Class II medical device registration certificate application agency services
Domestic medical device registration agency company, CIO compliance assurance organization to provide you with one-stop consulting agency services, CIO has been to help medical device manufacturers on behalf of the certificate of registration, production licenses, GMP certification and other services to help enterprises fast, worry-free to get the certificate. If you have this business needs, you can contact us.Reasons for choosing CIO Compliance Assurance Organization:
Experienced: The company was founded in 2003, has 18 years of industry experience precipitation, 2000 more than 2,000 Class II and Class III medical device project success experience Professional quality: Our more than a hundred people team of experts, in-depth understanding of the whole life cycle of the various aspects of the medical device, to help customers 1. Application through the Guangdong Provincial Government Services Network, search for approval matters name "medical device registration approval", select "Class II medical device registration certificate issued". Fill out the application online, and upload the relevant electronic documents. 2. Acceptance processing authority to receive the online application materials within five working days from the date of acceptance to determine whether the administrative counterparts to credit information queries and the implementation of joint awards and penalties. Application materials are incomplete or do not meet the statutory form, within five days of the applicant to inform the need to correct all the contents of a single, late notification, from the date of receipt of the application materials shall be accepted. 3. Get results Applicants can log on to the Guangdong Provincial Food and Drug Administration public network home page for approval of the inquiry column for progress inquiries, or log on to the online platform to check the progress. This matter has been the implementation of electronic certificates, no longer separately issued paper certificates, the applicant can play their own certificate, digital certificates to the provincial bureau of acceptance of self-service printing certificates.Application for Class II medical device license to have the basic conditions:
1, the enterprise should have with the scale and scope of quality management institutions or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles, is recognized by the qualification of professional and technical personnel. 2, with the scale and scope of independent business premises, storage conditions. 3, with the management of the product technical training, after-sales service capabilities. 4, the establishment of a sound quality management system, and strictly to implement. In addition, the application for a medical device license housing requirements, must be office buildings, commercial purposes, can not be civil, residential and so on. And need to provide the office area of the floor plan, the warehouse should be clean, ventilated, good light.Two types of medical equipment company registration/application for a license required materials:
1, business license original copy; 2, legal representative ID card front and back copy; 3, the person in charge of the enterprise ID card front and back copy, a copy of the diploma; 4, the official seal; 5, the operating Proof of site.Two types of medical equipment business filed on behalf of the process:
1, submit the medical equipment business filing application information, the Food and Drug Administration on the information on the form of review; 2, the Food and Drug Administration on-site to see the site; 3, through the form of review; 4, to get the filing of the notice, the record can be found online information.