Medical equipment logistics inspection is coming! Sinopharm, medicine is included

Medical Network July 30th From the day after tomorrow, a large number of medical equipment third-party logistics companies in Shanghai will usher in a three-month inspection, including Chinese medicine and medicine.

On July 25, the Shanghai Food and Drug Administration issued the “Notice on the Special Inspection for the Provision of Medical Device Storage and Distribution Service Enterprises”, which will conduct special inspections for all third-party medical device logistics service providers in the city, from August 1st. Start, continue until October 31.

The notice clarified that the object of inspection is that the medical device business license was obtained before the end of 2017, and the business scope of the license includes 'providing storage and distribution services for other medical device manufacturing enterprises', a total of 31 enterprises, including The two licenses expired.

Among the remaining 29 distribution companies, Sinopharm, Kyushutong, Shanghai Pharmaceutical, FedEx and other large third-party logistics companies are included.

From the inspection content, the main focus is on whether to exceed the licensing matters for distribution services, including the authenticity of the information, for example, whether the actual storage and transportation of the third-party logistics enterprise is consistent with the licensing items, whether according to the medical device product label, the marking requirements Whether the product is stored, transported, and the real-time regulatory information platform provided to the regulatory authorities is true and consistent with the actual situation.

Whether the licensing of the Medical Device Business License is consistent with the actual situation; if the three-party logistics service is not actually carried out, whether the licensed medical device warehouse is used for other purposes.

Whether the entrusted enterprise has the qualification for the production and operation of medical devices; whether the products entrusted with storage or distribution are legal products registered or filed.

Whether to sign a quality assurance agreement with the entrusting party, whether the entrusting party conducts an annual audit, find problems and implement rectification

After obtaining the "Medical Device Business License", whether it has already provided storage and distribution services for other medical device manufacturing enterprises; whether it is for medical device production, business enterprises provide false commissions.

Whether the person in charge of quality, quality management personnel has changed, is familiar with the laws related to medical device management Regulation Requirements; Whether the quality management personnel engaged in cold chain storage and transportation meet the requirements; If the above personnel have been changed, whether to maintain the quality related personnel change information maintenance in the "Shanghai Medical Device Management Enterprise Product Information Retrospective Declaration System".

Whether the operation of the computer management system is in line with the requirements for the development of the three-party logistics of medical equipment, the acceptance record of printing, the warehousing record, and whether the accompanying counterparts meet the specified requirements.

Whether the information provided to the real-time regulatory information platform of the regulatory authorities meets the requirements, is it true and effective; randomly checks the inventory products, and checks whether the data is consistent with the real-time regulatory information platform data.

Whether the cold storage, refrigerated trucks are regularly verified, and equipped with automatic temperature monitoring system, cold chain product receipt, delivery, transportation and transportation process are in compliance with regulatory requirements.

Whether to carry out annual self-examination of medical device quality management specifications, whether the self-examination problem has been rectified; whether the problems found in the previous year's special inspections have been rectified.

Whether to store the medical device products according to the product label and labeling requirements (focus on inspection and storage, transportation of medical equipment products with special requirements), return products, non-conforming product division and disposal meet the requirements; if there are self-operated products, Whether it is stored separately from the entrusted product.

If there is a non-compliance with the inspection result, it is necessary to rectify within a time limit. On-site inspection of suspected violations requires further investigation. After fixing the on-site evidence, it shall be filed in time.

In fact, this big inspection did not come suddenly. As early as April 3 this year, the Shanghai Food and Drug Administration held a Shanghai medical equipment third-party logistics enterprise supervision work conference, and the city's 30 medical equipment third-party logistics companies were responsible. People, quality leaders attended the meeting.

At that time, one of the requirements of the chief engineer of Zhou Qun for the participating enterprises was to cooperate with the pilot work of the medical device registrant system and the development of medical device production and operation enterprises to provide high-quality, internationally-oriented logistics storage and transportation services.

Nowadays, the medical device registrant system has been promoted throughout Shanghai, and will be implemented simultaneously in Jiangsu and Zhejiang, or it can be boldly foreseen. The inspection of third-party logistics of medical devices will also spread to Zhejiang and Jiangsu provinces.

Many years ago, Shanghai took the lead in exploring the pilot project of third-party logistics for medical devices. After years of development, there are currently 30 companies in Shanghai that can provide third-party logistics services for medical devices. There are still many companies ready to submit applications. This is still very welcome.

Since the launch of the “Measures for the Supervision and Administration of Medical Device Management” in 2014, the third-party logistics market for medical devices has been completely opened. Several provinces have issued documents to promote the pilot work of third-party logistics for medical devices, including Beijing, Shanghai, Guangdong, Jiangsu, Jiangxi, Yunnan, Zhejiang, Anhui, Sichuan, Chongqing, Liaoning, Fujian, Tianjin, and recently issued documents Ningxia, Sichuan and so on.

Medical machinery circulation enterprises medicine The circulation enterprises have a certain degree of overlap, but they are all occupied by several large pharmaceutical circulation groups. The enterprises that have become giants in the circulation of medical equipment have not yet, and the market is in a small and scattered situation. Under this situation, the circulation enterprise service profession There are not enough people, even those who provide delivery services beyond the licensing issues. This is why many provinces have encouraged documents to encourage large-scale distribution companies to merge small circulation enterprises.

Shanghai as a medical instruments The pilot of third-party logistics, coupled with a highly developed economy, is more mature than other regions. The problems found in this inspection are in line with the implementation of the medical device registrant system. It will also be used for future inspections in Zhejiang and Jiangsu. The reorganization of this subdivision will begin.

Attachment: Shanghai Medical Equipment Third Party Logistics enterprise List