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12-15 

How will my country's medical device industry develop in the next 10 years?

　　The development prospects of medical device companies seem optimistic, but medical costs are unsustainable, coupled with the participation of new competitive forces, indicating that the future pattern of the industry may change. If today's manufacturers fail to establish themselves in the ever-evolving value chain, they will face a dilemma and risk of being commercialized. To maintain a leading position, it is necessary to provide value beyond equipment and solve medical problems, rather than just contributing.

12-15 

A quick overview of drug regulatory policy: my country's 130th innovative medical device approved for listing!

　　On November 9, the State Food and Drug Administration approved the listing of biological hernia repair patches in accordance with the "Special Review Procedures for Innovative Medical Devices." This is the 130th innovative medical device approved for marketing since the establishment of the “special review channel for innovative medical devices” in 2014.

12-15 

The State Food and Drug Administration notified and investigated typical cases that can be used for medical aesthetics and medical device violations

　　According to the "Special Rectification Work Plan for Combating Illegal Medical Beauty Services" jointly issued by the National Health Commission, the Central Cyberspace Administration of China, the Ministry of Public Security, the General Administration of Customs, the General Administration of Market Supervision, the State Post Bureau, the State Drug Administration, and the State Administration of Traditional Chinese Medicine. ”And the “Notice of the Comprehensive Department of the State Drug Administration on Further Strengthening the Supervision of Medical Devices that Can be Used for Medical Aesthetics” requires that the drug regulatory department strengthens the supervision and inspection of medical device manufacturers and medical institutions in accordance with their duties, and investigates and deals with non-compliance with statutory requirements in accordance with the law Medical equipment. The State Food and Drug Administration actively organizes local drug regulatory agencies to carry out special rectification work against illegal medical beauty services. Localities have increased their supervision and law enforcement, severely cracked down on illegal activities that can be used for medical beauty and medical devices, and investigated and dealt with a number of cases of violations of laws and regulations, effectively safeguarding the legitimate rights and interests of patients.

10-22 

The State Food and Drug Administration issued 10 food and drug regulatory information standards

　　In order to steadily advance the construction of food and drug supervision information, implement the "Guiding Opinions of the State Food and Drug Administration on Further Strengthening the Construction of Food and Drug Supervision Information" (State Food and Drug Administration [2013] No. 32), and promote the food and drug supervision information system For interconnection, information sharing, and business coordination, the State Food and Drug Administration, based on actual needs and in accordance with the principle of urgent use first, organized the preparation of 10 food and drug regulatory information standards including the food and drug regulatory information standard system. It is now released through the official website of the State Administration of Taxation, and the food and drug regulatory authorities at all levels are invited to adopt it. In the process of preparation, the State Administration adopted the principle of open-door preparation, fully learned from the experience of relevant ministries and commissions, carefully listened to the opinions of authoritative experts in related fields, and solicited opinions from the food and drug regulatory system through various methods such as holding special meetings and printing and sending the draft for comments. , Through the official website of the General Administration of Public Solicitation of social opinions, and at the same time organized an expert review meeting to demonstrate 10 standards. 　　The 10 standards released this time include the food and drug regulatory informatization standard system, the basic terminology of food and drug regulatory informatization (information technology, drugs, and medical devices), the classification and coding standards for food and drug regulatory information, and the basic data of food and drug regulatory information Meta (General Provisions, Institutional Staff, Drugs, Medical Devices), Element Value Range Code of Basic Data of Food and Drug Supervision Information (General Provisions, Institutional Staff, Drugs, and Medical Devices Section), Metadata Specification for Food and Drug Supervision Information Data Sets, Food and Drug Supervision Data sharing and exchange interface specifications, food and drug regulatory application support platform general technical specifications, food and drug regulatory database design specifications, and food and drug regulatory software development process specifications.

09-12 

The State Council approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)"

　　On February 12, 2014, the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" was reviewed and approved by the executive meeting of the State Council and will be promulgated and implemented soon.

10-15 

Quality Management Systems (PDF document download)

10-10 

Questions and answers about 10 common questions about ethylene oxide sterilization

　　Q1: Which products are suitable for ethylene oxide sterilization? 　　A1: Ethylene oxide is widely used in medical disinfection and industrial sterilization. It is commonly used for gas fumigation and disinfection of foodstuffs, textiles and other methods that cannot be disinfected for thermally unstable drugs and surgical equipment, such as leather, cotton products, chemical fiber fabrics, precision instruments, biological products, paper, books, documents, and certain Medicines, rubber products, etc. In the medical industry, it is widely used in medical devices made of plastic, metal, non-woven fabrics and other materials, such as infusion sets, syringes, biopsy forceps, medical catheters, surgical gowns, surgical forceps, etc.

08-01 

Introduction to medical device packaging bags

　　Used for packaging of medical device products, it can be sterilized, can provide acceptable microbial barrier performance, can protect the product before and after sterilization, and can maintain the sterile environment inside the system within a certain period of time after sterilization. system.

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