OSMUNDA Medical Device Service Group provides specialized product registration services for those medical device manufacturers and IVD reagent manufacturers who intend to place their products on the Chinese market. This consulting service, offered by the regulatory affairs (RA) team of OSMUNDA Group, involves a series of work related to the registration of medical devices and IVD reagents in National Medical Products Administration (NMPA).
The consulting service of NMPA registration is one of the core services that grow up with OSMUNDA from the outset. OSMUNDA Group has mature experience in NMPA registration and various optional pre-arranged plans, which can assist customers to adopt reasonable approaches. No matter what difficulties you encounter in the registration process, no matter what stage you are in, and no matter the size of your enterprise, you can find the suitable specialized services in OSMUNDA Group.
Main laws and regulations:
1. Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680 in
2017) promulgated on May 4, 2017
2. Provisions on Medical Device Registration (CFDA Order No. 4 in 2014) promulgated on July 30, 2014
3. Provisions on Registration of IVD Reagents (CFDA Order No. 5 in 2014) promulgated on July 30, 2014
Legal China Agent
Oversea manufacturer is required to appoint an authorized agent for the application of registration of the
imported medical devices and IVD products. Starting from November 2019, all authorized agents in China
needs to own a Certificate Authority for the purpose of electronic document submission. OSMUNDA Group
holds the CA and can act as your legal agent, as well as your regulatory consultant.
Similarly, an EAR serves as a legal entity designated by non-European Union (EU) manufacturers, to represent
them in the EU and ensure their compliance with the European Directives.