is "Made in USA" act applicable to Medical Devices

somashekar

Staff member
Super Moderator
#1
If a medical device manufactured outside the USA and supplied to the USA customer (manufacturer) prior to sterilization, can the USA manufacturer label the device as "Made in USA" after sterilization and place it in the USA market / Export from USA ?
Further, if the USA Government is to buy the medical device from an USA company, must the device necessarily be "Made in USA" labelled ?
 
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A

Adele

#3
I am not sure if the "Made in USA" is mentioned on label ?

A medical device that is manufactured outside of the USA is required to have the country of origin conspicuously, legibly, indelibly and permanently
marked on the device or labelling. This can be found in 19 CFR 134 and §304 Tariff Act of 1930.

Somashekar - I am not 100% sure of the answer so the response is my opinion only and I don't have a regulation to support it. I don't believe that the sterilisation step is sufficient enough to declare "Made in the USA". If you sell a device that is to be sterilised by the user prior to use, that wouldn't influence the country of manufacture.
 

bio_subbu

Super Moderator
#4
Dear Mr. Somashekar

The country of origin regulations administered by the US Customs and Border Protection (CBP). The CBP allows foreign made devices to be labeled "Made in the USA" if they contain a certain percentage of US made parts. If the device is made elsewhere and is sterilized in the U.S, it should not be labeled “Made in the USA ” because that is misleading.

I would request you to please check with “US Customs and Border Protection” directly..

Regards
S.Subramaniam
 
R

ramkannan13

#5
I have got another question regarding the " MADE In ____" Statement, say if its not made in the USA but will be sold in their market , then is it imperative to have the MADE IN " so & So " Country needed ? and also please advise the list of Countries where they are particular about the " MADE in " Logo in labelling.

P.S: This Medical device does not require any Sterilization.


You're respone is much appreciated! Thank you.

:thanx:Rk
 
R

ramkannan13

#6
A medical device that is manufactured outside of the USA is required to have the country of origin conspicuously, legibly, indelibly and permanently
marked on the device or labelling. This can be found in 19 CFR 134 and §304 Tariff Act of 1930.


Adele,

I tried searching in the FDA website for 19 CFR 134 , can you kindly help me find the hyperlink for the same.

Many Thanks,
Rk
 
R

ramkannan13

#7
A medical device that is manufactured outside of the USA is required to have the country of origin conspicuously, legibly, indelibly and permanently
marked on the device or labelling. This can be found in 19 CFR 134 and §304 Tariff Act of 1930.


Adele,

I tried searching in the FDA website for 19 CFR 134 , can you kindly help me find the hyperlink for the same.

Many Thanks,
Rk
Hi Adele,

After few minutes of google and reading the previous thread in the forum found that , the Made In logo is not particularly related with the Medical Regulation its more about the Countries Commerical Customs Regulation with that piece of info I was able to find the link for 19 CFR 314

http://ecfr.gpoaccess.gov/cgi/t/tex...e=19:1.0.1.1.28&idno=19#19:1.0.1.1.28.2.257.1

Thanks!
 
M

MIREGMGR

#8
US FDA uses two different country of origin statuses.

Labels on devices that cross the US border are expected by FDA to conform to Department of Commerce rules, which are commonly known as the Customs and Border Protection (CBP) Country of Origin requirement. In general, these rules define the Country of Origin as the location of last "substantial transformation". Physical fabrication steps are a substantial transformation. Sterilization is a substantial transformation. Packaging and labeling may or may not be, depending on circumstances. CBP has an extensive set of rules and precedents, and formal procedures for obtaining a judgement as to a product's status.

More recently, FDA began to use the PREDICT system for evaluation of import shipment documentation. PREDICT shipment documentation is expected by FDA to include not the CBP Country of Origin, but instead the FDA Country of Origin, which is defined as the location at which the product legally becomes an FDA Listed medical device.

When a product is made by an offshore fabricator and that company is a 21CFR 807.65(a) component maker rather than a 21CFR 820 device maker, and that offshore company is not Registered, does not List its products as devices, and does not distribute those products to end users, and the initial importer of those products is Registered and Lists those products as devices, then those products legally become medical devices at the US initial importer and that location determines the FDA Country of Origin for PREDICT purposes.

The FDA Country of Origin for PREDICT purposes is not required to be stated on the label, and probably should not be unless the CBP Country of Origin is clearly identified so that no confusion results at time of border inspection.
 
A

Adele

#9
Hi Adele,

After few minutes of google and reading the previous thread in the forum found that , the Made In logo is not particularly related with the Medical Regulation its more about the Countries Commerical Customs Regulation with that piece of info I was able to find the link for 19 CFR 314

http://ecfr.gpoaccess.gov/cgi/t/tex...e=19:1.0.1.1.28&idno=19#19:1.0.1.1.28.2.257.1

Thanks!
It is important to realise that market access is not the sole domain of the regulatory body and other bodies all involved and they also have regulations that you must comply with.

As MIREGMGR has also explained, sometimes there is a conflict between these set of regulations.

Another reason for labelling the product with the Country of Origin is Free-Trade Agreements and duty that is applicable to your device on importation.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#10
When a product is made by an offshore fabricator and that company is a 21CFR 807.65(a) component maker rather than a 21CFR 820 device maker, and that offshore company is not Registered, does not List its products as devices, and does not distribute those products to end users, and the initial importer of those products is Registered and Lists those products as devices...
I don't quite understand how that is possible. If a product is not a medical device, but only a raw material or component to be used in the manufacture or assembly of one (807.65(a)), and therefore its offshore fabricator is exempt from registration and listing, how can / why should the initial importer list them without performing further manufacturing steps (which would make them more than just an "initial importer")?

Relating to the OP - do you consider an unsterilised finished medical device "a component to be used in the manufacture of a medical device" with such manufacture consisting of merely sterilising it?

I tend to think that finished medical devices that are imported non-sterile for consequent sterilisation would be considered medical devices requiring registration and listing, because it's not always possible to readily distinguish between sterile and non-sterile versions of such devices.
 
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