On January 19th, the State Food and Drug Administration (CFDA) issued the official website of the " Medical Device Management Quality Management Regulations" (GSP, hereinafter referred to as "Specifications") through the official website. After a long period of drafting, revision, and solicitation of opinions, finally Formally landed, more than 180,000 medical device operators across the country have ushered in a strict management era, and the big waves will be an era of industry reshuffle.
CFDA issued a message saying: In order to strengthen the quality management of medical device management, standardize the operation and management of medical devices, and ensure the safety and effectiveness of public medical equipment, according to the newly issued Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Management, CFDA The "Quality Management Regulations for Medical Device Management". It was reviewed and approved by the 16th meeting of the CFDA in 2014, and was announced on December 12, and will be implemented as of the date of promulgation.
The "Specifications" consists of nine chapters and sixty-six articles, requiring medical device operating enterprises to establish and improve quality management systems in accordance with the "Regulations", and adopt effective quality control measures in the aspects of medical equipment procurement, acceptance, storage, sales, transportation, and after-sales services. Guarantee the quality and safety in the business process.
In order to fully implement the "normative" work, combined with the release of the "Regulations", CFDA will also accelerate the capacity building of medical device supervision and inspectors, improve the ability and level of supervisors, lay a good foundation for the implementation of the "Specifications", and further improve medical care. The quality assurance level of equipment management enterprises.
Five cases may not have an independent medical equipment warehouse
This seems to be quite different from the GSP certification of the drug, which proves that the General Administration has taken care of the special situation of the equipment industry, and the certification is not a one-size-fits-all. This will bring benefits to many operating companies, not only reduce the cost of certification construction and renovation, but also does not have the operating and management costs of the warehouse.
(1) The display conditions of the business premises of a single store retail enterprise can meet the performance requirements of the medical device products it operates, and the business premises can meet the needs of its business scale and variety display;
(2) Chain retail operations of medical devices;
(3) All medical equipment operating enterprises that are entrusted to provide storage and distribution services for other medical device production and operation enterprises to store;
(4) franchise medical equipment software or large-scale medical equipment such as medical magnetic resonance, medical X-ray, medical high-energy radiation, medical nuclear equipment;
(5) Other circumstances as stipulated by the provincial food and drug supervision and administration department may not establish a medical equipment warehouse separately.
How long will the certification last?
The pharmaceutical industry started GSP certification in 2002-2003, and this year, the local government continues to promote the new GSP certification.
However, it is reported that the pharmaceutical industry will not engage in GSP certification and GMP certification. What is going on here?
In November 2014, the author asked for a deputy inspector from a CFDA department, and combined the relevant information, as follows:
The future GSP certificate and business qualification certificate "two certificates in one", in response to the national call, reduce the administrative examination and approval authority, but the GSP requires a lot of matters, standards, in order to meet the GSP standards beforehand, can get the business qualification certificate, And usually will increase the number of flight inspection operations, the requirements can be said to be more stringent.
The author analyzes that the country's experience in the pharmaceutical industry will certainly use medical device management in the future, including GMP, GSP, and the current provincial-level consumables bidding.
In general, the process of standardization is the process of continuous improvement of concentration, the process of continuous reshuffle of the industry, the death or the survival, all based on the strategy, ideas and strategies of the enterprise.
Innovative jet embedded nylon technology maximizes the efficiency of sample collection from patients. Nylon adheres vertically and evenly to the surface of the swab tip, improving the efficiency of cell and liquid sample collection and release. Increased analytical sensitivity, no specimen residue, and accelerated specimen processing.
Flocked Swab,Collect swabs from specimens with flocked tips,Medical sampling swab oral nylon swab flocking,Acts in the clinical diagnosis
Jiangsu iiLO Biotechnology Co., Ltd. , https://www.sjiilobiotech.com