The purpose of handling Class A medical device registration under Hong Kong MDACS is to ensure that low-risk medical devices meet essential safety, quality, and performance standards before they are sold and used in the Hong Kong market. The Medical Device Administrative Control System (MDACS) provides a streamlined regulatory process designed to protect public health while allowing easier access to the market for low-risk devices.

Key Purposes of Class A Medical Device Registration under MDACS

1. Ensuring Public Safety:

   • Primary Purpose: The registration process helps safeguard public health by ensuring that medical devices, even those categorized as low-risk, meet the necessary safety and quality standards.

   • Risk Mitigation: Although Class A devices are considered low-risk, the registration process ensures that they do not pose any danger to users, patients, or healthcare professionals.

2. Market Access:

   • Legal Marketing: Registration allows manufacturers to legally market and distribute their medical devices within Hong Kong.

   • Facilitation of Trade: For international manufacturers, obtaining registration under MDACS enables smooth access to the Hong Kong medical device market.

3. Regulatory Compliance:

   • Legal Requirement: In Hong Kong, Class A medical devices must be registered with the Department of Health under MDACS in order to be legally sold or distributed.

   • Adherence to Standards: The registration process ensures that the device complies with essential regulations, standards, and requirements for manufacturing, safety, and efficacy.

4. Transparency and Traceability:

   • Device Traceability: By registering the device, it becomes traceable in the system, which allows for tracking in case of recalls or issues post-market.

   • Documenting Compliance: Registration ensures there is a record of the device's technical documentation, risk assessments, and declarations of conformity, enhancing traceability and transparency.

5. Post-Market Surveillance:

   • Monitoring Safety and Performance: Once registered, manufacturers must continue to monitor their devices in the market. Registration ensures that there is a system in place for reporting adverse events or product defects.

   • Continuous Compliance: It establishes a process for manufacturers to comply with ongoing post-market requirements, ensuring that safety and performance standards are upheld over time.

6. Consumer Confidence:

   • Trust in Products: Registration helps build consumer and healthcare professional confidence in the device, as they can be assured that it has been tested, documented, and authorized by a recognized regulatory body (Hong Kong Department of Health).

   • Credibility in the Market: It provides a level of assurance that the device meets the local standards, which is particularly important in healthcare settings.

7. Facilitating International Trade:

   • Harmonization with Global Standards: Hong Kong's MDACS aligns with international standards (e.g., ISO 13485, ISO 14971), which makes it easier for manufacturers to export to or trade within other markets with similar regulatory requirements.

   • Ease of Export: For manufacturers based in other countries, obtaining Class A registration under MDACS can help with entering the Hong Kong market and complying with local regulations for smoother trade and distribution.

Conclusion:

The purpose of handling Class A medical device registration under Hong Kong MDACS is to ensure that medical devices are safe for use, comply with relevant standards, and can be legally marketed in Hong Kong. This process helps protect public health, promotes regulatory compliance, and facilitates market access for manufacturers, all while ensuring continuous monitoring and transparency throughout the lifecycle of the device.

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