Port communicationThe upcoming 2020 Shenzhen International Medical Instrument Exhibition has attracted a large number of medical device industry companies to sign up to participate.，SoShenzhen enterprise handlingMedical device business licenseHow long does it take?
Medical device business license application
one、How long does it take to apply for a Shenzhen medical device business license??
handleMedical device business licenseThe time required for the process：According to the "Measures for the Supervision and Administration of Medical Device Operations", there are clear provisions：
1、It will take up to 5 working days to inform you whether it is accepted or not.；
2、It will take up to 30 working days for review after acceptance；
3、It will take up to 10 working days to issue the certificate if you are qualified.。
Different processing categories，The length of time is also different。Operating Class I medical devices does not require licensing or registration，The operation of Class II medical devices shall be subject to registration management，License management is implemented for operating Class III medical devices。
Apply for a medical device business license in Shenzhen，There are no problems in materials and on-site verificationWithin 45 working days under normal circumstanceswill be done。
Engage in the research and development of medical devices in Shenzhen in accordance with the "Regulations on the Supervision and Administration of Medical Devices"、Production、business、Usage activities and their supervision and management，Medical device license should be applied for。
Class II medical device registration is issued on the same day，Class III medical device business license conditions will be issued 15 working days after submission of the conditions for review。
Medical device business license application time
two、To apply for medical device business registration or business license in Shenzhen, the following conditions must be met:：
1、quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management，College degree or above or intermediate technical title or above in related majors。(Require：Must have a college degree or above in medical device major and more than 3 years of experience，2more than one person)；
2、Have operations that are commensurate with the business scope and scale of the business、storage place；(The usable area of the business premises should be no less than 40 square meters，The usable area of the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);
Dealer of hearing aids，The usable area of the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions，The usable area of the business premises should not be less than 10 square meters)；
3、Have storage conditions suitable for the business scope and scale，If all storage is entrusted to other medical device operating enterprises, there is no need to set up a warehouse.；(Require：Business facilities and equipment must be consistent with business products and business methods, as well as laws and regulations)；
4、Have a quality management system suitable for the medical devices it operates；(Require：The operation and management system must be consistent with the operation methods and products and laws and regulations)；
5、Have professional guidance appropriate to the medical devices being operated、Technical training and after-sales service capabilities。
Shenzhen Medical Device License
three、Class II medical device filing requirements：
1、Class II medical device registration application form
2、Business license or pre-certification notice
3、legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate
4、Business premises、Geographical location map of warehouse address、floor plan、Copy of property ownership certificate or lease agreement (with property ownership certificate attached)
5、Product certificate
6、Home purchase and sale contract、Purchase channels
Special reminder：Class II medical device registration is valid for 5 years，6 months before expiryGo to your local districted municipal food and drug supervision and administration department，Renewal of new registration certificate for Class II medical devices。
In summary：If the preparation time and rectification time are not included, the government review time alone will take 45 working days, or 2 and a half months.。
If the preparation time, rectification and re-audit time after rectification are calculated, it will be longer.，If technical ability is insufficient、Lack of thorough understanding of laws and regulations、Insufficient information preparation、The combination of factors such as incomplete rectification will greatly extend the period or even lead to failure of approval for up to one year.。The most common thing that happens is that companies still don’t know where the problem lies after failing the audit.，Or I don’t know how to rectify it, so I have gone through a lot of mistakes.，It consumes a lot of manpower, material resources and time costs。
Notice：If there is a problem or rejection in any of the above steps, all previous work will need to be started from scratch.，Therefore, attention should be paid to doing the best in every aspect。Therefore, you should be extra careful when applying，If you choose an agency, you should choose one with strong technical capabilities.52Agency network。
