that are imported to Hong Kong
are subject to pre-market entry approval and registration once they enter the city. The Medical Device Control Office
oversees medical devices and products
. While there is no current separate set of laws regulating the manufacturing and import of such products, Hong Kong imposes certain guidelines for this purpose and has its own regulatory regime for medicinal devices
The Pharmacy and Poisons Ordinance
and other legislative documents provide a framework for the regulation and control of medical devices. Foreign investors
who import medical products from other countries must also observe the legislation in place in the country of origin.
Pre-market entry medical devices verification in Hong Kong
A pre-market control for medical devices that enter Hong Kong is the verification of the product itself and of the trader. Medical devices are instruments used in treating or monitoring disease or injuries in human patients. They can also be used for rehabilitation purposes and they include a wide range of products, from cardiac monitors and pacemakers to more complex appliances or devices. The category does not include drugs or pharmaceutical products.
A medical device
that is imported to Hong Kong must comply with the standards in force and a pre-market control is useful for determining the quality
and effectiveness of the medical device
. As far as the trader is concerned, he may have to register as a manufacturer or importer of medical devices
Regulatory regime for medical devices in Hong Kong
The regulatory regime for medical devices in Hong Kong is developed in a manner that ensures the verification of the products. The aim is to consider the safety and quality of the medical products that enter Hong Kong.
Medical devices used in Hong Kong are separated into four classes, according to their risk level. Class I represents the highest risk and all medicinal devices must be classified in this manner.
The International Medical Device Regulators Forum (IMDRF) has an important role not only in defining the use of medical devices but also in creating a generally accepted regulatory regime for these types of products. The Hong Kong Government uses the regulatory principles set for the by the IMDRF and imposes a degree of control that is consistent with the certain level of risk a device may present to patients.