Service & Tech

Regulatory Affairs
Regulatory Consultation

Regulatory ConsultationWith the constant change of regulations, application strategy and risk assessment are very important for the applicant. It is essential to understand regulations and transfer experience. Individualized services are needed to satisfy demands of the enterprises.Tiger

Agent Related Business

Agent Related BusinessWhen applying for registration/filing in China, foreign enterprises shall appoint corresponding agents to:Convey regulations to the manufacturer;Contact the corresponding food and drug administrations, foreign registration or recordation applicants;Convey regulation

Overseas Registtation

Overseas RegistrationWith the development and increasingly frequent communication of the medical device industry of China, domestic medical device manufacturers have increasinglystrong demand for export.Approval of the target country shall be obtained before export. Taking the U.S. as an examp

Product registration/filing

Product registration/filingMedical devices, which are/will be marketed and used in the People’s Republic of China, shall be registered/filed with the NMPA/competent local authorities.Including but not limited to:Filing/variation of Class I devices;First time registration of Class II and III d

Innovation Application Service

Innovation Application ServiceProducts (produced inside/outside China) conforming to innovation conditions of the Special Review Procedure of Innovative Medical Devices, can be applied for the innovation track. This trach allows Early communication and intervention, specific person for s

Product Classification Confirmation

Product Classification confirmationFor newly developed medical devices which are not included in the classification catalog and products whose category is not clearly identified, the applicant can determine the product category according to the classification rules and apply for category/attri