Animal Experiment StudyThe animal experiment is an important part of preclinical study for medical devices and an important bridge connecting basic research and the clinical trial. Tt is expected to obtain new biological and medical knowledge or solve specific problems, and preliminarily verify the
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 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 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/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 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 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
Clinical OperationOverviewTigermed-Jyton has always been devoted to providing integrated technology and support for clinical trials intended for the registration of medical devices and IVD products. We will support your registration or pre-marketing study from protocol design, center screening
Quality Control (QC)OverviewTigermed-Jytonexercises quality control over clinical trials for medical devices and IVD products, to ensure that the company’s clinical trial projects conform to relevant laws, regulations and SOP of the company.1.Service contents:1)Project QC, i
Medical Writing Service1. Service Contents1) Design of clinical trial protocols for medical devices/different phases of clinical trial protocols or unconventional study protocols for drugs2) Preparation of clinical protocol attachments (e.g., case report forms medical history, informed c
