Importing exempt Class I device from non-registered manufacturer

L

LloydC

#1
Hello,

I am attempting to import suction cupping sets for use in massage and alternative therapy treatments. From my understanding, this is a Class I medical device. I searched the FDA database and other companies have similar things listed under regulation 890.5765 "Pressure-applying device".
I buy a Chinese brand from a distributor in California, but would like to buy from the manufacturer. The manufacturer says they do not have FDA registration and had no problems selling to US customers.
I'm not sure about this and want to import it correctly without any problems. The California supplier is listed under the FDA as a specification developer for this regulation number.

Whats the best way about importing this item if the manufacturer won't register and list their products? As a initial importer, I think I have to import from registered manufacturers. If I became a specification developer, could I import from non registered manufacturers? I rather not have to pay the FDA fee if at all possible.

Thanks in advance.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I buy a Chinese brand from a distributor in California, but would like to buy from the manufacturer. The manufacturer says they do not have FDA registration and had no problems selling to US customers.
I'm not sure about this and want to import it correctly without any problems. The California supplier is listed under the FDA as a specification developer for this regulation number.

Whats the best way about importing this item if the manufacturer won't register and list their products? As a initial importer, I think I have to import from registered manufacturers. If I became a specification developer, could I import from non registered manufacturers? I rather not have to pay the FDA fee if at all possible.
Every medical device marketed in the US must be the legal responsibility of a particular company, as indicated by that company having registered with the FDA and listed that device at the FDA DRLM site. Since the product is made by a non-registered company, it is not a medical device when they sell it. Thus if you bring it into the US, it must be on the basis that you are importing a non-medical-device object and making it into a medical device. You can do this as a Specification Developer or a Manufacturer...there is no practical difference in this context, as you have 100% responsibility for the device in any case. You will be responsible for the maker's quality control, biocompatibility, etc., in regard to the units they sell you.

There is no legal way to do what you seek to do without registering and listing with the FDA.

Aside from the ethical and legal constraints, the California supplier would have both motivation and knowledge to observe your actions in the marketplace and "drop a dime on you" with FDA if you were marketing a product as a device without registering and listing.
 

bio_subbu

Super Moderator
#3
To import a medical device both the U.S. initial distributor/importer and the foreign manufacturer have to register with the FDA. An initial distributor/importer is only required to register with the FDA. A foreign manufacturer must register their establishment with the FDA, list their devices, and pay the establishment registration fee. If you were to become a specification developer, you would have to register, list, and pay the fee. If you use a foreign contract manufacturer, the foreign contract manufacturer is also required to register, list and pay the fee.

Please refer below link on “Who Must Register, List and Pay the Fee”

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

As regards to registration instructions refer below FDA links

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053185.htm.

http://www.fda.gov/MedicalDevices/D...YourDevice/RegistrationandListing/default.htm

Hope you will find useful and relevant.

Regards
S. Subramaniam
 
Thread starter Similar threads Forum Replies Date
D Importing a general wellness low risk product Other US Medical Device Regulations 3
I Importing prototype without CE (dos and don'ts ) EU Medical Device Regulations 9
S Importing Medical devices class I in EU Other Medical Device and Orthopedic Related Topics 5
O Importing a Medical Device from abroad 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Importing a Registered Class II Device, the Applying Our Label - Need New 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F Mexico Medical Device Importing and Servicing Other Medical Device Regulations World-Wide 2
ScottK Importing medical device for use in fit testing of packaging Other US Medical Device Regulations 3
M Importing medical devices to EU, Germany EU Medical Device Regulations 6
M Importing a Demo Medical Device into the US US Food and Drug Administration (FDA) 3
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
JanWarner Importing a Finished Medical Device from China (tooth whitener w/ peroxide) China Medical Device Regulations 2
O Importing Data via Script - Assign Column as Text (Minitab) Using Minitab Software 3
W What Information is provided when Importing Products into USA US Food and Drug Administration (FDA) 1
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
S Importing a DC motor to UK that is less than 50VDC CE Marking (Conformité Européene) / CB Scheme 11
P Requirements for Importing Hydrocolloid Bandages into the US from China Other US Medical Device Regulations 2
Q FDA Registration and Importing Medical Device Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
N Importing Diagnostic kit from US, UK Other Medical Device Regulations World-Wide 5
B Class I Medical Device Importing for OEM Requirements EU Medical Device Regulations 3
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
M Importing Material before the 510(k) is Approved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Importing CE marked Syringes Into the US Other US Medical Device Regulations 2
I Importing Medical Devices into the USA from Germany (Drop Shipments) US Food and Drug Administration (FDA) 2
D Importing Class II Male Latex Condoms From China to US Other US Medical Device Regulations 2
R Importing Breathalyzers into the USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Stijloor Importing Address Books (Thunderbird and Outlook Express) into Windows Live Mail After Work and Weekend Discussion Topics 3
G Importing Medical Device Software to India - Diagnostic Imaging Application Other Medical Device Regulations World-Wide 8
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
S Exporting then re-Importing 510(k) device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Regulations for importing an IVD diagnostic test in India Other Medical Device Regulations World-Wide 16
bio_subbu CDSCO?s checklist on importing non-critical IVD products in India Other Medical Device Regulations World-Wide 1
amjadrana Importing Medical Devices with Computers as part of the device in Turkey Other ISO and International Standards and European Regulations 1
D Medical Device Regulations - Importing to Singapore - Orthodontic brackets Other Medical Device Regulations World-Wide 5
D How to obtain NOC from DCGI (Drug Controller General of India) for importing drugs Manufacturing and Related Processes 6
G Portocal II - Importing procedures Calibration and Metrology Software and Hardware 2
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
J US Manufacturer of Export Only Exempt Products applying for CFG 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
W Interesting Discussion Class I, GMP Exempt and IEC62304 IEC 62304 - Medical Device Software Life Cycle Processes 2
S Clarity on requirements for a 510k exempt Class I device - Suture removal kit US Food and Drug Administration (FDA) 9
O 510(k) Exempt OTC - Can we sell this device on Amazon? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Class I 510(k) exempt - Applicable Standards 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F IATF 16949 - Cl. 8.4.2.3 - Which type of suppliers could be exempt of ISO 9001 IATF 16949 - Automotive Quality Systems Standard 16
Q Is Medical Device 510(k) exempt or not really exempt? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom