By Stewart Eisenhart, Emergo Group
Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.
The Hong Kong Medical Device Control Office’s (MDCO)list is intended as a reference for in-country representatives (Local Responsible Persons) in order to demonstrate safety and effectiveness of their manufacturers’ products.
The MDCO list includes standards from the International Standards Organization (ISO) and International Electrotechnical Commission (IEC). MDCO has included ISO 15223 for medical device symbols, but not EN 980, an older standard for device symbols.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.