Hello, everyone.
I would like to have advice from you.
eMDR becomes effective on August 14, 2015. According to FDA, importers and "manufactures" comply with this new rule. Adverse event reporting must be sent to electronically via Internet after August 14.
http://www.fda.gov/MedicalDevices/D...ectronicMedicalDeviceReporting/UCM2019327.htm
FDA's definition of manufactures is;
Sec. 820.3 Definitions.
(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
Here are my questions is;
My company consists of four establishments. One sales office in US (Importer), one head office / design office, (manufacturer), and two factories, (manufacturer), outside of US.
According to the FDA definition, the head office / design office and the factories are considered as "manufacturer". Does this mean that all these "manufacturers" must have eMDR system individually? We, manufacturers, don't have people who can read English documents and understand how computer works and communicate with FDA directly. We always rely on our staff in US. I understand FDA demands eMDR for us but considering risk of our products, our products will never cause death or sever injury. Do we really have to hire new employers just for what is not likely happen?
Or is there any good way to avoid eMDR legally?
I appreciate your help very much.
I would like to have advice from you.
eMDR becomes effective on August 14, 2015. According to FDA, importers and "manufactures" comply with this new rule. Adverse event reporting must be sent to electronically via Internet after August 14.
http://www.fda.gov/MedicalDevices/D...ectronicMedicalDeviceReporting/UCM2019327.htm
FDA's definition of manufactures is;
Sec. 820.3 Definitions.
(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
Here are my questions is;
My company consists of four establishments. One sales office in US (Importer), one head office / design office, (manufacturer), and two factories, (manufacturer), outside of US.
According to the FDA definition, the head office / design office and the factories are considered as "manufacturer". Does this mean that all these "manufacturers" must have eMDR system individually? We, manufacturers, don't have people who can read English documents and understand how computer works and communicate with FDA directly. We always rely on our staff in US. I understand FDA demands eMDR for us but considering risk of our products, our products will never cause death or sever injury. Do we really have to hire new employers just for what is not likely happen?
Or is there any good way to avoid eMDR legally?
I appreciate your help very much.