June 21, the State Drug Administration issued a "network medical device management supervision and management approach (draft)" (hereinafter referred to as "draft"), for the public to solicit opinions, feedback time as of July 22, 2017 The Prior to March 29, the State Drug Administration has also hung out the "network of medical equipment to operate illegal practices (draft)", for the local drug regulatory authorities to seek feedback. It can be noted that, with the March hanging out of the "network of medical equipment to operate illegal investigation and handling methods (draft)", the new version of the "draft" in the content and there are many new changes.
First of all, the most intuitive is the name of the file changes, from the "net sales of medical equipment to investigate and deal with violations" into "online sales of medical equipment regulatory approach." Obviously, the new file name and the existing medical equipment production, management, use of regulatory methods are more consistent.
Second, in the retention of the old documents, "let go of online sales of medical equipment, the record can be" on the basis of the provisions of the new documents on the sale of medical equipment supervision is more stringent.
The new version of the "draft" on the changes in the new content is mainly reflected in the following aspects:
1, the new version of "draft" proposed, engaged in the network of medical equipment business enterprises, should be through self-built website or the filing of the network of medical equipment trading services third-party platform to carry out online sales of medical equipment activities. - This is a clear definition of the new document. In addition, the new version of "draft" proposed, whether self-built website business, or third-party trading platform, should have the appropriate size of the office space, and to protect the relevant network management medical device data and data reliability, Safety, traceability. - Old documents do not have requirements for office space, and only require protection of data and information on the reliability and security. "Traceability" has become a new document on the medical device network operators a new requirement.
2, the new version of "draft" clearly stipulates that engaged in the sale of medical equipment business must also comply with the field of medical equipment, the relevant laws and regulations, which includes the requirements of third-party trading platform. The old clause of the article is not specifically put forward this point, only the integrity of the legitimate provisions of this piece of business.
3, the new version of "draft" proposed, engaged in the network of medical equipment business enterprises, in addition to "access to medical production, business license or for the record", it should be medical equipment production and operation of the entity business. - There must be no matter what must be the entity enterprise.
4, the new version of "draft" clearly put forward, medical equipment wholesale enterprises engaged in network medical equipment business, should be sold to a qualified business enterprises or the use of units, medical equipment retail enterprises engaged in network medical equipment business, should be sold to consumers. This is not clearly defined in the old version of the draft.
5, the new version of "draft" provides that the third-party online sales platform in the record, must submit a "medical device quality and safety administrator copy of identity." In addition, the new version of "draft" proposed that the third-party online sales platform should be prominently in the site and timely notice of product quality and safety risks and other related information, should also regularly on the platform of medical device products for sampling test, test unqualified products immediately Off the shelf. The emergence of the new content, indicating that the drug sector on the network of medical equipment, quality management requirements and become more severe.
6, the new "third-party online sales platform for the protection of consumer rights" content. The new version of the "draft" proposed that the third party sales platform did not take the necessary measures to stop the enterprise within the platform against consumer rights, and enterprises to share joint and several liability.
7, the new "online sales of medical equipment record information must be changed in time" requirement. The new version of the "draft" proposed, online sales of medical equipment related to the record information changes, it should be timely changes in the record, offenders by the drug supervision order correction, given a warning, refused to correct the fine 5000-20000 yuan.
8, to provide false record information more stringent punishment. The new version of the "draft" proposed, filing false information provided by the drug regulatory department to the public notice of the record unit, the circumstances are serious, the direct responsibility of 5 years shall not engage in online sales of medical equipment business.
Whether it is offline, or online sales of medical equipment, the compliance of the field of medical equipment must comply with the rules and regulations, the line is not extrajudicial!
First of all, the most intuitive is the name of the file changes, from the "net sales of medical equipment to investigate and deal with violations" into "online sales of medical equipment regulatory approach." Obviously, the new file name and the existing medical equipment production, management, use of regulatory methods are more consistent.
Second, in the retention of the old documents, "let go of online sales of medical equipment, the record can be" on the basis of the provisions of the new documents on the sale of medical equipment supervision is more stringent.
The new version of the "draft" on the changes in the new content is mainly reflected in the following aspects:
1, the new version of "draft" proposed, engaged in the network of medical equipment business enterprises, should be through self-built website or the filing of the network of medical equipment trading services third-party platform to carry out online sales of medical equipment activities. - This is a clear definition of the new document. In addition, the new version of "draft" proposed, whether self-built website business, or third-party trading platform, should have the appropriate size of the office space, and to protect the relevant network management medical device data and data reliability, Safety, traceability. - Old documents do not have requirements for office space, and only require protection of data and information on the reliability and security. "Traceability" has become a new document on the medical device network operators a new requirement.
2, the new version of "draft" clearly stipulates that engaged in the sale of medical equipment business must also comply with the field of medical equipment, the relevant laws and regulations, which includes the requirements of third-party trading platform. The old clause of the article is not specifically put forward this point, only the integrity of the legitimate provisions of this piece of business.
3, the new version of "draft" proposed, engaged in the network of medical equipment business enterprises, in addition to "access to medical production, business license or for the record", it should be medical equipment production and operation of the entity business. - There must be no matter what must be the entity enterprise.
4, the new version of "draft" clearly put forward, medical equipment wholesale enterprises engaged in network medical equipment business, should be sold to a qualified business enterprises or the use of units, medical equipment retail enterprises engaged in network medical equipment business, should be sold to consumers. This is not clearly defined in the old version of the draft.
5, the new version of "draft" provides that the third-party online sales platform in the record, must submit a "medical device quality and safety administrator copy of identity." In addition, the new version of "draft" proposed that the third-party online sales platform should be prominently in the site and timely notice of product quality and safety risks and other related information, should also regularly on the platform of medical device products for sampling test, test unqualified products immediately Off the shelf. The emergence of the new content, indicating that the drug sector on the network of medical equipment, quality management requirements and become more severe.
6, the new "third-party online sales platform for the protection of consumer rights" content. The new version of the "draft" proposed that the third party sales platform did not take the necessary measures to stop the enterprise within the platform against consumer rights, and enterprises to share joint and several liability.
7, the new "online sales of medical equipment record information must be changed in time" requirement. The new version of the "draft" proposed, online sales of medical equipment related to the record information changes, it should be timely changes in the record, offenders by the drug supervision order correction, given a warning, refused to correct the fine 5000-20000 yuan.
8, to provide false record information more stringent punishment. The new version of the "draft" proposed, filing false information provided by the drug regulatory department to the public notice of the record unit, the circumstances are serious, the direct responsibility of 5 years shall not engage in online sales of medical equipment business.
Whether it is offline, or online sales of medical equipment, the compliance of the field of medical equipment must comply with the rules and regulations, the line is not extrajudicial!