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Has anyone tried to wholesale and distribute medical device consumables online? Is it reliable?

Has anyone tried to wholesale and ship medical device consumables online? Is it reliable?

Our company has been there before. I heard from the buyer that they are all licensed products. Who has used the medical device consumables platform? How was it?

I think it’s okay, but it mainly depends on your own needs. No matter how much I tell you, you may not believe it. Just go to the platform and see for yourself. How to register for the medical device consumables platform? Urgent!

Don’t worry, go to the official website first, or download the app, and then find the registration interface. If it is the computer web version, you can click "Register for Free" first. Registration is very simple and does not require filling in a lot of information. Can medical devices be sold online?

To sell medical devices online, the following conditions must be met:

1. Obtain a drug and medical device sales license issued by the national food and drug administration authority. ;

2. Obtain an online sales license for drugs and medical devices issued by the Ministry of Information Industry.

In other words, online sales of medical devices must be subject to dual supervision by the food and drug administration authorities and the network administration authorities. What are the platforms for medical device consumables? Which one should I choose?

Check a lot online. But to be honest, a lot of them aren’t great, they’re just ads. Personally, I prefer the medical device consumables platform, where you can purchase goods and read news, and there are no advertisements.

Can household medical devices be purchased online?

Interim Provisions on the Approval of Internet Drug Transaction Services

Article 1 is to strengthen drug supervision and management and regulate Internet drug transactions. According to the "Drug Administration Law of the People's Republic of China" and " These regulations are formulated in accordance with the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other relevant laws and regulations.

Article 2: Those engaged in Internet drug trading service activities within the territory of the People's Republic of China must abide by these regulations.

The term “Internet drug trading services” as mentioned in these regulations refers to e-commerce activities that provide trading services for drugs (including medical devices, packaging materials and containers in direct contact with drugs) through the Internet.

Article 3 Internet drug trading services include services provided for Internet drug transactions between drug manufacturers, drug operating companies and medical institutions. Drug manufacturers and drug wholesale companies communicate with their members through their own websites. Internet drug transactions conducted by other enterprises and Internet drug transaction services provided to individual consumers.

The term "members of an enterprise" as mentioned in these regulations refers to enterprise group members or enterprise legal persons that have full equity or controlling rights in drug manufacturers or drug wholesale enterprises that provide Internet drug trading services.

Article 4 Enterprises engaged in Internet drug trading services must undergo review and acceptance and obtain an Internet drug trading service agency qualification certificate.

The acceptance standards for Internet drug trading service institutions are uniformly formulated by the State Food and Drug Administration (see Appendix 1). The qualification certificate for Internet drug trading service institutions is uniformly printed by the State Food and Drug Administration and is valid for five years.

Article 5: The State Food and Drug Administration shall examine and approve enterprises that provide services for Internet drug transactions between drug manufacturers, drug operating companies and medical institutions.

The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall regulate drug manufacturers, drug wholesalers, and individuals that conduct Internet drug transactions through their own websites with other companies other than members of the company within their own administrative regions. Enterprises that provide Internet drug trading services to consumers are subject to review and approval.

Article 6 Enterprises that provide services for Internet drug transactions between drug manufacturers, drug operating companies and medical institutions shall meet the following conditions:

(1) Established in accordance with the law Enterprise legal person;

(2) The website that provides Internet drug trading services has obtained the qualification to engage in Internet drug information services;

(3) It has places and facilities suitable for conducting business , equipment, and have the ability to self-manage and maintain;

(4) Have sound network and transaction security measures and a complete management system;

(5) Have complete preservation The ability, facilities and equipment to record transactions;

(6) Have transaction service functions such as online inquiries, order generation, electronic contracts, and online payments;

(7) Have the ability to ensure online transactions Complete management systems, equipment and technical measures to ensure the legality and authenticity of data and information;

(8) Have computer professional technicians to ensure the normal operation and daily maintenance of the network, and have sound internal management of the enterprise Institutions and technical support agencies;

(9) An review department composed of full-time professionals with a bachelor's degree in pharmacy or related majors and familiar with laws and regulations related to drugs and medical devices is responsible for the review of online transactions.

Article 7: Interconnection between drug manufacturing enterprises, drug operating enterprises and medical institutions

Enterprises that provide services for online drug transactions shall not participate in drug production and operation; shall not interact with administrative agencies , medical institutions and drug production and operation enterprises have affiliations, property rights and other economic interests.

Article 8 Drug manufacturers and drug wholesale enterprises that conduct Internet drug transactions with other companies other than members of the company through their own websites shall meet the following conditions:

(1) Provide Internet drug trading service websites have obtained the qualification to engage in Internet drug information services;

(2) Have venues, facilities, and equipment suitable for business operations, and have the ability to self-manage and maintain;

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(3) Have a sound management organization, with network and transaction security measures and a complete management system;

(4) Have facilities and equipment to completely preserve transaction records;

(5) Have basic transaction service functions such as online inquiries, order generation, and electronic contracts;

(6) Have a complete management system to ensure the legality and authenticity of online transaction materials and information , facilities, equipment and technical measures.

Article 9 Enterprises that provide Internet drug trading services to individual consumers must meet the following conditions:

(1) A drug chain retail enterprise established in accordance with the law;

< p> (2) The website that provides Internet drug trading services has obtained the qualification to engage in Internet drug information services;

(3) It has sound network and transaction security measures and a complete management system;

(4) Have the ability, facilities and equipment to completely save transaction records;

(5) Have basic transaction service functions such as online consultation, online inquiry, order generation, and electronic contract;

(6) Have complete management systems and measures for the varieties traded online;

(7) Have a drug distribution system that is suitable for the varieties traded online;

(8) Have a licensed pharmacist responsible for online real-time consultation, and have facilities, equipment and related management systems to store complete consultation content;

(9) Those engaged in medical device trading services should be equipped with medical device-related professional qualifications , Full-time professionals who are familiar with regulations related to medical devices.

Article 10 Enterprises that apply to engage in Internet drug trading services should fill in the "Application Form for Engaging in Internet Drug Trading Services" (Annex 2) issued by the State Food and Drug Administration and submit it to the province or autonomous region where they are located. , apply to the municipal (food) drug regulatory department and submit the following materials:

(1) A copy of the license for the website that intends to provide Internet drug trading services to engage in Internet drug information services;

(2) Business development plan and related technical solutions;

(3) Management measures to ensure that trading users and trading drugs are legal, authentic and safe;

(4) Copy of business license;

(5) Management systems and measures to ensure network and transaction security;

(6) Copies of identity certificates and academic certificates of specified professional and technical personnel and Resume;

(7) Summary list of instruments and equipment;

(8) Description of the basic business process to be carried out and related materials;

(9) Legal requirements of the enterprise Documents proving the representative and a functional list of the organizational structure of each department of the enterprise.

Article 11: After receiving the application materials, the (food) drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government shall conduct a formal review of the application materials within 5 days. If it decides to accept the application, it shall issue an acceptance notice; if it decides not to accept the application, it shall notify the applicant in writing and explain the reasons, and at the same time inform the applicant of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

Article 12 If the application materials are irregular or incomplete, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall notify the applicant once within 5 days from the date of receipt of the application materials that supplements and corrections are required. All contents; if no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials.

Article 13 The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall, within 10 working days after accepting applications for providing Internet drug trading services to drug manufacturers, drug operating companies, and medical institutions. Submit relevant application materials to the State Food and Drug Administration.

The State Food and Drug Administration will review the application materials in accordance with relevant regulations, and make a decision within 20 working days to agree or disagree for on-site acceptance, and notify the applicant in writing, with a copy of the acceptance letter The (food) drug regulatory department of the applying province, autonomous region, or municipality directly under the Central Government.

If the State Food and Drug Administration agrees to conduct on-site acceptance, it shall organize on-site acceptance of the applicant according to the acceptance standards within 20 working days.

If the acceptance fails, the applicant shall be notified in writing and the reasons shall be explained. At the same time, the applicant shall be notified of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law; if the acceptance is qualified, the State Food and Drug Administration shall issue a verification certificate to the applicant within 10 working days. Serve the qualification certificate of the Internet drug trading service institution that agrees to engage in Internet drug trading services.

Article 14 The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with relevant regulations, regulate drug manufacturers and drug manufacturers that provide Internet drug transaction services through their own websites with other companies other than members of the company. Materials submitted by wholesale enterprises and applicants who provide Internet drug trading services to individual consumers will be reviewed and approved, and a decision will be made within 20 working days to agree or disagree with on-site acceptance, and the applicant will be notified in writing.

If the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government agrees to conduct on-site inspection and acceptance, it shall organize on-site inspection and acceptance of the applicant within 20 working days. If the product fails to pass the acceptance inspection, the applicant shall be notified in writing and the reasons shall be explained. At the same time, the applicant shall be informed of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law; if the product passes the inspection and acceptance, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall conduct the inspection in 10 Within working days, the applicant will be issued and served an Internet Drug Trading Service Institution Qualification Certificate that agrees to engage in Internet drug trading services.

Article 15: When the State Food and Drug Administration and the (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government review the applicant’s application, they find that the administrative licensing matters are directly related to the significant interests of others. , the interested party shall be notified, and the statements and defenses of the applicant and the interested party shall be heard. If a hearing is required according to law, a hearing shall be held in accordance with legal provisions.

Article 16 If false materials are provided to apply for Internet drug trading services, the (food) drug regulatory department will not accept the application and will give a warning. The enterprise's application for Internet drug trading services will not be accepted within one year. .

For those who provide false materials to apply for engaging in Internet drug trading services and obtain an Internet drug trading service agency qualification certificate, the (food) drug regulatory department shall revoke their Internet drug trading service agency qualification certificate and not accept their application for Internet drug trading services within three years. Application for Internet drug transaction services.

Article 17 After obtaining the qualification certificate for Internet drug trading service institution issued by the (food) and drug regulatory department in accordance with the law, the applicant shall obtain the corresponding qualification certificate in accordance with the provisions of the "Internet Information Services Management Measures" Telecommunications business license, or perform corresponding filing procedures.

Article 18: Enterprises that provide Internet drug trading services must indicate the Internet drug trading service organization qualification certificate number in a prominent position on the homepage of their website.

Article 19: Enterprises that provide Internet drug trading services must strictly review the qualifications of drug manufacturers, drug operating companies, and medical institutions participating in Internet drug transactions to engage in drug transactions and the legality of the drugs traded.

For drug manufacturers, drug operating companies, medical institutions and drugs that are trading online for the first time, companies that provide Internet drug trading services must obtain and review the qualification certification documents and drug approval certification documents of all parties to the transaction and conduct Filing.

Article 20: Drug manufacturers and drug wholesale companies that conduct Internet drug transactions with other companies other than members of the company through their own websites can only trade drugs produced by the company or operated by the company, and are not allowed to use Its own website provides other Internet drug trading services.

Article 21: Enterprises that provide Internet drug trading services to individual consumers can only sell over-the-counter drugs operated by the enterprise online, and are not allowed to sell drugs to other enterprises or medical institutions.

Article 22: Drug manufacturers, drug trading companies and medical institutions that conduct drug transactions on the Internet must go through Internet drug transactions that have been reviewed and approved by the (food) and drug regulatory authorities and the telecommunications business authorities. Service companies conduct transactions. Medical institutions participating in Internet drug transactions can only purchase drugs and are not allowed to sell drugs online.

Article 23 If an enterprise that provides Internet drug trading services changes its website address, company name, company legal representative, company address, etc., it should fill in the "Internet Drug Trading Service Change Application Form" (see Attachment 3), and apply for change procedures to the original approval department 30 working days in advance. The change procedures are the same as the original application procedures. If the service scope is changed, the original qualification certificate will be withdrawn and re-applied in accordance with these regulations for re-approval.

Article 24 If an enterprise that provides Internet drug trading services needs to cease operations for more than six months, it should submit a request to the (food) drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government one month before it ceases services. Written filing application. After receiving the filing application, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall notify the telecommunications management department within 10 working days.

During the validity period of the Internet Drug Trading Service Organization Qualification Certificate, if a closed or suspended enterprise needs to resume operations, it shall apply to the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it has registered for re-acceptance. Business can be resumed only after passing the inspection.

Article 25 If the validity period of the Internet drug trading service agency qualification certificate expires and it is necessary to continue to provide Internet drug trading services, the enterprise providing Internet drug trading services shall submit a request to the original issuer within 6 months before the expiration of the validity period. The licensing authority applies for renewal of the Internet Drug Trading Service Organization Qualification Certificate.

Article 26 The original certificate-issuing authority shall review the certificate renewal application in accordance with the original application procedures. If it is deemed that the conditions are met, a new certificate shall be issued; if it is deemed that the conditions are not met, the certificate shall not be renewed. The notice shall state the reasons, and the original Internet Drug Trading Service Organization Qualification Certificate shall be withdrawn by the original issuing authority and announced for cancellation.

The original license-issuing authority shall make a decision on whether to approve the renewal of the Internet Drug Trading Service Organization’s qualification certificate before the expiration of the validity period. If no decision is made within the time limit, the replacement of the certificate shall be deemed to be approved, and the original certificate-issuing authority shall complete the reissue procedures within 30 working days.

Article 27 Based on the written application of the enterprise that provides Internet drug trading services, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government may withdraw the qualification certificate of the Internet drug trading service agency and report it to the National Food and Drug Administration The Supervision and Administration Bureau shall register and announce the cancellation. If the qualification certificate of an Internet drug trading service institution is withdrawn, it shall not continue to engage in Internet drug trading services.

Article 28 If an Internet drug trading service organization engages in Internet drug trading services without obtaining the qualification certificate, or the Internet drug trading service organization qualification certificate exceeds the validity period, the (food) drug regulatory department shall order it to make corrections within a time limit. , give a warning; if the circumstances are serious, they will be handed over to the information industry department and other relevant departments for punishment in accordance with relevant laws and regulations.

Article 29 If an enterprise providing Internet drug trading services has any of the following circumstances, the (food) drug regulatory department shall order it to make corrections within a time limit and give a warning; if the circumstances are serious, its Internet drug trading services shall be revoked Institutional qualifications, and cancel its Internet Drug Trading Service Organization Qualification Certificate:

(1) Failure to indicate the Internet Drug Trading Service Organization Qualification Certificate number in a prominent position on its website homepage;

(2) Providing Internet drug trading services beyond the scope of review and approval;

(3) Providing Internet drug trading services for the interconnection between drug manufacturers, drug operating companies and medical institutions

The service enterprises have affiliations, property rights or other economic interests with administrative agencies, medical institutions and pharmaceutical production and operation enterprises;

(4) Relevant changes have not been approved.

Article 30 If an enterprise that provides Internet drug trading services provides services for unauthorized enterprises or institutions to trade unapproved drugs, the (food) and drug regulatory authorities shall impose penalties in accordance with relevant laws and regulations. Revoke its qualification as an Internet drug trading service organization and cancel its qualification certificate as an Internet drug trading service organization. At the same time, it will be handed over to the information industry department and other relevant departments for punishment in accordance with relevant laws and regulations.

Article 31 If an enterprise that provides services for Internet drug transactions between drug manufacturers, drug operating companies and medical institutions directly participates in drug operations, the (food) drug regulatory department shall comply with the provisions of the People's Republic of China *** and Article 73 of the Drug Administration Law of the People's Republic of China will impose penalties, revoke its qualifications as an Internet drug trading service agency, cancel its qualification certificate as an Internet drug trading service agency, and hand it over to the information industry authorities and other relevant departments in accordance with relevant laws and regulations. The regulations provide for penalties.

Article 32 If a drug chain retail enterprise that provides Internet drug trading services to individual consumers sells prescription drugs online or sells drugs to other companies or medical institutions, the (food) drug regulatory department shall, in accordance with the drug Administrative laws and regulations will impose penalties, revoke its Internet drug trading service agency qualifications, and cancel its Internet drug trading service agency qualification certificate. At the same time, it will be handed over to the information industry department and other relevant departments for punishment in accordance with relevant laws and regulations.

Article 33 If drug manufacturers, drug operating companies and medical institutions conduct Internet drug transactions through Internet drug trading service companies that have not been approved or are beyond the scope of approval, the (food) drug supervision and administration The department ordered corrections and gave warnings.

Article 34 (Food) Drug Supervision and Administration Department has violated Articles 72, 73, and 7 of the "Administrative Licensing Law of the People's Republic of China" during the review and approval of Internet drug trading services. In the circumstances specified in 14 and 77, it shall be handled in accordance with relevant regulations.

Article 35 (Food) and Drug Supervision and Administration Departments shall supervise and inspect websites that provide Internet drug trading services, and announce the inspection results to the public.

Article 36: The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government may formulate specific review requirements and procedural regulations in accordance with these regulations, and submit them to the State Food and Drug Administration for filing.

How to search for medical devices online

Formal medical devices are sales channels that require registration before they can be put on the market. For ordinary consumers, pharmacies and hospitals are more reliable, but there is also the risk of buying fake and shoddy medical devices. There are product registration numbers and production license numbers on the product. Make a note of these two and check on the website of the State Food and Drug Administration or the upgraded Food and Drug Administration of the province where the product is produced to check whether the qualification has expired, etc.

Another Buying medical devices online is very risky and there are a lot of fakes. It is recommended not to try it or contact the manufacturer directly to buy medical devices. Is it reliable?

Is it reliable if it is a regular medical device sold to hospitals? , if it is a health care device sold to an individual, it is difficult to say. Is Aozida's medical device consultation reliable?

I think it’s better to leave it to the CRO company to do a better job! Clinical trials are complicated! Can medical devices be bought and sold online?

Online transactions are not very mature for medical devices. In addition, considering that customers can actually get the products they need, they should use the Internet as a platform to understand the products in detail and consult and communicate with the manufacturers. , it’s better to make a choice again. You can go to safe. to see if there is a product you want.