At present, the overall level of medical equipment in China's medical equipment is still very low. It is 10 to 20 years behind some developed countries. The medical device industry is a multidisciplinary, knowledge-intensive, and capital-intensive high-tech industry with a high entry threshold. The sales of medical devices produced in China are rare in some developed countries.
Through the investigation of the American market by the Marketing Department of the Milo Group Company and local laws and regulations, the Milo Group 's products must first be FDA certified if they want to enter the US market. The United States has over one hundred years of history in medical device supervision. The regulatory agency, the US Food and Drug Administration, has also developed from a chemical office of the United States Department of Agriculture in 1862 to become an important food, medicine, and medical device regulatory agency in the world. Since the United States first regulated the management of medical devices, its established classification management method has been universally accepted. Therefore, the laws and models for administering medical devices in the United States have a great influence on the world.
After the above understanding and analysis, Min Luo Group Company decided in January 2011 that the top management decided that the company's portable dental treatment machine should carry out FDA certification; in March the company invited FDA certified experts to guide the company and learn 510K. Registration process and product requirements. By learning portable dental machines in the U.S. medical device management category, it is necessary to register 510K in 1 category.
After FDA certification experts trained the Qualcomm certifiers, they learned a lot of knowledge. In May, the company installed a portable dental treatment machine according to the FDA certification requirements and sent it to the Guangdong Medical Device Testing Institute for testing. Passed more than a month, the product successfully passed the test, and made a test report.
In July, the information was mailed to the FDA auditor for review. After more than 80 days of audit, it was found that the products of the Minmetals Group Company had a Bacterial Test Report with three gun nozzles and asked for replenishment. The company immediately contacted the Guangdong Provincial Medical Device. The test was linked to the detection of bacteria in the three-gun nozzle and an English report was issued. The inspection was completed in November and the inspection report was mailed to the FDA for approval. After more than 130 days of verification, it passed the audit and registered at 510K in December.
The FDA certificate not only plays a key role in the development of the U.S. market, but also greatly promotes the market in other countries. Some FDA certificates are an essential document for the import of medical devices in the United States, and customs inspections are more stringent. This has brought credibility and visibility to the Miluo Group and our country. And to increase the sales of Minmetals Group !
Through the investigation of the American market by the Marketing Department of the Milo Group Company and local laws and regulations, the Milo Group 's products must first be FDA certified if they want to enter the US market. The United States has over one hundred years of history in medical device supervision. The regulatory agency, the US Food and Drug Administration, has also developed from a chemical office of the United States Department of Agriculture in 1862 to become an important food, medicine, and medical device regulatory agency in the world. Since the United States first regulated the management of medical devices, its established classification management method has been universally accepted. Therefore, the laws and models for administering medical devices in the United States have a great influence on the world.
After the above understanding and analysis, Min Luo Group Company decided in January 2011 that the top management decided that the company's portable dental treatment machine should carry out FDA certification; in March the company invited FDA certified experts to guide the company and learn 510K. Registration process and product requirements. By learning portable dental machines in the U.S. medical device management category, it is necessary to register 510K in 1 category.
After FDA certification experts trained the Qualcomm certifiers, they learned a lot of knowledge. In May, the company installed a portable dental treatment machine according to the FDA certification requirements and sent it to the Guangdong Medical Device Testing Institute for testing. Passed more than a month, the product successfully passed the test, and made a test report.
In July, the information was mailed to the FDA auditor for review. After more than 80 days of audit, it was found that the products of the Minmetals Group Company had a Bacterial Test Report with three gun nozzles and asked for replenishment. The company immediately contacted the Guangdong Provincial Medical Device. The test was linked to the detection of bacteria in the three-gun nozzle and an English report was issued. The inspection was completed in November and the inspection report was mailed to the FDA for approval. After more than 130 days of verification, it passed the audit and registered at 510K in December.
The FDA certificate not only plays a key role in the development of the U.S. market, but also greatly promotes the market in other countries. Some FDA certificates are an essential document for the import of medical devices in the United States, and customs inspections are more stringent. This has brought credibility and visibility to the Miluo Group and our country. And to increase the sales of Minmetals Group !
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