Hong Kong Local Responsible Person
Companies seeking to sell their medical devices in Hong Kong or IVD products to Hong Kong public hospitals must be listed in the MDACS (Medical Device Administrative Control System) database to meet procurement preference criteria.
Only a Local Responsible Person (LRP), which must be a registered Hong Kong entity, can handle the Listing application and perform various responsibilities such as managing regulatory obligations.
In addition, the Local Responsible Person has responsibility for post-market surveillance (PMS) such as adverse event reporting and ensures labeling compliance. Having an independent third party as an LRP can provide more control over the registration process and greater flexibility in managing distributors. Local Responsible Persons can also facilitate procurement processes for public hospitals, as MDACS-listed products receive preference.
Companies must apply for various classifications and registrations to ensure compliance with local health authorities and market readiness.
Can I Change My Hong Kong Local Responsible Person?
Yes, appointing a new Hong Kong Local Responsible Person is possible. Manufacturers often consider this when dissatisfied with their current agent, especially if the agent is also their distributor. In such cases, appointing an independent LRP like Cisema can provide greater transparency and control. Additionally, the benefits of appointing an independent Local Responsible Person include enhanced flexibility in distribution strategies and improved compliance with regulatory requirements.
Can I Become My Own Local Responsible Person in the Future?
Yes, this is quite common for manufacturers who grow and wish to establish their own operations in Hong Kong. This local company must satisfy the Hong Kong MDD’s regulatory requirements and is legally responsible for compliance during the entire product life cycle - which includes product registration, post market surveillance, and communication with authorities.
Cisema can remain contracted to help with communications and post market surveillance. Some manufacturers may take on this responsibility themselves once their local operations are ready. Handling these tasks in-house allows for better oversight. However, it requires hiring people who understand the regulatory rules in Hong Kong and any changes to them. Having a Local Responsible Person (LRP) to manage these regulatory obligations is crucial for IVD and medical device companies to ensure compliance and smooth operations.
Our Hong Kong Local Responsible Person Services
As your Local Responsible Person LRP in Hong Kong, we are your single point of contact for all Hong Kong Medical Device Division MDD matters. As we are independent of any distributor, we ensure that you maintain control of your product listings and retain an unconstrained choice of your market access partner(s), giving you full flexibility to adapt as necessary to changes in the market.
Our services include:
Applications
Post-Market Surveillance
Only a Local Responsible Person (LRP), which must be a registered Hong Kong entity, can handle the Listing application and perform various responsibilities such as managing regulatory obligations.
In addition, the Local Responsible Person has responsibility for post-market surveillance (PMS) such as adverse event reporting and ensures labeling compliance. Having an independent third party as an LRP can provide more control over the registration process and greater flexibility in managing distributors. Local Responsible Persons can also facilitate procurement processes for public hospitals, as MDACS-listed products receive preference.
Companies must apply for various classifications and registrations to ensure compliance with local health authorities and market readiness.
Request a Proposal from Our Life Sciences Team about Appointing Us as Your Local Responsible Person in Hong Kong
Let Cisema help turn your plans into reality.
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