Shenzhen Medical Device Business License Application Conditions

The conditions for handling medical devices in Shenzhen are actually roughly the same., It’s just that some districts have slightly different information., Not a big problem, The overall processing conditions for Category 2 are relatively simple., Mainly three categories, In the third category, it is necessary to see which products the company mainly operates, It is also different from the attributes of the warehouse whether it needs to be refrigerated or constant temperature., If you operate a wide variety of bulldozers, You need to find a suitable agency that knows how to handle it to help you complete it., Not only can it save time but also improve business efficiency, To learn more about the conditions for processing medical devices in Shenzhen, please contact 52 Daiban.

Apply for registration Category II, Key nodes in the process of Class III medical devices: 1.Prepare information for application: Through the Guangdong Provincial Government Service Network, Search the name of the approval item "Medical Device Registration Approval", Select "Issuance of Class II Medical Device Registration Certificate". Fill in the application information online, and upload relevant electronic documents.

2.Acceptance of materials submitted on site: The handling agency will determine whether to accept the application within 5 working days from the date it receives the online application materials., Conduct credit information inquiries on administrative counterparts and implement joint rewards and punishments. Application materials are incomplete or do not comply with legal forms, Notify the applicant of all the necessary supplements and corrections within five days, Failure to notify after the due date, The application will be accepted from the date of receipt of the application materials..

3.Waiting to get the processing result: Applicants can log in to the approval inquiry column on the home page of the Guangdong Provincial Food and Drug Administration’s public website to check the progress of the application., Or log in to the online service platform to check the progress. Electronic certificates have been implemented for this matter, No additional paper certificates will be issued, Applicants can apply for certification themselves, You can also go to the provincial bureau acceptance hall with your digital certificate to print the certificate yourself..

Apply for registration Category II, Information that should be prepared before using Class III medical devices: 1.Prepare the registered company 2. Office address

Require

: (Lease the original copy - Office, The actual usable area is more than 80㎡, Recommend about 120㎡), floor plan, storehouse: The actual usable area is more than 40 square meters 3. Legal representative, supervisor, Copy of shareholder’s identity and USB shield 4. Legal representative, Business person in charge, Quality manager (resume) with correct identity, Educational qualifications or professional titles are correct, Original copy of the physical examination 5. Professional and technical personnel (quality managers), Acceptance personnel, computer maintenance, Warehouse personnel, repair, After-sales service) Identity is correct, Clear academic qualifications (medical device related majors) 6. Medical device special system software 52 Daiban assists agents

Application process

time flow: Sign a service contract → Prepare application materials → Submit to the competent government unit for review → Pass the preliminary review → Make an appointment for on-site review by a dedicated official → Re-examine if the review is passed → Obtain the certificate of medical device Class II after passing the re-examination, Application time for three categories respectively: Class II medical device registration can be completed within one day after receiving the information..

The application for Class III medical devices can be completed within 40 working days after receiving the information..

52The agency network has been focusing on agency applications for medical device licenses in Guangdong Province for nine years., Contains Class II medical devices, Class III medical device license application, Add items, Change and cancel business, Rich window service experience, Familiar with various industries and commerce

Process

, From consultation, Additional conditions, Prepare materials for review, Issuance of qualifications, 52 Daiban always adheres to the one-stop service concept, 52 Daiban’s mature handling model, is the service industry price

Advantages

key, Welcome further communication.

Our services for business owners in the medical industry 1. Medical device business license (including in vitro diagnostic reagents) renewal We provide domestic in vitro diagnostic reagent business, Circulation and trading companies provide a full range of, One-stop medical device business license renewal service. 2.New application for medical devices (including in vitro diagnostic reagents) and changes to enterprises engaged in third-category operations, Assist operating enterprises to apply to the local municipal food and drug supervision and administration department.

3.Class II medical device registration and cancellation of enterprises engaged in Class II operations, Assist operating enterprises to apply for registration with the local municipal food and drug supervision and administration department. 4.The first registration service of the third-party platform for medical device online transaction services 5. Based on the innovation needs of enterprises across the entire industry chain, Provide personalized consultation and services. Validity period of the medical device business license: 1. The "Medical Device Business License" is valid for 5 years..

Validity expires, Need to continue operating medical device products, Medical device operating enterprises shall notify the company 6 months before the expiration date, The drug regulatory authority applies for renewal of the "Medical Device Business Enterprise License". 2.The (food) and drug regulatory authorities shall review the application for replacement in accordance with the provisions of these Measures..

3.The (food) and drug regulatory authorities deem it consistent with

Require

of, A new license should be issued when the "Medical Device Business Enterprise License" expires., Withdraw the original "Medical Device Business Enterprise License"; 4.Not eligible, Corrections should be made within a time limit, Those who still do not meet the conditions after rectification, The original "Medical Device Business Enterprise License" should be canceled when the validity period expires., Notify the applicant in writing and explain the reasons, At the same time, the applicant is informed that he or she has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law..

The Measures for the Supervision and Administration of Medical Devices, "Measures for the Supervision and Administration of Medical Device Operations," were reviewed and adopted at the executive meeting of the State Food and Drug Administration on June 27, 2014., Now announced, Effective from October 1, 2014.

Remark: According to the "Regulations on the Supervision and Administration of Medical Devices", Enterprises that have not obtained compliance operation qualifications, May be fined not more than RMB 100,000 by the competent authority, Or a fine of not less than 10 times but not more than 20 times the value of the goods may be imposed; Serious circumstances, 5Applications for medical device licenses submitted by relevant responsible persons and enterprises will not be accepted during the year..