CMHD & Co.

Medical device registration is a key requirement for market access worldwide. Given the territorial nature of regulatory frameworks, companies must tailor their submissions and appoint local representatives for each jurisdiction—such as the U.S. (FDA), the European Union (CE), China (NMPA), Southeast Asia, and notably, Hong Kong (MDACS).

 

We partner with MedDevice Global Solutions Company to deliver end-to-end medical device registration services, with specialised expertise in Hong Kong’s MDACS system. From device classification and technical documentation preparation to the appointment of a compliant Local Responsible Person ("LRP"), we help you achieve efficient, seamless, and fully compliant market entry - starting with Hong Kong and extending globally.

 

Although medical device registration in Hong Kong is voluntary under the Medical Device Administrative Control System ("MDACS"), obtaining a listing has become an industry standard that enhances product credibility and tender eligibility.

 

We are well-versed in the Department of Health’s requirements and can assist you in quickly establishing a qualified LRP and completing your MDACS application, providing a one-stop solution for compliance and registration.

 

We complement our partner’s strengths to create a win-win collaboration.

 

Our Services:

- One-stop MDACS application, business registration, and tax planning

- Rapid setup of a qualified LRP company

- Integrated financial and compliance framework to reduce long-term operational costs

 

Our Advantages:

- Familiar with review criteria and documentation formats, helping you resolve complex application issues

- Compliant LRP corporate structure design, avoiding rejection due to business registration deficiencies

- Cross-border tax planning, integrating MDACS compliance with import/export tax arrangements

- Risk isolation advice, using a standalone LRP company to reduce legal exposure for your parent entity

 

You may visit the following page for more information: Medical Device Listing Application