Medical devices 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.

Our company formation agents in Hong Kong can help you deal with import issues related to medical devices and products.

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, safety 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.

Our company formation agents in Hong Kong are able to provide complete information about the classification and registration of medical devices in the city. Our experts can also help you obtain the special permits and licenses required for import/export activities.

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