Access threshold to improve the number of medical equipment companies in Hainan
On the afternoon of January 21, Hainan Provincial Food and Drug Administration held the first meeting of the province's medical device supervision work, and announced the interpretation of the “Inspection and Acceptance Standards for Medical Device Enterprises in Hainan Province†(hereinafter referred to as “Standardsâ€) to the medical device enterprises in the province. Strengthen the supervision of the medical device market. Hainan medical equipment market is a bit messy “The employees in Hainan medical equipment market are chaotic and have poor quality awareness. As long as they have some funds and contacts, they can enter this industry.†This is the head of a company in Hainan who has been engaged in the medical device industry for 12 years. "According to industry predictions, the next 10 to 15 years will be the 'golden period' of China's rapid development of the medical device industry, but in the face of development opportunities, the medical device situation in Hainan Province faces many challenges." Hainan Food and Drug Administration Deputy Director Wang Lizhen said that medical devices and medicines have the same quality problems, but they are often ignored. According to reports, Hainan's medical device industry currently has the following "broken legs": First, most of the existing medical device manufacturing and operation enterprises in Hainan are small in scale, low in management level, and insufficient in risk prevention and control. Second, some medical device production and management companies have a sense of responsibility, quality awareness, law-abiding awareness and a weak sense of integrity, which has aggravated the hidden dangers of medical device safety risks. Third, due to the lack of supervisors in Hainan, long-term heavy approval and light supervision, resulting in some confusion in the current market, the market entry threshold is low. "It is extremely urgent to protect the safety of the people and promote the healthy development of the medical device industry and strengthen supervision." Wang Lizhen said. Remediation of Hainan's non-standard medical device market "With the arrival of the international tourist island, Hainan will build a world-class tourist destination and put more stringent requirements on the safety of people's machinery." Wang Lizhen said that Hainan's current medical device market is chaotic, and the original medical device business enterprise inspection and acceptance standards The demand is not high, and the market entry threshold is too low is an important reason. To this end, in 2009 Hainan for the first time large-scale medical equipment special rectification. During the rectification, it was found that illegally reducing production and operation conditions and changing the address of the registered address warehouse and other illegal and illegal activities were prominent in some medical device production and management enterprises, and became the target of special rectification work. According to regulations, the production and operation of medical devices must hold relevant licenses as well as drugs. At present, a total of 37 production enterprises and 370 operating enterprises in the province have been included in the scope of rectification. Through rectification actions, 11 enterprises have applied for cancellation of licenses through self-inspection, 27 enterprises have been announced to cancel, and 55 enterprises have been required to rectify. And handle the license change procedures. The new "standard" to improve the access threshold of Hainan medical equipment market According to Wu Chengjie, Director of the Medical Devices Division of the Provincial Food and Drug Administration, the new Standards implemented on January 1, 2010 have undergone new changes. First, the qualifications of quality managers and quality management agencies have been improved. The second is to increase the area of ​​business premises. If the enterprise operates medical equipment below 4 categories (including), the business area of ​​Haikou and Sanya shall not be less than 120 square meters, and the operating area of ​​other areas shall not be less than 100 square meters; for operation of 5 categories or above, Haikou, The area of ​​business premises in Sanya shall not be less than 150 square meters, and the operating area of ​​other areas shall not be less than 120 square meters. There are new requirements for the warehouse area. Products that require shady and refrigerated storage must also be equipped with corresponding cool storage and cold storage facilities. In addition, strict requirements have been added to the management system and quality. It is reported that the new "Guidelines for Inspection and Acceptance of Medical Device Business Enterprises in Hainan Province" was implemented in January 2010. The Provincial Food and Drug Administration requested that enterprises newly applied for after January 1, 2010 be inspected and accepted according to the new standards; 2010 1 Medical device wholesale enterprises that have obtained the "Medical Device Business Enterprise License" before the 1st of the month must take the initiative to rectify the requirements according to the new standards. They will pass the inspection and acceptance before July 1, 2010. Those who fail to pass the acceptance will be punished. The specific inspection and acceptance time of the enterprise is from February 1st to May 30th, and June 1st to June 30th is the final rectification time of the enterprise. From July 1st, all enterprises will start to implement the new standard. Each business enterprise shall submit the application acceptance materials in advance according to the time schedule. What is Bioresonance Therapy Machine?
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