OBL Agreement Typical

OWN BRAND LABELLING SERVICE CONTRACT
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DEFINATIONS
Private Label :
xyz
Private Label Manufacturer :

[ address ] xyz inc ;
Jfsdjfjdkf
AddjhjkJ
usa
OEM Producer :
[ address ]
This Own Brand Labeling contract (hereinafter referred as OBL

contract) is made as of date …… between :
(1) xyz inc (hereinafter referred to as Private label Manufacturer) and
(2) abc (hereinafter referred to as the OEM Producer)
SCOPE OF THE CONTRACT:
The scope of this contract covers all the products manufactured and
CE certified by the OEM producer, like the Digital Thermometers,
Patient Monitors, Pulse oximeters and Pulse Oximetry sensors. Any
addition of products or product groups not covered by above will have
to be done by an amendment to this contract.
PERIOD OF VALIDITY:
This Own Brand Labeling contract is valid for three years from the date
of sign off and will be further valid for the same period unless otherwise
amended or cancelled in writing by both parties
RESPONSIBILITIES OF THE PRIVATE LABEL MANUFACTURER:
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1. PRODUCT DESCRIPTION and TRACEABILITY: To maintain a

document describing the changes that are made to the product of
the OEM producer, and the list of traceability between the OEM
producers products name and code to that of MEDIAID Inc.,
2. DECLARATION OF CONFORMITY: To establish a Declaration

of conformity and a declaration that the OEM producer’s products
and the private label device are identical except for
Manufacturer’s detail on the product label and Instructions for
use document.
3. ESTABLISHED PROCEDURES: To establish a procedure for the

post market surveillance, vigilance, product recalls and any
advisory notices, labeling and packaging procedure and storage
and handling procedure.
4. IDENTIFICATION AND TRACEABILITY: To establish proper

references number / Serial numbers for the products and to have
a tracking of the same after delivery.
5. NON-CONFORMING PRODUCTS: To have a system of

distinguish non conforming product and prevent same from
getting back into market
6. CORRECTIVE AND PREVENTIVE ACTIONS : To collect and

assess all information for corrective and or preventive action and
communicate same periodically to the OEM
7. CUSTOMER COMPLAINTS : to address Customer complaints
and resolve and interact with OEM if need be for resolution and
communication for driving any necessary actions at the OEM
RESPONSIBILITIES OF THE OEM PRODUCER :
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1. ACCESS TO TECHNICAL DOCUMENTATION: To permit the

notified body of the Private Label manufacturer the access to the
technical documents within a reasonable timeframe in case of
reporting of any incidents.
2. INFORMING SUBSTANTIAL CHANGES: To inform the Private

Label manufacturer of any substantial changes to the product
design or about any withdrawal / suspension of applicable CE
certificates of the products.
3. QUALITY SYSTEM: To implement a quality management system

in line with ISO 13485: 2003 and be Certified by a recognized
certifying body, and share a copy of the certificate with the
Private label manufacturer. .
4. DESIGN AND DEVELOPMENT AND DESIGN RELEASE:

Maintain and keep the current updated Technical file for all
products manufactured and make available same for notified
body or Private Label Manufacturer as and when necessary
within reasonable time
5. PROCESS CONTROL: Validations of any processes as

necessary and maintaining controlled production conditions for
manufacturing, testing, storage and delivery, as per the product
specifications.
6. QUALITY RECORDS: Records of product verification to be maintained

and held in archive per established procedures for record control and
retention.
7. DECLARATION OF CONFORMITY: To establish a Declaration of

conformity and a declaration that the OEM producer’s products and the private
label device are identical except for Manufacturer’s detail on the product label
and Instructions for use document.
8. INSTALLATION AND SERVICING: To provide to the Private

label manufacturer the instructions for installation and servicing
of the products delivered.
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9. LIST OF CONTACTS:
NAME FUNCTION MAIL and PHONE
Mr. asdff Customer support
Mr. ghjk Production
Mr. zxcv Quality
SIGNATURE:
DESIGNATION:
ceo
DATE :
FOR :
Private Label Manufacturer :
xyz inc;
USA
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SIGNATURE:
DESIGNATION:
DATE :
FOR :
OEM Producer :
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OBL Agreement Typical

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What are the responsibilities of the private label manufacturer?

What are the responsibilities of the private label manufacturer?

What are the responsibilities of the OEM producer?

What are the responsibilities of the OEM producer?

OWN BRAND LABELLING SERVICE CONTRACT

Private Label Manufacturer :

This Own Brand Labeling contract (hereinafter referred as OBL

(2) abc (hereinafter referred to as the OEM Producer)

SCOPE OF THE CONTRACT:

RESPONSIBILITIES OF THE PRIVATE LABEL MANUFACTURER:

1. PRODUCT DESCRIPTION and TRACEABILITY: To maintain a

2. DECLARATION OF CONFORMITY: To establish a Declaration

3. ESTABLISHED PROCEDURES: To establish a procedure for the

4. IDENTIFICATION AND TRACEABILITY: To establish proper

5. NON-CONFORMING PRODUCTS: To have a system of

6. CORRECTIVE AND PREVENTIVE ACTIONS : To collect and

RESPONSIBILITIES OF THE OEM PRODUCER :

1. ACCESS TO TECHNICAL DOCUMENTATION: To permit the

2. INFORMING SUBSTANTIAL CHANGES: To inform the Private

3. QUALITY SYSTEM: To implement a quality management system

4. DESIGN AND DEVELOPMENT AND DESIGN RELEASE:

5. PROCESS CONTROL: Validations of any processes as

6. QUALITY RECORDS: Records of product verification to be maintained

7. DECLARATION OF CONFORMITY: To establish a Declaration of

8. INSTALLATION AND SERVICING: To provide to the Private

NAME FUNCTION MAIL and PHONE

Mr. asdff Customer support

Mr. ghjk Production

Mr. zxcv Quality

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