The process for Class I medical device MDACS registration in Hong Kong follows a structured approach, ensuring compliance with the Medical Device Administrative Control System (MDACS) governed by the Department of Health (DH). Here are the key steps involved in the registration process:

1. Preliminary Preparation

Before starting the registration process, make sure you have the following:

• Determine Classification: Verify that the device is classified as Class I under the MDACS. Class I devices are typically low-risk devices that are subject to minimal regulatory control.

• Establish a Local Responsible Person (LRP): If your device is manufactured outside Hong Kong, you must appoint a Local Responsible Person (LRP) who will act as the liaison between the manufacturer and the Department of Health (DH).

2. Register with MDACS

The first step is to formally register the medical device with the Department of Health (DH) in Hong Kong.

• Create an Online Account: To begin the registration process, create an account on the MDACS online portal (accessible via the DH’s official website).

• Register the Device: You will need to complete the online application form to register your device. Provide the following details:

  • Device Name and Manufacturer Information.

  • Device Classification (to confirm it's a Class I device).

  • Intended Use of the device.

  • Detailed Description of the device and its intended function.

  • Importers and Distributors (if applicable).

3. Prepare and Submit Technical Documents

To complete the MDACS registration, you need to submit specific technical documents that demonstrate the safety and efficacy of the device.

Required Documentation:

• Device Description: A brief overview of the device, including technical specifications and intended use.

• Risk Management File: Documentation that outlines the risk assessment of the device, identifying potential hazards and controls in place.

• Labeling Information: This includes product labels, instructions for use (IFU), and packaging details. Ensure that these meet the Hong Kong labeling requirements, including language and content.

• ISO 13485 Certification (if applicable): If your manufacturing facility follows ISO 13485 (Quality Management Systems), include the relevant certificates.

• Clinical Evidence (if applicable): For some Class I devices, evidence of clinical trials or performance data may be needed to support the registration.

4. Review by the Department of Health (DH)

After submitting the required documents, the Department of Health will review your application. The review will include checking the following:

• The accuracy and completeness of the application.

• Compliance with Hong Kong’s medical device regulations.

• The conformity of the device with international standards such as ISO 13485 or the European Medical Device Regulation (MDR) (if applicable).

5. Issuance of Registration Certificate

Once the Department of Health has reviewed and approved the application, they will issue a registration certificate for your Class I medical device. The approval confirms that the device is legally registered for sale and use in Hong Kong.

6. Post-Registration Responsibilities

After obtaining the registration certificate, the device is legally available for sale in Hong Kong. However, you have ongoing responsibilities:

• Adverse Event Reporting: You must report any adverse events or safety issues related to the device.

• Post-Market Surveillance: You need to monitor the device's performance in the market and ensure it complies with safety standards.

• Renewal and Updates: While Class I devices may not need frequent re-registration, you must notify the DH about any significant changes to the device or the manufacturer’s details. Also, ensure that your device complies with any regulatory updates issued by the DH.

Summary of Steps for Class I Medical Device MDACS Registration:

1. Prepare for Registration:

   • Verify the device classification.

   • Appoint a Local Responsible Person (LRP), if applicable.

2. Create an Online Account and Register the Device via the MDACS portal.

3. Prepare and Submit Technical Documentation, including:

   • Device description, risk management, and clinical data.

   • Labeling and instructions for use.

   • ISO certifications (if applicable).

4. Department of Health (DH) Review:

   • DH will evaluate the submitted materials and ensure regulatory compliance.

5. Issuance of Registration Certificate:

   • Once approved, you will receive the registration certificate, allowing the device to be marketed in Hong Kong.

6. Post-Registration Compliance:

   • Monitor the device, report adverse events, and maintain compliance with ongoing regulatory requirements.

By following these steps, you can successfully register your Class I medical device under MDACS in Hong Kong, ensuring that your device meets safety, quality, and regulatory standards.

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