The new national standard GB/T 46857.1-2025 is here. Medical equipment operation and maintenance services are about to be “upgraded.” Is your company ready?
Today, let’s talk about a newly released hot topic: the national standard Medical Equipment Operation and Maintenance Services—Part 1: General Requirements (GB/T 46857.1-2025). This standard was just issued on December 31, 2025, and will take effect on July 1, 2026.
Imagine this: when hospital equipment broke down in the past, maintenance often felt somewhat disorganized. Now, the government has issued a “general guide.” It is much like having an official service manual for maintaining your car—making everything more reliable and efficient. Let’s take a look at what this means, how other companies are viewing it, and what should be considered in practical implementation.
Let’s first get familiar with this new standard and briefly see what it covers.
This standard was led by the National Medical Equipment Industry and Application Standardization Working Group (SWG26). It is a recommended standard rather than a mandatory one, but it sends a strong signal to the industry. It mainly addresses medical equipment operation and maintenance services, such as routine maintenance, fault repair, and quality control, and provides a set of general requirements. Its scope covers the entire chain from hospitals to manufacturers, with the aim of making services more standardized and safer while avoiding the awkward situation where equipment suddenly fails and clinicians are left scrambling.
Why is it important? Consider that medical devices are becoming increasingly intelligent and complex. Inadequate operation and maintenance affects not only efficiency, but may also have implications for patient safety. The government’s strong focus on this area clearly reflects recognized industry pain points and an intention to drive upgrading through standardization. To use a simple analogy, it is like moving from everyone servicing vehicles in their own way to having a “nationally unified maintenance manual.” In the long term, this can help companies reduce costs, mitigate risk, and strengthen competitiveness.
How are other companies responding to this standard? Let’s take a closer look.
I specifically looked into this, because the standard has only just been released and market reactions are still very new. Unfortunately, given the very short time since publication—only about half a month—there has not yet been much publicly available commentary, whether positive or critical. Most stakeholders are likely still digesting it. However, the drafting process itself shows that quite a number of major companies were deeply involved, which in itself says a great deal about their position.
For example, the drafting organizations include companies such asShenzhen Mindray Bio-Medical Electronics Co., Ltd.、Shanghai United Imaging Healthcare Co., Ltd.major domestic leaders such as these, as well asSiemens Healthcare Systems Co., Ltd.、Philips (China) Investment Co., Ltd.These international players were not merely observing; they directly contributed input and experience. So I can say with confidence that these companies welcome the standard—after all, participating in its development means they recognize that this type of framework can help the industry improve quality and efficiency. Based on experience with similar standards (for example, previous medical device quality management standards), these companies typically respond proactively because standardization can help them optimize supply chains, reduce compliance costs, and even expand into new service and maintenance markets.
Of course, not every company will find the transition entirely smooth. Some small and mid-sized service providers may feel that this is simply one more set of rules, but from an industry-trend perspective, more stakeholders are seeing opportunity. Companies such as United Imaging and Mindray have already invested considerably in intelligent service and maintenance over the past few years, and this standard now gives those efforts additional official endorsement, making their products and services more competitive. I expect that over the coming months, more companies may voice their perspectives—for example, by sharing implementation experience at industry conferences or on their official websites. If you know colleagues in the sector, it may be worth asking for their views; I think it would be an interesting discussion.
What should you pay attention to during implementation? A few practical tips
Now that we have covered the theory, let's move to some practical recommendations. Remember, this is a voluntary standard, so there is no need to panic—but early preparation brings early benefits. Below are a few points I have summarized based on industry developments, shared purely from experience rather than as mandatory requirements:
Assess your current service and maintenance processes: Start with an internal review: have your company's equipment maintenance processes already been standardized? For example, do you have clear service workflows and risk management mechanisms? If not, organizing them now can help you avoid a rushed implementation later. Think of it like backing up data before upgrading a phone operating system—stability comes first.
Training and team capability upgrade: Service and maintenance operations involve multiple stakeholders, including technical personnel and hospital users, and this standard emphasizes general requirements, so additional training may be needed. It may feel burdensome, but it is really an investment—when employee capabilities improve, corporate competitiveness rises as well. Some companies have already started internal workshops that you can learn from.
Costs and opportunities go hand in hand: Implementation may increase upfront costs, such as software updates or tool procurement, but over the long term it can reduce failure rates and improve customer satisfaction. For exporters in particular, alignment with a national standard can also support alignment with international requirements such as ISO 13485 and help open larger markets. I have heard that some service companies are already developing smart O&M apps based on this standard—isn't that a new opportunity?
Stay attentive to subsequent parts: This is Part 1, and additional detailed provisions may follow. It is advisable to monitor updates from the Standardization Administration of China or join industry discussion groups. If questions arise, you can also consult experts from the drafting organizations, who are often willing to share their experience.
Overall, this standard is not a straitjacket; it is a catalyst for industry upgrading. If your company is grappling with service and maintenance challenges, this is an excellent time to get started.
Finally, what are your thoughts?
Has this new standard resonated with you? If you work in the medical device sector, feel free to share your perspective in the comments—do you see it driving significant change, or do you have concerns? Let's discuss it together; new ideas may emerge from the exchange. If you enjoy this type of content, follow along and I will continue to explore more developments across the industry. Until next time, stay curious. 😊