Port communicationHong Kong Xintong-Today I will introduce to you the relevant knowledge about medical device innovation，Let’s learn together! As the scale of the medical market gradually increases,，National regulatory authorities have also formulated relevant policies and systems，To promote structural adjustment and technological innovation in the pharmaceutical and medical device industry，Improve industrial competitiveness，Meet the clinical needs of the public。
An excerpt from the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" is as follows：one、Accelerate the review and approval of urgently needed clinical drugs and medical devices。Drugs and medical devices that are of great significance for treating serious life-threatening diseases for which there is no effective treatment and other drugs and medical devices that are of great significance in meeting clinical needs.，Early clinical trials、Interim indicators that demonstrate efficacy and predict clinical value，May be conditionally approved for listing。
Applicants must develop a risk management plan，according to
Require
Carry out confirmatory clinical trials and complete the research content specified in the approval document。Encourage the research and development of innovative drugs and medical devices，Innovative drugs and medical devices supported by major national science and technology projects and national key research and development plans，Grant priority review and approval。two、Support the research and development of rare disease treatment drugs and medical devices。List of rare diseases published by the health and family planning department，Establish a rare disease patient registration system。
Applicants for rare disease treatment drugs and medical devices may apply for clinical trial exemptions，Accelerate the review and approval of rare disease drugs and medical devices。For rare disease treatment drugs and medical devices that have been approved for marketing abroad，May be conditionally approved for listing，Conduct relevant research within the specified time after listing。three、Improve the drug and medical device review system。form a review-led、Technical review system supported by inspection and inspection。
Establish mainly clinical medical professionals，Pharmacy、Pharmacology and Toxicology、A drug review team composed of statistics and other professionals is responsible for the review of new drugs；Established by clinical medicine、clinical diagnosis、mechanical、electronic、Material、A medical device review team composed of biomedical engineering and other professionals is responsible for the review of innovative medical devices。Establish a project manager system，Responsible for the communication and organization of meetings between applicants and reviewers，Reviewers are prohibited from communicating with applicants privately。
Establish a communication system for meetings between reviewers and applicants during the project review process，Before filing for Phase I clinical trial、After the completion of the II clinical trial, before the start of the Phase III clinical trial, and before the application for production and marketing after the completion of the Phase III clinical trial, there are three important nodes，A meeting between the applicant and the reviewers must be held for full discussion and exchange。review period，Meetings and exchanges can be arranged at the request of the applicant。
Establish an expert advisory committee system，Major technical disputes are publicly discussed by the expert advisory committee，Hear applicants、Reviewers provide comments after both sides’ comments，For reference in decision-making。All review conclusions of the review agency are disclosed to the public (except for business secrets involving the company's production processes and parameters)，Accept social supervision。Unify technical standards for review of Class II medical devices，Create conditions to gradually realize unified national review。
Medical treatment is closely related to our healthy life，every step of its progress、every innovation，All increase confidence in mankind’s ability to overcome disease and pain.，for every country、Add harmony to the family。Thanks to those who worked hard on this! With medical "health" ，Our health will be protected! Compliance and legal operation，Start with "health"! If you still need to know more about this，You are welcome to consult Hong Kong Xintong at any time!
About Hong Kong Xintong
Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。
