Want to enter the medical device industry? It is crucial to understand the qualification requirements first! Medical device business implementation of "classification supervision", different categories corresponding to the filing / licensing requirements are very different, wrong not only can not operate normally, but also may face the risk of fines.

Today for you to clearly disassemble a class, class II, class III medical device classification standards and the required qualifications, and then detailed description of class II filing, class III license conditions, the novice can easily read and understand! Finally attached is a program to help you save the heart on behalf of the program, to help you take 90% less detours ~!

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01.First divided into categories: 3 classes of medical devices, qualification requirements vary widely

Medical devices are classified into three categories according to the degree of risk. The higher the risk, the stricter the regulation and the higher the corresponding qualification requirements, and the core differences are as follows:

• Class I Medical DevicesLow risk, no need for licensing and filing, as long as there is a legal business license and the scope of business includes the corresponding categories, you can operate directly. Common categories such as medical masks (general grade), medical swabs, thermometers and so on.
• Class II medical devices: Moderate risk, requiring processingClass II medical device business record certificateThe company is not allowed to carry out business activities until it gets the record. Common categories such as medical protective clothing, blood glucose meters, ultrasound diagnostic equipment.
• Class III medical devices: High level of risk, most stringent regulation, need to obtain firstClass III Medical Device Licenseand the filing needs to be completed without one. Common categories such as pacemakers, artificial joints, and vascular stents.

Important reminder: unauthorized operation without obtaining the corresponding qualification is an illegal act, punishable by a maximum fine of 100,000 yuan or more than 500,000 yuan, and will also be confiscated the illegal operation of medical devices and illegal income!

There are all kinds of qualification licenses, import and export record, import and export tax rebate, Beijing company registration, Shanghai company registration, Guangzhou company registration, Shenzhen company registration, Hong Kong company registration, the United States company registration, the United Kingdom company registration, Singapore company registration, Vietnam company registration, Malaysia company registration, Thailand company registration, e-commerce tax compliance, difficult write-offs and other issues areYou can scan the code to add our online customer service (cell phone WeChat the same number: 16625410105), to arrange for the manager to answer questions, provide professional advice and full one-on-one service!

02. Core dismantling: conditions for Class II filing / Class III licenses

Many entrepreneurs are stuck in the "processing conditions do not meet the standard", such as the site does not meet the requirements, the lack of professional staff. The following is the core conditions of the two types of filing and three types of licenses are disassembled one by one, compared with the self-check is clearer:

✅ Class II medical device business filing: 4 core conditions must be met

1. Main requirements: must be a limited liability company, individual households can not be handled (this is a mandatory requirement, individual households want to do the second type of business need to upgrade the company);
2. Business Scope: The business scope of the company's business license must clearly include "sales of Class II medical devices";
3. Site requirements: the business premises and warehouse must be an independent space, not residential (apartments will not do), and the area can not be less than 30 square meters, need to be equipped with basic storage equipment (such as shelves, temperature and humidity meter, etc.);
4. Personnel requirements: at least 1 college degree and above, medical-related professionals, while there must be a test supervisor and a laboratory technician (need to provide proof of education, qualifications)

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✅ Class III Medical Device License: 5 Key Conditions + Special Requirements

The requirements for Class III licenses are more stringent, and in addition to the basic conditions, there are additional requirements for some categories:

1. Site requirements: must be office space, the use of the area of at least 45 square meters; if the operation of the key regulatory medical devices (such as in vitro diagnostic reagents, implantable devices), the area requirements are higher (usually not less than 60 square meters);
2. Personnel Requirements: Core personnel need to meet the standard - at least 3 relevant professionals, including the head of the company, the person in charge of quality, quality inspectors, and all 3 need to complete the filing and hold the corresponding practitioner's qualification certificate;
3. Product Requirements: The medical devices to be operated must be within the business scope, and the legal certificates of the products (such as product registration certificates, production licenses, etc.) must be provided to ensure product compliance;
4. Subject requirements: again, must be a limited liability company, individual households can not apply;
5. Special requirements: If the business scope includes "in vitro diagnostic reagents", it also needs to be equipped with a special cold storage (temperature control at 2-8 ℃), and establish a perfect cold chain management system.
   

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03.Qualification is too cumbersome? The whole process to help you easily

Many entrepreneurs feedback: for qualification, they not only have to check the conditions repeatedly, but also have to prepare a large number of materials and run multiple departments, which is time-consuming and labor-intensive; in the case of incompatible venues and lack of professionals, it is even more difficult to advance in the case of a jam.

To address these pain points, we are launchingFull range of servicesWe will help you to solve all the problems from the preparation of materials, review of conditions to the filing/permit processing, and follow up the whole process:

• Full-range agency: no need to run departments by yourself, dedicated docking regulators, efficiently promote the process, shorten the time to get the license;
• Provision of personnel: To solve the pain point of "lack of medical-related professionals", we provide personnel who meet the requirements of the record and qualification certificates;
• Provide address: Provide an independent business premises/warehouse that meets the regulatory requirements and fulfills the hard conditions such as area and nature, without the need to find an address on your own.

Whether you want to do Class I, Class II or Class III medical device business, whether you are a startup or need to upgrade your qualification, you can dock the appropriate solution!

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Summarize: qualification compliance is a prerequisite for business, choose the right way to take less detours

The core threshold of the medical device industry is "qualification compliance", first distinguish which category you want to operate, and then prepare against the conditions, in order to step on the pit. If you feel that the process is cumbersome and the conditions are difficult to meet the standards, it is a more efficient choice to find a professional team to do the job for you.

There are all kinds of qualification licenses, import and export record, import and export tax rebate, Beijing company registration, Shanghai company registration, Guangzhou company registration, Shenzhen company registration, Hong Kong company registration, the United States company registration, the United Kingdom company registration, Singapore company registration, Vietnam company registration, Malaysia company registration, Thailand company registration, e-commerce tax compliance, difficult write-offs and other issues areYou can scan the code to add our online customer service (cell phone WeChat the same number: 16625410105), to arrange for the manager to answer questions, provide professional advice and full one-on-one service!