To apply for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to follow a structured process and submit your application to the Medical Device Control Office (MDCO). Here’s a detailed guide on how and where to apply.

1. How to Apply for Class C Medical Device Registration under MDACS

Step 1: Prepare Required Documents

• Before submitting the application, gather all the necessary documents. The required documents for Class C medical device registration include:
  • Application Form (MD-C2)
  • Device Description
  • Conformity Assessment Evidence (e.g., CE marking, ISO 13485 certification, FDA approval)
  • Risk Management Report (based on ISO 14971)
  • Clinical Evidence
  • Labeling and Instructions for Use (IFU)
  • Post-Market Surveillance Plan
  • Manufacturer’s Information
  • Local Authorized Representative (if applicable)
  • Declaration of Conformity

Step 2: Complete the Application Form (MD-C2)

• Download the MD-C2 Form from the MDCO website. The form is specifically designed for registering Class C medical devices.
• Complete all sections of the form accurately, providing details about the medical device, its intended use, manufacturer, and local representative.

Step 3: Submit Supporting Documents

• Ensure that all the supporting documents required by MDCO (as listed above) are included in your application.
• Organize the documents in a clear and logical order. Electronic submissions should be in PDF format, while physical submissions should be properly bound.

Step 4: Pay the Application Fee

• Pay the non-refundable application fee of HKD 5,060 for Class C devices. Follow the payment instructions provided by MDCO (typically bank transfer or check).

Step 5: Submit the Application

• You can submit your application to MDCO either electronically (via email) or physically (by mail or in person).

2. Where to Apply for Class C Medical Device Registration

Option 1: Apply Online (via Email)

• You can submit your completed application form and all required documents electronically via email.
• Ensure that the email attachments meet MDCO’s file size and format requirements (usually PDF).
• Contact MDCO via their official email address for submission guidelines:
  • Email: mdco@dh.gov.hk (or check the MDCO website for updated submission emails).

Option 2: Apply by Mail or In Person

• You can also submit the completed application form and all supporting documents in hard copy, either by delivering them in person or sending them by mail to the MDCO office.
• Submission Address:

  java复制代码Medical Device Control Office (MDCO)Department of Health, Hong Kong
  Room 3101, 31/F, Hopewell Centre,183 Queen's Road East, Wan Chai, Hong Kong

Option 3: Contact the MDCO for Clarification

• If you have specific queries regarding the application process, you can reach out to MDCO for clarification or assistance via phone or email:
  • Phone: +852 3107 8484
  • Email: mdco@dh.gov.hk

3. Key Considerations for Applying

• Completeness: Ensure all documents are complete, accurate, and meet the submission guidelines. Missing documents can lead to delays in processing.
• File Format: For electronic submissions, ensure documents are in PDF format and the file size is within acceptable limits.
• Language: Documents must be in English or Chinese. If documents are in another language, certified translations are required.
• Follow-Up: After submitting the application, be prepared to provide additional information if requested by MDCO.

By following these steps and submitting the application either online or by mail, you can successfully apply for Class C medical device registration under the Hong Kong MDACS system.

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