The dental implanted giant was discontinued and rectified, and the "Flying Inspection" of the State Drug Administration again issued prestige

After a lapse of one year, the State Drug Administration once again sacrificed the "big killer" of flight inspection.

On July 20, the State Drug Administration issued a notice of flight inspection. After investigation, the Sichuan Bye Meng Biological Activation Materials Co., Ltd. had problems in terms of equipment operation, procurement and production management. At present, the Sichuan Bye Alliance has discontinued production and rectification, and it can only be recovered after being represented by the Sichuan Pharmaceutical Supervision Bureau.

Established in 1993, Sichuan Bya Meng held 100%of the Sichuan University Technology Industry Group Co., Ltd., a subsidiary of Sichuan University. What is the reason why this company's name is not famous, and the State Drug Administration suddenly conducts strict flight inspections. What is the reason?

Bayemon is actually a manufacturer of dental and orthopedic consumables. The most famous product is dental implants. Baya Meng's implants are known as one of the top ten brands in China. The price of 3,000 yuan per online is a domestic dental implanted mid -range product.

Since the heated discussion of "one -to -one houses" during the two sessions in 2021, the wind of dental implants has been blowing for more than a year. Sichuan is the leader of the dental implants collection of dental implants, but the purchasing volume has been reported twice, and the collection is not launched.

More than a year after a lapse of the State Drug Administration, suddenly the flying inspection of a domestic dental implants enterprise, and imposed a punishment for the suspension of business and rectification.

Related products may be recalled

The State Drug Administration believes that there are three main problems in Sichuan Bai Amon:

In terms of institutional personnel and factory facilities, Sichuan Bye Meng's procedures and institutional documents in two production sites in Chengdu are not consistent. There are two versions. One of the production sites is not even from Sichuan Baya Meng himself. Personnel, production and equipment on the venue belong to another related company.

The production of medical devices should also abide by the GMP specifications, and the production address needs to be approved. The reform of the system of medical devices has not been fully rolled out. In any case, worship of Amon's approach has seriously violated relevant regulations.

In terms of procurement, Sichuan Bye Meng did not sign the quality agreement with the supplier of the product raw material; in terms of product production, the company failed to provide relevant sterilization confirmation reports, which did not meet the "Management of the Quality Management of Medical Device Production". Requirements of the bacterial process confirmation ".

The implant of dental implants should be implanted in the human body. If it is not completely sterilized, it will bring serious harm to the human body. Obviously it was seriously violated.

The State Drug Administration believes that Sichuan Bai Amon violated the documents such as the "Management of Quality Management of Medical Devices" and other documents, and the quality management system "had serious defects." The company shall timely evaluate product safety risks and recall related products that may lead to hidden safety hazards in accordance with regulations. At present, Sichuan Bye Meng has acknowledged that the company does have the above problems and follow the request to suspend production.

The State Drug Administration has not announced what products are involved in Bai Amon.

Sichuan is a major province of dental implants in China. In April 2019, Ziyang City, Sichuan Province, announced that it will build a "International Oral Equipment Material Base" in the next three years to create a world -renowned "China Tooth Valley" and form an output value of more than 30 billion yuan by 2025. This is this value. A action plan was supported by the Sichuan Provincial Party Committee.

Therefore, the state gave the heavy task of dental implants to Sichuan lead organization. But at present, Sichuan's progress is slow.

The strong support for the dental consumable industry quickly attracted the attention of the country.

Dental implants are transformed?

In November 2021, the Sichuan Provincial Pharmaceutical Recruitment Service Center carried out information application for implants, repairing base platforms and its accessories. In March 2022, Sichuan announced that according to national requirements, it took the lead in procurement of provincial intervals in the provinces in 30 provinces.

Although it is "inter -provincial", 30 provinces have basically covered the entire China. This news is regarded as a signal of formal landing of dental implants.

In the domestic market, foreign brands such as Oga Thai, Dengteng, and Shizhuman "rampant". The domestic dental implants industry manufacturing is still relatively late, and the market awareness and recognition of domestic products are not high. Zhang Lei, chief physician of Peking University Stomatology Hospital, introduced on the popular popularization platform that there are only more than 10 domestic brands that are currently approved for listing.

Bye Meng is a representative variety of domestic products. This domestic planting system was jointly developed by Sichuan University and West China Medical University. It was a "domestic implant work" and began to be clinical in the 1990s.

Therefore, the Flying Inspection Office of the Pharmaceutical Supervision Bureau has a strong demonstration meaning.

The dental implants organized by Sichuan may not be developed smoothly. In April 2022, Sichuan Province announced that under some "application of manufacturers", the Provincial Recruitment Center decided to start a second report. But before that, this happened whether it was inter -provincial or national collection. The number of secondary reports is most likely because some companies have not participated in the first report.

To dental implants, we need to solve many problems. Because of the expensive planting, the reason is not only expensive, but also expensive. The Jianzhi Bureau had previously estimated that the planting material cost of planting a teeth only accounted for about 30%of the total cost. Light pairs of implants can not be completely fired.

However, the "one teeth of 10,000 yuan" on the market can only save the people a few hundred dollars after the collection. This result will definitely not be explained to public opinion. This is the difficulty of dental implants.

So far, Sichuan Province has not disclosed the list of corporates participating in the two reports. As for why related companies actively apply for participation in the report, the outside world may not know.The Jianzhi Bureau noticed that after the second report in April, Sichuan never disclosed information about dental implants.### National Medicine Supervision Bureau ## Sichuan worship Amon#

- END -