1. Medical device agency requirements:
1. Documentation requirements for operating medical devices: application form for medical device business license in quadruplicate, copy of applicant's qualification certificate, and notice of pre-approval of medical device business name.
2. Personnel requirements: the person in charge of the medical device enterprise should have a college degree or above and be familiar with the relevant laws and regulations of medical devices. At the same time, the person in charge of the enterprise, quality management personnel and quality inspection personnel cannot hold other positions concurrently. Quality management personnel must have a college degree or above and more than one year's work experience.
3. Requirements for office space and warehouse: The office space of medical device enterprises is required to be a non-residential area. The reagent use area is not less than 60 square meters. The warehouse requires that the non-residential living area should not be less than 20 square meters, and some products should be more than 100 square meters. It also requires facilities and equipment such as light, ventilation, dustproof, insect-proof, moisture-proof, rat-proof, pollution-proof, fire safety, detection and temperature and humidity adjustment, and lighting facilities to meet the requirements. Storage shall be managed by division and classification, clearly marked and stored according to product batches. The reservoir area should be divided into waiting area, qualified product area, delivery area, unqualified product area and other special places.
4. Requirements of health management system and after-sales service system: Enterprises engaged in medical devices should establish a sound health management system to ensure the safety of products. In addition, the enterprise should have the technical training and after-sales service ability suitable for the medical device products it operates or agree to provide technical support by a third party.
2. Will the country of medical devices make inspection compulsory?
According to China's "Regulations on the Management of Medical Devices", medical devices need to be inspected before leaving the factory, and this inspection is mandatory, and only qualified products can be used.
legal ground
Regulations on the supervision and administration of medical devices
Article 84 Under any of the following circumstances, the pharmaceutical supervisory and administrative department shall announce the name of the unit and product to the public and order it to make corrections within a time limit; If no correction is made within the time limit, the illegal income and medical devices illegally produced and operated shall be confiscated; If the value of medical devices illegally produced and operated is less than 6,543.8+0,000 yuan, a fine of 6,543.8+0,000 yuan and 50,000 yuan shall be imposed; If the value of the goods is more than 6,543.8+0,000 yuan, a fine of more than 5 times and less than 20 times the value of the goods shall be imposed; If the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated, and a fine of more than 30% and less than 2 times of the income of the unit during the illegal act shall be imposed, and it shall be prohibited to engage in the production and business activities of medical devices within five years:
(1) Producing and operating Class I medical devices without filing;
(two) engaged in the production of Class I medical devices without filing;
(three) the operation of second-class medical devices should be filed but not filed;
(four) the information that has been filed does not meet the requirements.