Medical Device Registration
China is one of the most difficult regions in the world to get medical device registered, due to the complex supervising systems, special requirements, and culture issues, particularly for foreign companies.
The overseas manufacturers, if their products would like to be sold in China, a China legal agent is necessary, and the product must get NMPA approval first.There are lots of work to do before submitting a registration dossier to NMPA, such as compile the Product Technical Requirements (PTR), product type testing in a Chinese accredited test lab, clinical investigation (might be a clinical trial or clinical evaluation), as well as documentation localization.
The state council is pushing all the government departments and industries to move forward the electronic process for all the administrative actions, the medical device registration’s online submission (eRPS) has been implemented on May. 10, 2019, it brought a lot of conveniences, but in the meantime, the submission dossier needs to be restructured.
As the medical device administration system’s revolution is still on the way, regulations are keep updating, the industry has to be prepared for timely changing the regulatory strategy.
Different from the traditional consultant companies in the field, we built automated systems using SaaS so that to enhance the workflow and make our work more efficient.
As the authorities strengthen the requirements on China legal agent and local distributors for the imported medical devices, many consultant companies or distributors refused to be the legal agent anymore due to the resources issues and liabilities.All our advisors are from global leading medical technology providers, with different kinds of medical device regulatory affairs experience, plus our system, we can continue monitoring regulations, adapting the strategies, tracking post-market actions, and providing constructive suggestions for our clients.