"Medical Device Network Sales Supervision and Management Measures" Get Praised in Months

Medical Network April 10th March 1st, the "Medicine equipment network sales supervision and management measures" formally implemented. So far, the "measures" have been implemented for more than a month, the industry's understanding of the "measures" and response? Medical equipment network sales How do companies assume their responsibilities? How do food and drug regulatory authorities at all levels do the appropriate supervision and management? With these questions, the reporter conducted an interview.

"The Measures has many highlights that warrant attention." Jiang Haihong, director of the medical device supervision department at the Shanghai Health Medical University, said that the "Measures" are in line with business conditions and industry development needs. They not only specify the network of medical device network sales and medical device transactions. The two major entities that service third-party platform providers sell for the Internet also specify the six obligations that the two main entities should undertake, especially the obligation to fulfill the record.

'People who want to enter this field have taken a certain amount of care.' Jiang Haihong pointed out that the approach to record-based entry management simplifies the handling of procedures and procedures, but it also clearly stipulates what conditions it has and must fulfill. The Measures require providers of medical device network trading services and third-party platforms to sign an agreement with the enterprises settled on the platform, and clarify the obligations of both parties and disposal measures for breach of contract in the agreement. 'Protecting public safety of machinery is not empty talk.'

The "Measures" confirm that holders of medical device marketing licenses can sell medical devices through the Internet just like medical device manufacturing enterprises.

This reflects Regulation The forward-looking nature of the plan will signal the continued advancement of the holders of medical device marketing licenses, said Jiang Haihong.

"The "measures" are more rigorous and more in line with the actual situation. ' Kyushu pass medicine Jiang Zhitao, chairman of the group's health 998 e-commerce group, also believes that the “Measures” take the “People’s Republic of China Cyber ​​Security Law” as one of the legislative foundations to explain the importance attached to cyber security; it clearly clarifies the responsibilities of the regulatory level and increases the provincial level. Bureau's responsibilities, making supervision more systematic; medical instruments produce enterprise Separate declaration from holders of medical device marketing licenses, in line with current industry trends.

"The "Measures" provide a legal basis for the development of the medical device network trading industry, allowing the medical device network sales practices to be enforced, which will promote the healthy and orderly development of the industry, and will help companies with standardized operations to become bigger and stronger.' Jiang Zhitao said , 'Strength, meet the requirements of the companies will get more market opportunities. And those who are not qualified, non-standard enterprises will be eliminated, the industry concentration will also be improved.'

At the same time, he also believes that the medical equipment network transaction enters the rational management stage, which will further accelerate the expansion of the industry scale.

"The "Measures" have clear requirements for the qualifications of the Internet medical device sales platform, and also made principled requirements and directional guidance for the operation of the Internet medical device sales platform, reflecting the country's concern for the quality of online sales of medical devices.' Zhang Linan, head of Alibaba's health quality management, said that when the merchant settles in Ali Health, he will undergo a rigorous audit. The second type of medical device business needs to provide a medical device operating license or a record card, and also provide other qualifications such as brand authorization. You can enter the platform to open stores, Ali Health will be bound by the business of the business scope of their business categories. On-line business operations, the platform will continue to follow the management and control through technical means, in the sale of equipment products if there is a violation , will be automatically intercepted, shielded; for illegal products and businesses, respectively, off the shelf, deductions, deletions, store supervision, clearance and other diversified control methods.

'We also adopted a series of measures to incentivise businesses to further improve service quality. ' Zhang Nan said that consumer online shopping equipment products can enjoy a refund-free worry-free service. If users purchase contact lenses with the 'eye protection' logo, In the course of use, it can cause redness, itching, blurred vision, etc. It can enjoy the return and refund service within 30 days of receipt.

"The "Measures" follow the principle of "consistent online and offline," providing a more comprehensive institutional guarantee for online sales channels and ensuring the quality of products sold online. 'The chairman of the Rehab Home Health Management Group, Bo Hao, said that For the retention and traceability of transaction record data, if it can be implemented strictly in accordance with the “Measures”, then online sales will have better medical device display than physical stores, flow control and service tracking, and product recall management. 'Because Due to various factors, many buyers of physical stores are reluctant to fill in the warranty card in detail, which poses certain obstacles to the management of the flow of products such as flow control and recall.

Immediately after the issuance of the "Measures", local supervisory authorities are also stepping up the development of detailed implementation rules for their own jurisdictions to ensure the implementation of the "Measures" and landing.

March 9, Nanchang Food drug The Supervisory Authority handled the first medical equipment network sales record in Jiangxi Province for Jiangxi Tongteng Chain Pharmacy Co., Ltd. The efficient and efficient work efficiency was praised by the company. It is understood that the Bureau has established a medical service network sales record guide in time. It was announced on the Bureau Administration website on March 1. At the same time, the staff of the appraisal window was trained to ensure the uniform standards of the staff and to have the ability to conduct formal examinations and handle on the spot.

On March 12, Beijing Municipal Food and Drug Administration organized and formulated the "Detailed Rules for the Implementation of the Measures for the Supervision and Administration of Medical Device Network Sales in Beijing (Trial)" to complete public comments. Based on the "Measures", Beijing Municipality has formulated a plan for Beijing. The supporting documents for regional industry characteristics further clarify the responsibilities and regulatory requirements of the main body of medical device network sales from the system level, such as specifying the specific conditions for office space and computer systems, and clarifying what the quality management organization should have. , what kind of organizational structure to establish, etc.

It is reported that the national medical device network transaction monitoring platform was put into use at the end of March this year. At present, the Guangdong Food and Drug Administration is opening a working account for the city-level food and drug supervision and administration authority and assigns the use authority, assigning someone to be responsible for the monitoring of information transfer, investigation To handle status feedback and statistical analysis, etc., to do a good job in the disposal of medical device network sales and transaction monitoring information; At the same time, strengthen the supervision and management of enterprises engaged in medical device network sales in the province and providers of medical device network trading service third-party platform , Initiated training for companies and third-party platform providers of medical device network trading services, and urged them to fulfill their main responsibilities.

"The "Measures" make up for the lack of regulatory and law enforcement grounds for the original medical device network trading business and keep pace with the current development of the industry. " Jiang Zhitao said, 'Looking forward to follow-up regulatory policy while playing a regulatory role, but also continue to Keeping pace with the development needs of the industry, such as the medical equipment network leasing business, the after-sales value-added services for medical devices using Internet technology, etc., are also involved and improved.