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RICHWAY & FUJI BIO INC
Biomat vs Copycat
"Why are copycat products illegal?"
Copycat Products Lack All Eight Essential Certifications of a Medical Device as
GMP
Our Biomats are medical devices, manufactured with GMP certification, ensuring the highest quality standards in the industry.
GMP (Good Manufacturing Practice) manufacturing is a set of quality control and assurance standards that are applied to
the manufacturing of pharmaceuticals, medical devices, and other healthcare products.
ISO 13485
We follow ISO 13485 regulations in our production processes, ensuring that our devices are safe and effective for our customers.
ISO 13485 is an international standard that outlines the requirements for a quality management system in the design, development,
production, installation, and servicing of medical devices.
NRTL certification
We have obtained NRTL certification for our products, which demonstrates our commitment to electrical safety and compliance with regulations.
NRTL stands for Nationally Recognized Testing Laboratory.
NRTL certification is a third-party certification program provided by laboratories that have been recognized by the Occupational
Safety and Health Administration (OSHA) in the United States.
MDSAP
We comply with all mandatory regulations in Canada, including MDSAP certification and Class 2 medical device licenses,
to ensure the safety of our products.
MDSAP stands for Medical Device Single Audit Program.
It is a program that allows medical device manufacturers to undergo
a single audit of their quality management system that satisfies the regulatory requirements of participating countries.
CAPA
We take CAPA (Corrective and Preventive Action) management seriously, ensuring that all issues are promptly identified,
corrected, and prevented to ensure the highest quality of our products.
510K premarketing notification
Our Biomat, which has received FDA approval, is classified as a Class 2 medical device and has obtained
a 510K premarketing notification, ensuring compliance with all medical device regulations.
UDI
Our products feature UDI numbers, ensuring accurate customer management and providing peace of mind to our users.
UDI stands for Unique Device Identifier. UDI numbers are unique codes assigned to medical devices.
UDI stands for Unique Device Identifier. UDI numbers are unique codes assigned to medical devices.
Health Canada License
Our Biomat has obtained approval from Health Canada, is classified as a Class 2 medical device, and has obtained a Medical Device License, ensuring compliance with all Canadian medical device regulations. Compliance with the License is mandatory, and failure to comply will result in recall.
