Medical Device Contract Manufacturer - Does the CM need to register with FDA?

#1
Hi,
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.

Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?

Please help...

Thanks In advance
 

somashekar

Staff member
Super Moderator
#3
Hi,
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.

Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?

Please help...

Thanks In advance
YES for your establishment registration, and that will need an US agent.
Your QMS must be in line with the 21 CFR 820.
You may be inspected by FDA at their own discretion
You have to list the devices you make and ship to your OEM in USA using the 510k number of your OEM, and put your status as Contract manufacturer. You will then have a listing number (D number) unique to your listing which will be generated in the FDA portal upon successful lisitng, and you may have to keep this listing number for each device known to you and share with your OEM when asked at any point of time.
You will also have your establishment registration number, and you will have to renew the registration annually before Dec for the successive year by payment of the prescribed fee which will be known well in advance. The fee is not the same each year.
Please also check with your OEM how you need to use these numbers in your shippment invoice to them.
 

LUFAN

Involved In Discussions
#4
As of a Final rule in 2012, yes.

Elimination of Registration and Listing Exemptions for Contract Manufacturers and Sterilizers Who Do Not Commercially Distribute the
Devices
Under current § 807.20(a)(2), (c)(1), and (c)(2), contract manufacturers and contract sterilizers are exempt from registration and listing obligations if they make or sterilize a device according to another person’s specifications for commercial distribution by the person who
developed the specifications. This final rule will eliminate the exemption from registration and listing for contract manufacturers and contract sterilizers who do not commercially distribute. Contract manufacturers and contract sterilizers not currently registering will be required to do so. Registration and listing is a recurring obligation, so there are annual costs associated with this impact .

According to federal register Vol. 77 No.149:
<https://www.govinfo.gov/content/pkg/FR-2012-08-02/pdf/2012-18764.pdf>

Another good FDA reference in addition to the one @somashekar referenced: Overview of Device Regulation
 
Thread starter Similar threads Forum Replies Date
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S 21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing Other US Medical Device Regulations 1
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
R Role of Contract Manufacturer - MDRs (Medical Device Reporting) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Contract Manufacturer - Product Identification for Combination medical device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
W Contract Initial Importer and Order Handling for a Class I Medical Device Service Industry Specific Topics 2
M New Medical Device Contract Manufacturers Excise Tax Requirements US Food and Drug Administration (FDA) 8
A Medical Device Contract Manufacturer Registration 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 34
L Class 1 Medical Device Contract Manufacturer Technical File Requirements Design and Development of Products and Processes 3
G LST (Device Listing Number) for Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
D Sub-Contract Manufacturing of a Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer Document Control Systems, Procedures, Forms and Templates 5
C Regulatory Requirement Updates? Medical Device Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 6
R Medical Device Contract Manufacturer doesn't know ISO 14971 3.4 a) Life Cycle Phases ISO 14971 - Medical Device Risk Management 3
F Quality Manual Template for ISO 13485 - Small Contract Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
E Conformity Assessment choices for a Contract Manufactured Class IIa Medical Device Other US Medical Device Regulations 1
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
W Financial Risk for Contract Manufacturer Partnering a Medical Device Manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D FDA Audit - who is "eligible"? Medical Device Sub-Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
T Korean requirements for foreign medical device contract manufacturers? Japan Medical Device Regulations 2
C Contract Manufacturing of Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 11
S Looking for USA Medical Device Contract Manufacturer - Suggestions? ISO 13485:2016 - Medical Device Quality Management Systems 12
V Records of Obsolete Medical Device(s) for Contract Manufacturers Records and Data - Quality, Legal and Other Evidence 6
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 0
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
N Medical device name in different countries EU Medical Device Regulations 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom