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Medical devices have become a new growth engine for giants, and third-party logistics has ushered in major new regulatory regulations

 Last Update: 2022-11-15
 Source: Internet
 Author: User

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A few days ago, the State Medical Products Administration officially issued the Appendix to the Good Management Practice for Medical Device Operation: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services (hereinafter referred to as the "Appendix") to standardize the quality management of enterprises specializing in providing medical device transportation and storage services, ensure the quality and safety of medical devices in transportation and storage, and promote the high-quality development of
the medical device logistics industry.

Enterprises specializing in providing medical device transportation and storage services, commonly known as: medical device third-party logistics
.
The Appendix, which will come into force on January 1, 2023, clearly states that enterprises specializing in the transportation and storage of medical devices shall abide by medical device laws, regulations, rules and specifications, and be responsible for
the quality of the transportation and storage process of medical devices.

IVD quality management has special requirements

The Appendix issued this time consists of 7 chapters and 48 articles, which put forward specific requirements
for medical device third-party logistics enterprises from the aspects of establishment and improvement of quality management system, institutions and personnel, facilities and equipment, computer information systems and quality responsibilities.

The Appendix clarifies: enterprises specializing in the transportation and storage of medical devices shall have the basic conditions and management capabilities to engage in modern logistics, transportation and storage business, have the ability to synchronize electronic data in real time with the entrusting party, have a computer information system that realizes the traceability of the whole process of medical device transportation and storage services, establish and operate a quality management system covering the whole process of transportation and storage services, and ensure the quality, safety and traceability of medical device products in the entrusted transportation and storage process
。

The Appendix requires that enterprises specializing in providing medical device transportation and storage services shall establish a quality management organization to be responsible for the quality management
of medical device transportation and storage services.
The quality management institution shall be equipped with quality management personnel appropriate to the scale of transportation and storage services provided, and at least 2 of the quality management personnel shall have a college degree or above or a professional and technical title at or above the intermediate level, and shall have more than 3 years of experience
in medical device quality management.
The legal representative, person in charge of the enterprise, the person in charge of quality, and the quality management personnel of the enterprise specializing in providing medical device transportation and storage services shall meet the qualification requirements
stipulated in the "Medical Device Operation Quality Management Specification".
Enterprises specializing in providing medical device transportation and storage services shall set up a person in charge of quality, who shall in principle be the senior management of the enterprise, and the person in charge of quality shall independently perform his duties, have the right to adjudicate on the quality management of medical devices within the enterprise, and bear the corresponding quality management responsibilities
.

For medical devices engaged in in in vitro diagnostic reagents, implantation and intervention, the Appendix specifically proposes that at least one quality management personnel engaged in in vitro diagnostic reagents shall be the competent examiner or have a college degree or above or intermediate or above professional and technical titles in laboratory related majors (including laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, medical devices, etc.
), and shall have more than 3 years of medical device quality management work experience
。 Personnel engaged in the acceptance of in vitro diagnostic reagents shall have a technical secondary school degree or above in laboratory science or have the professional and technical title
of primary or above as an inspector.

When entrusting the transportation and storage of products for implanted and interventional medical devices, enterprises specializing in providing medical device transportation and storage services shall also strictly implement the relevant requirements
of medical device laws, regulations, rules and norms for the management of implanted and interventional medical devices.
The purchase inspection records and delivery records of implantable medical devices shall be permanently kept
.

The Appendix clarifies that on the basis of ensuring the quality and safety of medical devices and controllable risks, enterprises are encouraged to make full use of new technologies such as informatization, digitalization, the Internet, and the Internet of Things in the modern logistics industry to promote the implementation of unique identification of medical devices and promote the traceability
of medical devices throughout the process.
Encourage enterprises to develop intensively, integrated and digitally, adopt new technologies to develop modern logistics, and improve the ability
of medical device supply guarantee services.

There is no leader in the third-party logistics of medical devices

In recent years, China's medical device third-party logistics industry has developed rapidly
.
According to data released by the Medical Device Supply Chain Branch of the China Federation of Logistics and Purchasing, as of the end of March 2022, there were 513 third-party logistics enterprises for medical devices in China, which are mainly distributed in the eastern coastal region, the Yangtze River Delta region and the Bohai Rim region
.
The provinces (municipalities directly under the central government) with the largest number of third-party logistics enterprises for medical devices are Jiangsu Province, Hubei Province, Shanghai Municipality and Beijing Municipality
.

In order to better supervise and manage the third-party logistics of medical devices and ensure the safety of equipment, in recent years, various provinces (cities) have also issued a number of special supervision policies
for third-party logistics of medical devices.

For example, in the newly issued "Implementation Rules of Beijing Medical Device Operation Supervision and Administration Measures (Draft for Comments)", for enterprises that provide third-party logistics services for medical devices, enterprises are required to meet some hard conditions in addition to meeting the requirements of the "Good Management Practice for Medical Device Operation": the total area of the warehouse providing medical device storage services shall not be less than 3000 square meters, and multiple sub-warehouses can be set, but the use area of the main warehouse shall not be less than 1500 square meters.
The use area of the sub-warehouse shall not be less than 500 square meters, and it shall have storage conditions
suitable for the scale of the business scope.
Modern logistics storage and transportation facilities and equipment are required; With a comprehensive medical device information logistics management system, it shall at least include a warehouse management system and a transportation management system, and provide cold chain transportation services for medical devices, and a cold chain transportation traceability system
shall also be established.

The hard requirements for warehousing in Shanghai are: the third-party logistics of medical devices should have storage conditions and facilities and equipment suitable for product storage and transportation requirements, with a special warehouse for medical devices, with an area of not less than 5,000 square meters, and a cold storage volume of not less than 1,000 cubic meters
for storing and transporting in vitro diagnostic reagents.

The reporter inquired about a number of local policies, and the hard requirements for the storage area of medical device third-party logistics companies appeared in the policies of many provinces and cities, and 3,000 square meters and 5,000 square meters were two more common standards
.
In addition, most provinces also require enterprises to be able to connect data with the electronic supervision interface of local regulatory authorities in real time to achieve traceability
of the whole process of product operation.

With the professional trend of social division of labor, the intensive mode of medical device logistics has effectively achieved cost reduction and efficiency improvement, and through effective administrative license management and process quality supervision, enterprises specializing in providing medical device transportation and storage services have also provided storage and transportation quality and safety assurance capabilities
that are superior to ordinary operating enterprises.

Qin Yuming, Secretary-General of the Medical Device Supply Chain Branch of the China Federation of Logistics and Purchasing, said: "Guiding and standardizing the healthy, sustainable and high-quality development of enterprises specializing in the transportation and storage of medical devices is crucial
to improving the efficiency of the medical device supply chain, reducing social costs, and product quality and safety.
The report released by the branch also shows that compared with the maturity of the pharmaceutical third-party logistics market, the medical device third-party logistics market is relatively immature, and there is no representative leader in the industry
.

Devices have become a new engine for the growth of pharmaceutical business giants

At present, the third-party logistics enterprises of medical devices in the market can be roughly divided into three categories
: traditional medicine circulation enterprises, professional medical device logistics enterprises and social logistics enterprises.
The three types of enterprises have their own advantages, under the continuous changes in the market environment and the superposition of various policies, the reshuffle of the equipment logistics market has intensified, both the same industry, different industries cooperation resource sharing, competition is also intensifying
.

In particular, the implementation of the two-invoice system and centralized procurement of medical devices has greatly reduced the terminal price of products, and the profit margin of the circulation link has also been greatly compressed, and the implementation of these policies has had a far-reaching impact
on the overall format of China's medical device business field.

An industry analyst told reporters that under the multiple influences of policies and markets, traditional pharmaceutical circulation giants such as Sinopharm Holdings, Shanghai Pharmaceutical, China Resources Pharmaceutical, Jointown and other enterprises have also explored the diversified development
of medical device business.
These leading enterprises have strong resource advantages, channel advantages, advanced technology integration and efficient integrated logistics supply chain, occupying the main share of
the medical device third-party logistics market.
These enterprises not only provide distribution, warehousing, distribution, but also actively explore and innovate, and vigorously develop innovative service models
such as SPD (Supply Processing Distribution).

The SPD model is commonly referred to in the medical device industry: medical materials supply chain management service, which is a new management model in which medical institutions have emerged in recent years to cooperate with external enterprises to realize the ordering, supply, transportation, warehousing, consumption management and other integrated supply of
medical materials to improve the efficiency of the hospital supply chain.
Because this model can improve the operational efficiency of medical institutions, save storage space and reduce costs, the SPD management mode of medical devices has been applied
by more and more medical institutions in China.

According to Sinopharm's 2022 half-year report, more than 1,500 centralized distribution and SPD projects were being carried out during the reporting period, and more than 150 new SPD projects and centralized distribution projects were added in the first half of this year alone, opening up the last mile
of medical consumables distribution.

According to the annual report of Jointown, in 2021, the medical device sector achieved sales of 24.
014 billion yuan, a year-on-year increase of 12.
55%, accounting for 19.
62%
of the company's overall sales 。 In its performance briefing announcement, Jointown said that the main reason for the steady growth of the device business is that the company actively communicates with manufacturers of volume-based procurement products, strengthens the cooperative relationship between the two parties, and adopts innovative models to adapt to volume-based procurement, including strengthening communication with manufacturers of coronary stents, orthopedics, pacemakers, drug balloons, crystals, and PTCA guideribbon products, and has achieved 274,200 coronary stent distribution, accounting for 19%
of the industry 。 In the first half of 2022, the Jointown medical device sector focused on six core track product lines of major surgery and intervention, orthopedics, medical equipment, IVD, household devices, and nursing consumables, and achieved sales of 14 billion yuan in the first half of the year, a year-on-year increase of 18.
06%.

CR Pharma has also vigorously promoted the professional development of medical device distribution business in 2021, and has established independent medical device companies in 17 provinces, continued to deepen the development of orthopedics, interventional, IVD diagnostic reagents, comprehensive consumables and other key development areas, continued to improve the professional marketing capabilities of product lines, and has established 14 orthopedic branches in Guangdong, Jiangsu, Shandong and other provinces, and established professional line marketing organizations
in 14 regions.

Industry experts said that third-party logistics of medical devices not only needs to provide more professional customized services, but also needs to further enhance the ability
of enterprises to resist risk management.
Driven by both policy and market, it is expected that the medical device industry will maintain rapid growth in the future, and the third-party logistics of medical devices is also developing with high quality in the direction of standardization, integration, specialization and digital intelligence
.

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