Applying for Class I medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) involves the following:

⏱️ Processing Time

• Acknowledgment: The Medical Device Division (MDD) aims to acknowledge receipt of your application within 2 weeks of submission. 

• Review Period: The typical processing time for Class I device applications is up to 12 weeks, assuming all required documents are complete and accurate.

💰 Application Fees

As of now, the MDACS does not charge any application fees for the listing of Class I medical devices. This makes it a cost-effective option for manufacturers seeking to enter the Hong Kong market.

📌 Additional Notes

• Local Responsible Person (LRP): If you're an overseas manufacturer, appointing a Local Responsible Person in Hong Kong is mandatory. The LRP will handle the registration process on your behalf.

• Online Submission: All applications must be submitted through the Medical Device Information System (MDIS), the official online platform for MDACS.

• Documentation: Ensure that all required documents, such as device descriptions, manufacturing details, and conformity assessments, are prepared and submitted accurately to avoid delays.

For more detailed information and to start your application, visit the official MDACS website: MDACS Listing Application.