This post (journalist seo jianhua) is part of our special coverage of the world cupNational drug authorityPublication of the internet medical device information serviceManagement requirements(hereinafter referred to as “the regulations”). The regulations are in force from the date of their publication。
In a total of 14 articles, the regulations specify the content, conditions, working procedures and information requirements of the internet-based medical equipment information service. They represent an important step by the national drug control agency in implementing the spirit of the state council's reform to deepen the “separation of certificates”。
The regulation requires that internet drug medical equipment information service providers (hereinafter referred to as “information service providers”) file with websites, clients, applications as basic modules, unless they are consistent withInternet information servicesIn addition to the requirements set out in the management scheme, there shall be three conditions: information service providers should be legal persons or other organizations established by law; have professionals, facilities and regulatory systems appropriate to the activities of the internet-based medical equipment information service; be equipped with at least two qualified technicians in medicine, medical equipment, relevant laws, regulations and expertise, or medicine and medical equipment。
The regulation makes it clear that an information service provider, prior to providing internet-based medical equipment information services, should provide the local provincial pharmacy department with the name of the unit, the legal representative or principal, the residence, as well as the website, client, the name and domain name of the application, and submit the following information to obtain the file number. Provincial pharmacies should make available to the public, in a timely manner, information on the internet-based medical equipment information service and, within three months from the date of completion of the file, review the authenticity and regulation of the records and, if necessary, organize on-site inspections. If the conditions for filing are not met, provincial pharmacological authorities should order them to correct the deadline, if they are overdue, to cancel their filing and to make a public announcement。
The regulation emphasizes that the pharmacy department finds three situations in which information service providers have failed to file a complaint for the provision of internet-based medical equipment information services, in violation of articles 7 and 8 of the regulation; and that websites, clients, applications containing medicines, medical equipment information have a negative impact or other security risks, should be ordered to correct the deadline, if necessary by means of such measures as interviewing legal representatives or principals, social announcements, etc. In its inspections, the pharmacist department has found that websites, clients, applications are suspected of violating the management of internet information services and other relevant laws and regulations, and should be referred to the competent authorities for investigation and disposal in accordance with the law。
The national drug authority indicated that the introduction of the regulations will further regulate the management of the internet-based pharmaceutical medical equipment information service and will effectively guide local regulatory processes。
