One, get the necessary business qualifications
Opening a medical device store first requires obtaining the appropriate business qualifications. This usually involves applying for a Medical Device Business License from the local Food and Drug Administration. The application process requires basic information about the business, proof of identity of the legal representative, quality management system documents and other relevant materials.
Two, ensure suitable business premises
The business premises of a medical device store needs to comply with the relevant regulations, including the area, layout, environment and other requirements. The premises should be clean, bright and have proper storage conditions to ensure safe and effective storage of medical devices.
Three, configure the necessary equipment and facilities
Medical equipment stores need to be configured with the scale of operation of the equipment and facilities, including medical equipment display cabinets, storage cabinets, refrigeration equipment. In addition, it also needs to be equipped with the necessary testing instruments and tools for quality testing and acceptance of medical devices.
Four, the establishment of a sound quality management system
Medical device stores must establish and strictly implement a quality management system to ensure that all aspects of procurement, acceptance, storage, sales and after-sales service are in line with the requirements of laws and regulations. This includes the development and implementation of medical device acceptance standards, storage specifications, sales records and so on.
V. Compliance with laws and regulations and industry standards
Opening a medical device store must comply with relevant national and local laws and regulations, as well as medical device industry standards. This includes the classification and management of medical devices, advertising, price management and other aspects of the regulations.
In summary:
Opening a medical device store requires obtaining the appropriate business qualifications, securing suitable business premises and configuring the necessary equipment and facilities, as well as establishing a sound quality management system and complying with relevant laws, regulations and industry standards. Only on the basis of meeting these conditions can a medical device store be operated legally, safely and effectively.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article VIII provides:
The opening of the second class, the third class of medical equipment business enterprises shall be subject to the review and approval of the food and drug supervision and management department of the people's government of the province, autonomous region and province-level municipality directly under the Central Government, and issued a "medical equipment business license"; without a "medical equipment business license", the Administration for industry and commerce shall not issue a business license.
"Supervision and Administration of Medical Devices Regulations"
Article 19 provides:
Medical device business enterprises shall, in accordance with the requirements of the quality management standard for medical device business, establish a quality management system covering the whole process of business management, and make good records, to ensure that the operating conditions and business practices continue to meet the requirements.