Who has used the medical device supplies platform?
I think it's okay, but I think it's a good idea.
I think it's okay, but it depends on your needs. I said more you do not necessarily believe, they go to the platform to see it. The first thing you need to do is to get your hands dirty!
Don't worry, first enter the official website, or download the app, go to find the registration interface. If it is a computer web version, you can first click "free registration". The first thing you need to do is to get your hands on a new product, and you'll be able to get it to work.
In other words, online sales of medical devices, to be subject to both the food and drug regulatory authorities and network regulatory authorities double supervision.
Medical device consumables platform? What are the platforms? Which one to choose
There are a lot of them online. But seriously, a lot of them are not good, they are advertisements. Personally, I prefer the medical device supplies platform, I can buy goods and read the news, but there is not much advertising.
Home medical equipment can be bought online?
Interim Provisions for the Approval of Internet Drug Trading Services
Article 1 In order to strengthen the supervision and management of drugs, standardize the Internet drug trading, according to the "People's Republic of China **** and the State Drug Administration Law", "People's Republic of China **** and the State Drug Administration Law Enforcement Regulations" and other relevant laws and regulations, the formulation of these provisions.
Article 2 In the People's Republic of China *** and the State engaged in Internet drug trading service activities, must comply with these provisions.
The Internet drug trading services referred to in these provisions, refers to the provision of pharmaceuticals through the Internet (including medical devices, packaging materials and containers in direct contact with pharmaceuticals) trading services of e-commerce activities.
Article 3 of the Internet drug trading services, including drug manufacturers, drug companies and medical institutions to provide services between the Internet drug transactions, drug manufacturers, drug wholesalers through their own Web site and the members of the enterprise other than the Internet drug transactions and Internet drug trading services provided to individual consumers.
The provisions of this enterprise members, refers to members of the enterprise group or to provide Internet drug trading services of drug manufacturers, drug wholesalers have all the equity or controlling interest in the enterprise legal person.
Article IV engaged in Internet drug trading services must be reviewed and acceptance of enterprises and obtain the Internet drug trading services qualification certificate.
The acceptance criteria for Internet drug trading services by the State Food and Drug Administration unified development (see Annex 1). Internet drug trading services qualification certificate printed by the State Food and Drug Administration, valid for five years.
Article V of the State Food and Drug Administration for drug manufacturers, drug companies and medical institutions to provide services between the Internet drug transactions for approval.
Provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration for the administrative region through its own Web site and the enterprise members other than the Internet drug trading drug manufacturers, drug wholesalers and individual consumers to provide Internet drug trading services for approval.
Article 6 Enterprises providing services for Internet drug transactions between drug manufacturers, drug wholesalers and medical institutions shall have the following conditions:
(1) an enterprise legal person established in accordance with the law;
(2) a web site providing Internet drug transaction services that has obtained the qualification of engaging in Internet drug information services;
(3) a web site that possesses (C) has the premises, facilities and equipment suitable for carrying out business, and has the ability of self-management and maintenance;
(D) has a sound network and transaction security measures and a complete management system;
(E) has the ability to keep complete transaction records, facilities and equipment;
(F) has the ability to query online, generating orders, electronic contracts, online payment and other transaction services;
(F) has the online query, generating orders, electronic contracts, online payment and other Transaction service functions;
(VII) to ensure the legitimacy of online transaction data and information, authenticity of the perfect management system, equipment and technical measures;
(VIII) to ensure the normal operation of the network and the daily maintenance of computer professionals and technicians, with a sound internal management and technical support organizations;
(IX) with a bachelor's degree in pharmacy or related disciplines, familiar with drugs, drugs, drugs, and drugs, and drugs and technology. (ix) with a bachelor's degree in pharmacy or related disciplines, familiar with the drugs, medical devices and related laws and regulations of the full-time professionals responsible for the review of the online transaction review department.
Article VII for drug manufacturers, drug companies and medical institutions to provide services for the interconnection between
Internet drug trading enterprises shall not be involved in the production and operation of drugs; shall not be with the administrative organs, medical institutions and drug production and management enterprises have affiliation, property rights and other economic interests.
Article VIII through its own Web site and the enterprise members other than the Internet drug transactions of pharmaceutical manufacturers and pharmaceutical wholesalers should have the following conditions:
(a) to provide Internet drug trading services, the site has been qualified to engage in Internet drug information services;
(b) with the development of the business of the appropriate premises, facilities, (B) has a suitable place to carry out business, facilities, equipment, and have the ability to self-management and maintenance;
(C) has a sound management organization, with network and transaction security measures as well as a complete management system;
(D) has a complete preservation of the transaction records of the facilities, equipment;
(E) with online query, generation of orders, electronic contracts, and other basic trading services;
(F) have to ensure that online transactions and information on the legitimacy and authenticity of the perfect management system, facilities, equipment and technical measures.
Article IX to provide individual consumers with Internet drug trading services, enterprises shall have the following conditions:
(a) established in accordance with the law of the pharmaceutical chain retail enterprises;
(b) the provision of Internet drug trading services to provide Internet drug trading services website has obtained the qualification to engage in the Internet drug information services;
(c) with a sound network and transaction security measures and a complete management system;
(d) with a sound network and trading safety (C) has sound network and transaction security measures and a complete management system;
(D) has the ability to keep complete transaction records, facilities and equipment;
(E) with online consultation, online inquiry, order generation, electronic contracts and other basic transaction services;
(F) the varieties of online transactions have a complete management system and measures;
(VII) has a variety of varieties of drugs compatible with the Internet transactions (VII) with the varieties of online trading compatible with the drug distribution system;
(H) with a licensed pharmacist is responsible for online real-time consultation, and have to save the complete content of the consultation of the facilities, equipment and related management system;
(IX) engaged in trading services for medical devices, should be equipped with medical equipment related professional qualifications, familiar with the relevant laws and regulations of the medical device full-time professional staff.
Article 10 The application to engage in Internet drug trading services, enterprises should fill out the State Food and Drug Administration issued a unified "engaged in Internet drug trading services application form" (Annex 2), to the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department to apply, and submit the following materials:
(a) to provide Internet drug trading services (a) to provide Internet drug trading services, the website is permitted to engage in Internet drug information services, a copy of the license;
(b) business development plans and related technical solutions;
(c) to ensure that the transaction of users and trading of medicines is legitimate, real, safe management measures;
(d) a copy of the business license;
(e) to protect the network and the transaction of security management systems and measures;
(f) to ensure the security of the network and the transaction of security management systems and measures;
(h) to ensure the security of the Internet drug trading service;
(vi) copies of identity certificates, academic certificates and resumes of prescribed professional and technical personnel;
(vii) summary table of instruments and equipment;
(viii) description of basic business processes to be carried out and related materials;
(ix) certifying documents of the legal representative of the enterprise and the table of functions of the organization of each department of the enterprise.
Article 11 Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration received the application materials, within five days of the application materials for formal review. Decide to accept, issue a notice of acceptance; decide not to accept, shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
Article XII of the application materials are not standardized, incomplete, provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration shall receive the application materials within five days from the date of a notice to the applicant needs to make corrections to all the contents; late notification, since the date of receipt of the application materials shall be accepted.
Article XIII of the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department acceptance of drug manufacturers, pharmaceutical companies and medical institutions to provide Internet drug trading services, the application shall be submitted to the State Food and Drug Administration within 10 working days of the relevant application materials.
The State Food and Drug Administration in accordance with the relevant provisions of the application materials for review, and within 20 working days to make a decision to agree or not agree to carry out on-site acceptance, and notify the applicant in writing, while copying the acceptance of the application of the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments.
The State Food and Drug Administration agreed to carry out on-site inspection, should be within 20 working days of the applicant according to the acceptance criteria for the organization of on-site inspection. Acceptance failed, notify the applicant in writing and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation according to law; acceptance, the State Food and Drug Administration shall, within 10 working days to the applicant issued and delivered to agree to engage in Internet drug trading services, Internet drug trading service organizations qualification certificate.
Article 14 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments in accordance with the relevant provisions of the Internet drug trading services through their own Web site with other enterprises outside the members of the enterprise drug manufacturers, drug wholesalers and individual consumers to provide Internet drug trading services to the applicant to submit the material for approval and within 20 working days to make a decision to agree or Do not agree with the decision to carry out on-site acceptance, and notify the applicant in writing.
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration agreed to carry out on-site inspection, should be organized within 20 working days of the applicant for on-site inspection. Acceptance failed, notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law; acceptance, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department shall, within 10 working days to the applicant issued and delivered to agree to engage in Internet drug trading services, Internet drug trading service organization qualification certificate.
Article 15 The State Food and Drug Administration and provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department of the applicant's application for review, found that the administrative licensing matters directly related to the significant interests of others, it shall notify the interested party, and listen to the applicant, the interested party's statement and defense. Should be heard in accordance with the law, in accordance with the provisions of the law to hold a hearing.
Article 16 Provide false materials to apply for Internet drug trading services, (food) drug supervision and management department shall not be accepted, given a warning, within one year, the enterprise will not be accepted to engage in Internet drug trading services application.
Provide false materials to apply for Internet drug trading services to obtain Internet drug trading services qualification certificate, (food) drug supervision and management department shall revoke its Internet drug trading services qualification certificate, within three years will not be accepted to engage in Internet drug trading services application.
Article 17 In accordance with the law to obtain (food) drug supervision and management department issued by the Internet drug trading services qualification certificate, the applicant shall, in accordance with the "Internet Information Service Management Measures", according to law, to obtain the appropriate telecommunications business license, or to fulfill the corresponding record-keeping procedures.
Article 18 The provision of Internet drug trading services must be provided in the home page of its website prominently marked Internet drug trading services qualification certificate number.
Article 19 The provision of Internet drug trading services must be strictly audited to participate in the Internet drug trading drug manufacturers, drug companies, medical institutions engaged in drug trading qualifications and the legitimacy of their trading drugs.
For the first time on the Internet transactions of drug manufacturers, drug companies, medical institutions and drugs, to provide Internet drug trading services, enterprises must obtain, audit the qualification documents of the parties involved in the transaction and drug approval documents and for the record.
Article 20 through its own Web site and members of the enterprise other than the Internet drug trading drug manufacturers and drug wholesalers can only deal with the production of the enterprise or the enterprise's business of drugs, may not use its own Web site to provide other Internet drug trading services.
Article 21 to provide Internet drug trading services to individual consumers of enterprises can only sell online the enterprise business of non-prescription drugs, not to other enterprises or medical institutions to sell drugs.
Article 22 The drug manufacturers, pharmaceutical companies and medical institutions conducting drug transactions on the Internet must be through the (food) drug supervision and management department and the telecommunications business department in charge of the examination and approval of the Internet drug trading service enterprises to conduct transactions. Participate in Internet drug trading medical institutions can only buy drugs, not online sales of drugs.
Article 23 The provision of Internet drug trading services to change the website URL, business name, business legal representative, business address and other matters, you should fill out the "Internet drug trading services to change the application form" (see Appendix 3), and in advance of 30 working days to the original approval department to apply for changes in the procedures for the change process is the same as the original application procedures. Change the scope of services of the original qualification certificate is withdrawn, according to the provisions of the re-application, re-approval.
Article 24 of the Internet drug trading services to provide businesses need to rest, shut down for more than six months, it should be stopped before the service one month to the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management departments to submit a written application for the record. Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department received the record application, it should be within 10 working days to notify the telecommunications regulatory authorities.
In the validity of the Internet drug trading services qualification certificate, the rest of the business, the business needs to resume, it should be filed to the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management departments to apply for re-acceptance, acceptance, before resuming business.
Article 25 The expiration of the qualification certificate of Internet drug trading services, the need to continue to provide Internet drug trading services, the provision of Internet drug trading services, enterprises should be valid within six months before the expiration of the original licensing authority to apply for the replacement of the qualification certificate of Internet drug trading services.
Article 26 The original licensing authority in accordance with the original application procedures for renewal of the application for review, that meet the conditions, to be issued a new certificate; that do not meet the conditions, issued a notice of non-renewal of the certificate and explain the reasons for the original Internet drug trading services qualification certificate by the original licensing authority to retrieve and announce the cancellation of the notice.
The original licensing authority should be in the Internet drug trading services qualification certificate expires before making a decision on whether to grant a license. Late decision, deemed to be allowed to renew the license, the original licensing authority shall be within 30 working days to complete the formalities.
Article 27 According to the provision of Internet drug trading services, written applications, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments can recover the Internet drug trading services qualification certificate, reported to the State Food and Drug Administration for the record and announcement of cancellation. Internet drug trading service organization qualification certificate is withdrawn, shall not continue to engage in Internet drug trading services.
Article 28 did not obtain the qualification certificate of Internet drug trading services, unauthorized engagement in Internet drug trading services or Internet drug trading services beyond the validity of the qualification certificate, (food) drug supervision and management department ordered to make corrections within a certain period of time, be given a warning; the circumstances are serious, transferred to the competent department of the information industry and other relevant departments in accordance with the relevant laws and regulations shall be punished.
Article 29 of the Internet drug trading services to provide one of the following circumstances, (food) drug supervision and management department shall order rectification within a specified period of time, be given a warning; the circumstances are serious, revoke the qualification of its Internet drug trading services, and cancel its Internet drug trading services qualification certificate:
(a) in its website home page is not prominently marked Internet drug trading services qualification certificate number; (b) the Internet drug trading services qualification certificate number. (a) Failure to mark its Internet drug transaction service organization qualification certificate number prominently on the homepage of its website;
(b) Provision of Internet drug transaction services beyond the scope of the audit;
(c) Existence of affiliation, property right or other economic interest relationship between the enterprise providing services for Internet drug transactions between drug manufacturing enterprises, drug business enterprises and medical institutions, and the administrative authorities, medical institutions and drug manufacturing and business enterprises;
(d) Failure to mark its Internet drug transaction service organization qualification certificate number prominently on the homepage of its website. Other economic interests;
(D) the changes have not been approved.
Article 30 The provision of Internet drug trading services for unauthorized enterprises or institutions trading unapproved drugs to provide services, (food) drug supervision and management departments in accordance with relevant laws and regulations to impose penalties, revoke its Internet drug trading services qualifications, and cancel its Internet drug trading services qualification certificate, and at the same time transferred to the competent departments of the information industry and other relevant departments in accordance with relevant laws and regulations to be punished. Department in accordance with relevant laws and regulations to be punished.
Article 31 For drug manufacturers, drug companies and medical institutions to provide services for Internet drug transactions between enterprises directly involved in the drug business, (food) drug supervision and management departments in accordance with the "Chinese People's Republic of China *** and the State Drug Administration Law" Article 73 to be punished, revocation of its Internet drug trading services qualification, and cancel its Internet drug trading service organization qualification certificate, while transferring to the information industry authorities and other relevant departments in accordance with the relevant laws and regulations. Qualification certificate, and at the same time transferred to the information industry department and other relevant departments in accordance with relevant laws and regulations to be punished.
Article 32 If a pharmaceutical chain retail enterprise that provides Internet drug transaction services to individual consumers sells prescription drugs online or sells drugs to other enterprises or medical institutions, the drug administration department shall impose penalties in accordance with the laws and regulations on drug management, revoke the qualification of its Internet drug transaction service organization and cancel its qualification certificate of its Internet drug transaction service organization, and at the same time transfer it to the information industry department and other relevant departments for punishment in accordance with the provisions of relevant laws and regulations. At the same time transferred to the information industry department and other relevant departments in accordance with relevant laws and regulations to be punished.
Article 33 The drug manufacturers, drug companies and medical institutions through the Internet drug trading services without approval or beyond the approval of the scope of the Internet drug trading business for Internet drug trading, (food) drug supervision and management department ordered to make corrections, given a warning.
Article 34 (food) drug supervision and management departments in the Internet drug trading service approval in violation of the "Chinese People's *** and the State Administrative Licensing Law," the seventy-second, seventy-third, seventy-fourth, seventy-seventh provisions of the situation, in accordance with the relevant provisions of the treatment.
Article 35 (food) drug supervision and management departments shall provide Internet drug trading services on the website for supervision and inspection, and the inspection will be announced to the public.
Article 36 Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration can be based on the provisions of the specific audit requirements and procedural provisions, and reported to the State Food and Drug Administration for the record.
I think it's better to leave it to the CRO! Clinical trials are complicated!
Can medical devices be bought and sold online?Trading online for medical devices is not very mature, and considering that customers can really get the products they need, it is better to use the internet as a platform to understand the products in detail and communicate with the manufacturers for consultation before making a choice. You can go to safute. to see if there are products you want.