Please ask the second class of medical equipment record certificate where can I do?
"Supervision and Administration of Medical Devices" Article XII engaged in the operation of Class II medical devices, the business enterprise shall be the location of the municipal food and drug supervision and management department for the record, fill in the Class II medical device business filing form, and submit the information provided for in Article 8 of these measures (except for the eighth item). Article 13 of the food and drug supervision and management department shall be on the spot on the integrity of the information submitted by the enterprise to check, in line with the provisions of the record to be filed, issued by the second class of medical equipment business filing vouchers. So it is recommended that the city council online guide to understand, and then do the appropriate information to go to the city council's medical device section for the second class filing voucher work.
What are the requirements for filing a Class II medical device?
Should have with the scale and scope of operation of the business premises and storage conditions.
Engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Ordinance, that is, to engage in the operation of medical devices, there should be with the scale of operation and the scope of operation of the business premises and storage conditions, as well as with the operation of the medical device quality management system and quality management institutions or personnel. Management system and quality management organizations or personnel.
Medical equipment business enterprises, the use of units to purchase medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system.
Engaged in the second and third class of medical devices wholesale business and the third class of medical devices retail business enterprises, should also establish a sales record system.
The validity of the record of Class II medical devices?
The filing of Class II medical devices is not valid, mainly depends on your business license, if the business license has Class II medical devices, the company also operates Class II medical devices, you must apply for Class II medical device filing, if the business license, the company does not operate, there is no need to apply for the business time for the business can be done, do not operate, do not worry about it, the Class III medical device license is valid, five years to change the certificate once. validity period, five years for a certificate, the expiration date can not operate three types of medical equipment, even if the business license has three types of business scope, business license expired is also unable to operate.
How many days do I need to review the filing certificate for Class II devices?
About the Office of Class II medical device license filing takes 1-2 days working days, complete information, the legal representative, the person in charge of the enterprise's basic information and qualifications, the administrative department for industry and commerce issued by the Office of the pre-approval of the enterprise name notification, as well as the production of enterprises in charge of the quality of the technical resumes, academic or professional title certificates, relevant professional and technical personnel, workers Registration form, indicating the departments and positions, senior, intermediate and junior technical staff of the proportion of the situation, the production site documents and other relevant information
Apply for Class II medical device business record of the notes?
1, the legal representative of the enterprise, the person in charge of the enterprise, quality management personnel should not be "supervision and management of medical devices regulations" Article 40 of the situation.
2, the enterprise should have with the scale and scope of operation of the quality management organization or full-time quality management personnel.
3, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
4, should be in accordance with relevant national and local regulations, the establishment of a sound and necessary quality management system, and strictly enforced.
5, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.