Recently, the State Administration for Market Regulation issued the "Medicine Device Production Supervision and Administration Measures" and the "Medicine Device Operation Supervision and Administration Measures". The two documents will come into effect on May 1, 2022.
This management method has been modified from five major directions: First, implement the medical device registrant and filing system, and strengthen their quality and safety responsibilities throughout the life cycle. The second is to strictly implement the spirit of the "deregulation, supervision and service" reform and simplify relevant application materials and procedures. The third is to clarify the supervision and inspection powers and strengthen supervision measures. Fourth, increase regulatory measures to solve the problem of insufficient regulatory measures. Fifth, strengthen law enforcement supervision and promote fair and honest law enforcement.
further strengthens the corporate quality responsibility:
- requires enterprises to engage in medical device operations, establishes quality management systems and quality control measures covering the entire process of procurement, acceptance, storage, sales, transportation, after-sales service, etc., and keeps relevant records to ensure that business conditions and business activities continue to meet the requirements.
- At the same time, medical device business enterprises should establish a quality management self-inspection system, , conduct self-inspection in accordance with the requirements of the quality management specifications for medical device business, and submit the self-inspection report of the previous year to the department responsible for drug supervision and management at the municipal and county levels before March 31 each year.
pays more attention to quality management in the entire operation process:
- requires medical device operators to purchase medical devices from medical device registrants, filings, and operating companies with legal qualifications, strictly control the qualification review of procurement and sales links, and ensure the legal circulation of medical devices.
- highlights the recording requirements for purchase inspection and sales, ensures the traceability of products, and shall implement the unique identification system of medical devices in accordance with relevant national regulations.
- emphasizes the storage and transportation requirements for low-temperature and refrigerated medical devices to ensure product transportation quality, and further emphasizes the full-process traceability management.
Pure Jun New Materials is committed to providing comprehensive solutions for cold chain transportation, independently developing a number of high-performance cold chain temperature control transportation boxes in the field of medical cold chain. Combining low-latency high-speed communication technologies such as cloud platforms, Internet of Things, databases, etc., it realizes long-term passive precise temperature control, and provides one-stop solution for precise temperature control + real-time monitoring of cold chain transportation. helps enterprises achieve real cost reduction and efficiency improvement.
The 4.0 new passive temperature-controlled box independently developed by the company, realizes accurate temperature-controlled transportation of drugs from the main line to the branch line without the need for a cold chain vehicle or plug-in. The box is light and the time ranges from three days to dozens of days. In response to a variety of scenarios and needs, it provides customized, efficient and energy-saving cold chain packaging services for pharmaceutical and third-party logistics companies. has made a breakthrough in temperature-controlled phase change technology for mRNA at -70 ℃, and launched a new crown vaccine box in China.
Pure Jun New Materials, as a high-tech enterprise integrating production, sales and research, has also established a professional production base to provide quality assurance!
