The registration cycle for Class A medical devices under Hong Kong's Medical Device Administrative Control System (MDACS) is relatively straightforward and shorter compared to higher-risk devices (Classes B, C, and D). The process focuses on ensuring that low-risk devices meet essential safety and performance standards before being allowed on the market.

Here’s an overview of the registration cycle for Class A medical devices under MDACS:

1. Initial Registration

• Duration: The registration process for Class A devices is typically fast and can take anywhere from a few weeks to a couple of months, depending on the completeness of the application and the Department of Health’s workload.

• Application: You must submit your application through the MDACS online portal. This includes providing all required documents, such as:

  • Device description

  • Manufacturer details

  • Compliance with relevant international standards (e.g., ISO 13485, ISO 14971)

  • Labeling and instructions for use (IFU)

  • Declaration of conformity

  • Risk management documentation

• Review Process: The Department of Health will review the application for completeness and conformity to regulatory requirements. They may request additional information if necessary.

• Approval: If the application meets the necessary criteria, the device will be approved, and you will receive a registration certificate and registration number.

2. Registration Validity

• Once a Class A device is successfully registered, the registration is typically valid for 5 years. During this time, the device can be marketed and distributed in Hong Kong.

• The registration certificate will specify the validity period, and it is important to track this period to ensure continuous compliance.

3. Post-Market Surveillance

• Ongoing Monitoring: After registration, the manufacturer or authorized representative must implement a post-market surveillance system to monitor the device's safety and performance once it is on the market.

• Adverse Event Reporting: If any adverse events occur (e.g., device malfunctions, safety concerns), these must be reported to the Hong Kong Department of Health in accordance with regulatory requirements.

4. Periodic Updates or Renewals

• Renewal: Before the registration expires (typically after 5 years), you will need to renew the registration. While the process for renewal is generally less extensive than the initial registration, you may still be required to submit updated information or documentation about the device.

• Application for Renewal: You can apply for renewal through the MDACS online portal. Ensure that all information is up to date, and submit any additional information or updated documents requested by the Department of Health.

5. Changes to the Device

• If there are any significant changes to the device (e.g., design modifications, changes in manufacturer), you must notify the Department of Health and, in some cases, re-submit relevant documentation for review and approval.

• Regulatory Compliance: Any changes must still comply with regulatory standards, and devices must meet the necessary safety, quality, and performance criteria.

6. Withdrawal or Suspension

• If the device is found to have safety issues or does not meet the regulatory requirements, the Department of Health has the authority to suspend or withdraw the registration. In such cases, the device cannot be marketed or sold in Hong Kong.

Summary of the Class A Registration Cycle

1. Initial Registration: Submit the application, review process, and approval (usually a few weeks to a couple of months).

2. Validity: Once approved, the registration is valid for 5 years.

3. Post-Market Surveillance: Ensure ongoing monitoring, and report adverse events.

4. Renewal: Apply for registration renewal before expiration (after 5 years).

5. Device Changes: Report significant changes to the device and ensure continued compliance.

6. Suspension/Withdrawal: If the device no longer meets safety or regulatory requirements, it may be suspended or withdrawn.

Key Takeaways

• Class A medical device registration under MDACS involves a streamlined process, with a 5-year validity period.

• Renewals are required after 5 years, and changes to the device must be reported.

• Post-market surveillance and adverse event reporting are essential for ongoing compliance.

By staying on top of regulatory requirements, ensuring post-market surveillance, and preparing for renewals, manufacturers can maintain their device's registration status in Hong Kong under MDACS.

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