OEM / PLM Japan

V

vicky012

Registered
#1
#1
Dear Forum,

we are a european original equipment manufacturer of medical devices (class IIb). We want to cooperate with a business partner, who would act as a private label manufacturer and sell our products in his name with his own product name.
Is such a OEM PLM constellation in Japan? If so, are there specific requirements, like mentioning on the label that the product is manufactured by us? I already wrote the PMDA agency and they couldn't provide any Information for my query.

Thanks in Advance!
 
Download Free White Paper
Elsmar Forum Sponsor
U

UNIJP

Starting to get Involved
#2
#2
Yes, in this case, your company has to be registered as a manufacturer when the product is registered in Japan, and as far as I understand the name is printed on IFU.
Your business partner will be the legal manufacturer.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Can PLM be in the OEM position for another company? EU Medical Device Regulations 1
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
S OEM and PLM under MDR EU Medical Device Regulations 2
J OEM/OBL Problems: Solved by MDCG 2022-7 EU Medical Device Regulations 1
P Homologation responsibilities as OEM supplier Manufacturing and Related Processes 0
S Discussion on OBL and OEM test data for submission as per new EUMDR EU Medical Device Regulations 0
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
A Selling products with OEM certification expired EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 1
S CE marking for OEM Brand CE Marking (Conformité Européene) / CB Scheme 11
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
J Which OEM or customers are now requiring the new AIAG/VDA FMEA format? FMEA and Control Plans 7
A Calibration required by OEM General Measurement Device and Calibration Topics 2
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3
DuncanGibbons OEM specifications such as AIPS spec from Airbus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Sterilization Subcontractor of OEM ISO 13485:2016 - Medical Device Quality Management Systems 6
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
S Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen EU Medical Device Regulations 3
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
S Is Certificate of Conformance required for an OEM released product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Regulatory Responsibilities of an OEM and Private Label manufacturer Canada Medical Device Regulations 3
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
P Responsibility for Design Transfer - OEM vs. CM ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices Other Medical Device Regulations World-Wide 2
C How long is an OEM obligated to provide spare parts and repair EU Medical Device Regulations 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
C Relabeling Product Manufactured by the OEM 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S IMDS helper app or program or paid service at OEM? RoHS, REACH, ELV, IMDS and Restricted Substances 0
M Piggy Backing on OEM's CE certificate EU Medical Device Regulations 1
J CQI-9 - Can OEM do Oven Studies? Reliability Analysis - Predictions, Testing and Standards 1
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 6
M OEM vs OBL Classification in the CE Certification EU Medical Device Regulations 5
K Does OEM/OBL-Relationship need to involve an EU Authorized Representative? EU Medical Device Regulations 11
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
3 Brasil: OEM Medical Device Business - Product Design Customization Other Medical Device Regulations World-Wide 6
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
V Production Documents for Electrical/Electronic OEM Manufacturing and Related Processes 6

Similar threads

Top Bottom