top of page

Medical Devices



Medical Devices


Hong Kong is a major hub for medical devices in Asia. The medical device industry in Hong Kong is well-developed and regulated by the Medical Device Division (MDD) of the Department of Health. The MDD is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term statutory regulatory framework for medical devices.


There are a wide variety of medical devices available in Hong Kong, from simple bandages and thermometers to complex surgical instruments and diagnostic equipment. Here are some of the different types of medical devices that can be found in Hong Kong:


  • Diagnostic devices: These devices are used to diagnose medical conditions. Examples of diagnostic devices include X-ray machines, ultrasound machines, and blood test kits.

  • Therapeutic devices: These devices are used to treat medical conditions. Examples of therapeutic devices include pacemakers, stents, and artificial limbs.

  • Assistive devices: These devices are used to help people with disabilities live more independent lives. Examples of assistive devices include wheelchairs, hearing aids, and prosthetics.


If you are looking for medical devices in Hong Kong, there are a number of places you can look. Here are a few suggestions:


  • Medical device suppliers: There are many medical device suppliers in Hong Kong. These suppliers can sell you a wide variety of medical devices, from simple bandages to complex surgical instruments.

  • Hospitals and clinics: Many hospitals and clinics in Hong Kong sell medical devices to their patients.

  • Pharmacies: Some pharmacies in Hong Kong sell medical devices.


When choosing a medical device, it is important to consider your needs and to consult with a doctor or other healthcare professional.


Legislative Control of Medical Devices


Interestingly, Hong Kong's legislative control of medical devices is a bit unique. Here's the breakdown:


  • No Specific Legislation Yet: As of today (April 3, 2024), there's no single, overarching law specifically regulating all medical devices in Hong Kong.

  • Fragmentary Regulation: Some devices are regulated by existing ordinances based on their characteristics. For instance, the Pharmacy and Poisons Ordinance or the Radiation Ordinance might apply.

  • Voluntary System in Place:  The Department of Health (DoH) runs a voluntary Medical Device Administrative Control System (MDACS). This system includes:

  • Listing System: Manufacturers and importers can voluntarily list their devices with the DoH.

  • Adverse Event Reporting: There's a system for reporting problems with medical devices.

  • Statutory Framework Proposed: The government has proposed a risk-based framework for regulating medical devices, similar to international guidelines. However, legislation for this framework is still pending.


Regulation of Medical Devices


Hong Kong's regulation of medical devices is currently in a transitional phase, moving towards a mandatory system. Here's a breakdown of the key points:


Current System (Voluntary):


  • Medical Device Administrative Control System (MDACS): This is a voluntary program run by the Medical Device Division (MDD) of the Department of Health (DoH).

  • Classification: Devices are classified based on risk (Class I - Lowest, Class IV - Highest).

  • Registration: Only Class II, Class III, and Class D In Vitro Diagnostic (IVD) devices are eligible for voluntary registration under MDACS.

  • Benefits of Registration:

  • Increased credibility with hospitals and government bodies.

  • May become mandatory in the future.


Future System (Mandatory - Proposed):


  • Statutory Framework: The government is developing a mandatory regulatory framework based on international guidelines.

  • Risk-Based Approach: Similar to MDACS, devices will be classified by risk, with most requiring registration.

  • Increased Scrutiny: This framework is expected to involve stricter controls and potential pre-market approval for higher-risk devices.


Important Notes:


  • The proposed mandatory framework is still pending legislation.

  • Devices for veterinary use are not included in the MDACS system.

  • Some devices with specific features (e.g., containing drugs or emitting radiation) might be subject to regulations under other ordinances.


Sources



Here are some resources for further reading:



Resources:


7 views0 comments

Recent Posts

See All

Comments


bottom of page