A company registration and qualification requirements
First of all, to open a medical device company needs to register the company and obtain a legal business license. At the same time, according to relevant laws and regulations, medical device companies also need to obtain the appropriate medical device business license. These documents are the basis for carrying out medical device business activities.
Two, personnel qualification requirements
Medical device companies need to have the appropriate personnel qualifications. The person in charge of the company and key positions need to have medical device-related professional knowledge and experience, and after training and qualification. In addition, the company needs to have a certain number of professional and technical personnel, responsible for product quality control and technical support.
Three, business premises and equipment and facilities
Medical device companies need to have business premises and equipment and facilities that meet the requirements. Business premises should meet the requirements of health, safety and other aspects of the equipment and facilities should meet the product production, storage, transportation and other needs. At the same time, the company also needs to establish a perfect warehouse management system to ensure the quality and safety of products.
Four, quality management system requirements
Medical device companies need to establish and implement quality management system to ensure product quality and safety. This includes the development of product quality standards and inspection methods, the establishment of product traceability systems, product quality monitoring and evaluation. Effective implementation of a quality management system is an important measure to protect public health and safety.
In summary:
Opening a medical device company needs to meet a series of conditions, including company registration, personnel qualifications, business premises, equipment and facilities, quality management system and other requirements. The fulfillment of these conditions is the basis for ensuring that a medical device company operates in compliance and protects public health and safety.
Legal basis:
Regulations on the Supervision and Administration of Medical Devices
Article 4 states:
The state implements classified management of medical devices in accordance with the degree of risk. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices to implement record management, the operation of Class III medical devices to implement licensing management. Medical device license is valid for 5 years, the license number, enterprise name, legal representative, responsible person, residence, business premises, mode of operation, business scope, warehouse address, the licensing department, the date of issuance and expiration date of validity and other matters.
"Supervision and Administration of Medical Devices Regulations"
Article 26 states:
Medical device business enterprises, the use of units shall not operate, use not registered in accordance with the law, no documents of conformity, as well as expired, expired, eliminated medical devices.