Release date: 2016-01-26
Flight inspection has gradually played an important role in investigating problems, controlling risks, and deterring illegal activities in all aspects of drug development, production, management, and use. The flight inspections around medical device companies have also been continuously upgraded, and R&D units, Production companies, sales companies and clinical institutions have put forward higher requirements to further escort the entire process of medical devices.
Flying inspection accelerates medical equipment shuffling
In December 2014, the State Food and Drug Administration issued the “Announcement on the Implementation of Quality Management Regulations for Medical Device Management†(No. 58 of 2014); on June 29, 2015, it further announced the “Measures for the Inspection of Drugs and Medical Devices†( The State Food and Drug Administration, Order No. 14) requires that from September 1, 2015, strengthen the management of medical devices, standardize the operation and management of medical devices, strengthen daily supervision, and ensure the safety of public equipment.
The "Measures for the Inspection of Drugs for Medical Devices" consists of five chapters and 35 rules. It is clearly stated in the general rules that the medical device flight inspection refers to the supervision and inspection of the food and drug supervision and management department for the development, production, operation and use of drugs and medical devices without prior notice. “Although production and operation are the core of the enterprise, the new regulations clearly require the development and use of medical institutions, including the use of medical institutions and medical device registration.†A medical and drug safety supervisor of a food and drug regulatory department If so.
Hu Changming, chief of the inspection department of Guangdong Medical Device Quality Supervision and Inspection Institute, further stated that the supervision of the pharmaceutical industry is getting stronger and stronger. For example, the labeling problem was rarely punished during the sampling process, but now according to the new version of the 6th order. The Medical Device Manual and Label Management Regulations require that the label will face penalties if it does not meet the requirements. “Quality management practices have rarely been heard in the past that companies have been punished or ordered to suspend production because of system failures. However, the new regulations now have stricter and more specific regulations on quality management systems, and there are very detailed penalties. The requirements for the company's quality system are becoming more stringent."
Since the launch of the flight inspection in 2006, after more than 9 years, pharmaceutical production and operation companies have entered the normal period of large-scale flight inspection. In the month of implementation of the “Measures for the Inspection of Drugs and Medical Devicesâ€, CFDA conducted a flight inspection of a number of medical device companies, and two of them in Guangdong received a notice of rectification that ordered the suspension of production. In the recent “GSP Risk Management Training Course for Medical Devices under the New Situation of Flight Inspection†held in Zhuhai and Shenzhen, the deputy director of the Pharmaceutical Affairs Management Committee of Guangdong Pharmaceutical Association and the general manager of Guangzhou Guojian Pharmaceutical Consulting Service Co., Ltd. The release and implementation of a series of policies will prompt medical device companies to enter the daily supervision mode of flight inspection. "It is foreseeable that flight inspection will become a regular regulatory measure for the medical device industry, and the fierce market competition for the deeper survival of the fittest in medical device companies will kick off."
Medical equipment GSP needs to be standardized
The seven ways to initiate the flight inspection of pharmaceutical medical devices include: complaints report or other sources of clues indicating that there may be quality and safety risks; inspections found that there are quality and safety risks; adverse drug reactions or medical device adverse events monitoring may indicate quality and safety risks There are doubts about the authenticity of the application materials; suspected of serious violations of the requirements of quality management regulations; enterprises have serious records of non-trustworthiness; other situations requiring flight inspection.
In November 2015, the website of the Guangdong Food and Drug Administration issued the “Notice on the Flight Inspection of Medical Device Enterprises in 2015â€, which was registered as a registered agent and after-sales service organization for high-risk imported medical device products in the province . A total of 60 operating companies are involved. Focus on checking whether the qualifications of the operating enterprises meet the requirements; whether the quality management system is strictly enforced; whether the purchase and sales channels are standardized and the records are complete; whether the transportation and storage of low-temperature and cold-storage facilities are required, whether the cold chain transportation and storage conditions are complete, storage and transportation Whether the record is true and complete. As a result, 20 companies found different levels of problems, and gave disposal measures such as suspension of business, rectification and cancellation.
Obviously, medical device management is an important part of flight inspection. The “ Standard for the Implementation of Acceptance of Medical Device Business Enterprises in Guangdong Province†revised in 2012, the Regulations on the Supervision and Administration of Medical Devices issued in March 2014 (No. 650 of the State Council), and the Supervision and Management of Medical Device Management promulgated in July 2014 The Measures, the “Quality Management Standards for Medical Device Management†issued in December 2014, and the “Guidelines for On-site Inspection of Medical Device Management Quality Management Regulations†promulgated in October 2015, all of which propose that medical device companies must follow Operating quality management practices to implement.
The review of the registration department and the regulatory authorities has been tightening. Any Yuhui, the head of the GSP research office of Guojian Medical Consulting, pointed out: "In terms of the authenticity of the application materials, GSP certification materials were provided when the pharmaceutical companies applied for the products, and the provincial bureaus accepted them. It is necessary to arrange a certification inspection, but before the certification inspection, due to the suspicion that the application information provided by the enterprise may be fraudulent, the company first conducted a surprise flight inspection of the enterprise. I think that medical equipment will certainly have a similar situation in the future, which also gives medical treatment. Equipment companies have sounded the alarm. In addition, companies must be careful not to violate the requirements of quality management regulations, especially the careful selection of medical device suppliers. If the supplier has problems, it will also affect the company."
Source: Pharmaceutical Economics
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