Own branding is a common practice for Medical devices. An Own Brand Labeler (OBL) purchases a finished (or component parts of a) Medical devices from the Original Equipment Manufacturer (OEM– CE Marked the Products), which he then places on the market under his own name or brand. This Own Brand Labeler may not be the person who actually designs, manufactures, packages or labels the device.
Certification is needed by the own brand labeler because, under EC directives, you become the legal manufacturer and take on all the legal responsibilities.
Points to be considered,
- Full cooperation of the OEM (Original Equipment Manufacturer) is mandatory.
- Documentary evidence of EC Certification of the original product is mandatory.
- The OEM product which is to be Own Brand Labeled must not be altered in anyway from the original product; (That is apart from Labels and Instructions For Use).
- Evidence for the OBL Products and OBL Products are functionally and Specifically same ,is mandatory.
- The OBL company must implement basic GMP controls to ensure integrity of product at all times.
- The OBL company must implement procedures to ensure that all necessary Post Sales Issues are effectively addressed (eg: Vigilance, Recall, Post Market Feedback etc etc).
- The OBL company must acknowledge that in Own Brand Labeling a product, they are accepting all responsibility for the product, as if they had manufactured the product themselves.
Malesh M
Regulatory Consultant
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Health Care Regulatory and QA Consultants 