What qualifications are required to operate a Class III medical device? The latest requirements to share

What qualifications are needed to operate Class III medical devices? The latest requirements to share

What are the application conditions for the license to operate Class III medical devices? What is the filing information delivery of Class III Medical Device Operation License?In 2022, new regulations in the medical device industry come out frequently, how to apply for the latest "Medical Device Operation License"? Here is a professional CIO compliance assurance organization to guide.

A customer case

1, Foshan City, Di Mai Trade Co., Ltd. wants to engage in the operation of the third class of medical devices, in order to faster obtain the "Medical Device License", Di Mai Trade entrusted CIO compliance assurance organization to counsel the whole process.

2. Guangdong Tongwei Pharmaceutical Co., Ltd. intends to apply for the renewal of medical device license before the expiration date, and entrusted CIO Compliance Assurance Organization to provide medical device license renewal project consulting and guidance, according to its actual situation, for its proposed hardware conditions, technical staffing, quality management system consulting services.

Second, the application conditions and processes

1, to apply for three types of medical equipment business license, there must be a relevant business license, the general business license on the business scope of the column, you need to clearly write that you can sell three types of medical equipment. If not, you need to go to the Trade and Industry Bureau for additions.

2, the sale of Class III medical devices, you must have their own warehouse, and the warehouse needs to be set up in the cold storage, because the Class III medical devices, there is a need for insulation, more than a certain temperature, it is easy to deteriorate and affect the quality of the product, so very few dealers have the qualifications to sell Class III medical devices.

3, go to the Trade and Industry Bureau for additions, is required to bring the Trade and Industry Bureau staff to view the warehouse, you better clean up the warehouse, and then get the "Medical Device Business License Application Form" and fill out the form, and all the relevant qualifications of the enterprise to bring, but also need to bring the quality of the relevant information of the staff.

4, three types of medical equipment business license, you need to go directly to the municipal drug supervision and management department for, in the acceptance of information within 30 days after the audit, if in line with the relevant provisions, you can issue three types of medical equipment business license.

CIO Compliance Assurance Organization provides medical device business license processing business, coaching enterprises to pass the on-site inspection at one time, and successfully get the license.

Third, in the application, you have encountered the following problems?

1, change the business name, registered address, warehouse address, unauthorized reduction of warehouse area, or even cancel the warehouse?

2, no training records, quality management system has not been revised in a timely manner or strictly enforced, individual enterprise warehouse management chaos, product storage conditions to varying degrees of reduction, the product is not in accordance with the requirements of the sub-regional storage, not equipped with or use of temperature and humidity control and monitoring equipment, or not to take short-term early warning?

3, the warehouse computer system can not be connected to the office computer system in real time and *** enjoy the data?

4, how to collect legal qualification certificates and product quality information?

CIO compliance assurance organization to provide medical device license issuance for business, coaching enterprises to pass the on-site inspection at once, and successfully get the certificate.

Fourth, the reasons for choosing CIO Compliance Assurance Organization

1, CIO Compliance Assurance Organization was founded in 2003, there are 18 years of industry experience precipitation, 2000 more than 2,000 two, three types of medical device project success experience.

2, CIO Compliance Assurance Organization has a team of more than 100 experts, in-depth understanding of the medical device life cycle of each link, to help customers take the initiative to avoid risk, shorten the cycle of obtaining the certificate.

3, CIO compliance assurance organization has its own server to protect customer data security, dedicated to protect customer information from leakage.

4, CIO compliance to ensure that all aspects of the organization to ensure smooth service.