Apply for medical device business license

Aaron Peng from Hong Kong Xintong said that applying for a Class II medical device license in Shenzhen requires a large amount of relevant information and many procedures for approval.，Then we need to consult relevant people to integrate the information when applying.，Among them, the relevant contents regarding medical device application include the following points:：(1) The person in charge of quality should have a college degree or above in medical equipment or related majors or a relevant recognized professional and technical title (relevant majors refer to machinery，electronic，medical，pharmaceutical，Bioengineering，Chemical industry，care，computer Science，project，agriculture，medicine and medicine，Same below)。

The person in charge of quality should be familiar with the regulations on the supervision and management of medical devices，Relevant knowledge of regulations and operation of medical devices，Have some practical experience。In vitro diagnostic reagent operating companies，The person in charge of quality should have a bachelor's degree or above and a related major (laboratory，Microbiology，medicine，Pharmacy，Biochemistry, etc.，The same below) Intermediate and above professional titles，Be familiar with relevant laws and regulations，And have more than 5 years of relevant work experience in in vitro diagnostic reagents。

1. The person in charge of the quality management agency shall have a bachelor's degree or above in medical device or related majors or a relevant recognized intermediate technical title or above in the relevant majors.，Have more than 2 years of medical device related work experience。In vitro diagnostic reagent operating companies，The person in charge of the quality management organization should have a bachelor's degree or above and related majors (laboratory，Microbiology，medicine，Pharmacy，Biochemistry and other majors。

) Intermediate and above professional titles，Be familiar with relevant laws and regulations，Have more than 5 years of working experience in in vitro diagnostic reagents；

1. The person in charge of quality and the person in charge of the enterprise quality management organization are on duty，Not allowed to work part-time in other units，No record of serious violations of medical device regulations。
2. The person in charge of quality and the person in charge of the quality management organization should receive on-the-job training，You can take up the job only after passing the exam。
3. A person who exceeds the relevant statutory retirement age is the person in charge of the enterprise's quality management organization，His or her age must not exceed 68 years of age，And provide a physical examination certificate issued by a second-level or above medical institution in Shenzhen。
4. Applying for product implantation business，It should also be equipped with a medical undergraduate degree or above，and trained by the manufacturer or supplier，Two people working，Not allowed to work part-time in other units。

Those who exceed the relevant statutory retirement age and do not exceed 65 years old，Provide a physical examination certificate issued by a second-level or above medical institution in Shenzhen。The person in charge of the enterprise or the quality management personnel shall not concurrently serve as the medical technicians referred to in this article.。Based on the above six points, we can know that when applying for a medical device license，A very large amount of information needs to be prepared。

When applying, you still need to go through multiple approval processes.，Therefore, when an enterprise needs documents related to medical device qualifications, it can consult Hong Kong Xintong International for processing.，Hong Kong Xintong International has thirteen years of business service experience in Shenzhen，There are many successful cases for medical device related qualification applications.。Familiar with the industrial and commercial process for medical device qualification application，Prepare clear preliminary information。Merchants in need please consult Hong Kong Xintong International as soon as possible。

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