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In a Nutshell: Registering your Medical Device for Chinese Market

In this interview you'll get some insight into what medical device manufacturers need to know if they want to release their medical devices in China.

In a Nutshell: Registering your Medical Device for Chinese Market

We interview Matija Rupnik who is the Regulatory Affairs Manager at ArrowFast. Matija gives us some insight into what medical device manufacturers need to know if they want to release their medical devices on the Chinese market.

So, let’s get started. For our readers who may be new to the world of medical device certification, can you quickly tell us why manufacturers must get their medical devices approved?

Well, the simplest answer is that it is required by law everywhere in the world. But the underlying reasons come down to the two main requirements that all medical devices must satisfy. The first is that the devices must be safe, and safety, by definition is the absence of unacceptable risks. The second requirement is that the medical device must attain the performance and functionality as declared by its manufacturer. The evidence that these two requirements are satisfied comes out of the certification process. Once a device is certified for a specific market, the manufacturer can legally place that device on that market.

I’m sure most of our readers are already familiar with the US Food and Drug Administration (FDA) regulations that apply to medical devices and with the Medical Device Regulation in Europe. However, the growth in the Chinese MedTech market means that medical device manufacturers need to start paying attention to the equivalent regulations in China. Can you tell us a bit about the regulations that apply to medical devices in China?

Before I speak about the actual regulations, I think it is worth knowing that in China, the National Medical Products Administration (NMPA) is responsible for the registration of medical devices for the Chinese market. The NMPA came into being in 2018 out of the restructuring of the former China Food and Drug Administration (CFDA). The restructuring is still going on and more than 300 standards regarding food and drug safety in China have been changed since the start of the restructuring. The ultimate goal of the restructuring is to create a more globalized approach to medical device certification.

Since there are changes taking place, which are the main regulations of the NMPA that manufacturers have to be aware of?

The main set of regulations that manufacturers have to be aware of is contained in the Regulations on Supervisory Management of Medical Devices. This is described in Order No.650. This is further supported and supplemented by many other orders, decrees and announcements which are still being issued as part of the restructuring of in the NMPA. There are also standards and guidelines. In addition, there are special regulations for foreign manufacturers, for software, for quality management, for classification, for medical device registration and for obtaining a CCC mark, which is required for some medical devices.

Some standards are comparable or even identical to those of ISO and IEC, but the majority have been modified or are completely different. Also, while previous revisions of international standards are commonly used, the latest international revisions are not recognized by the NMPA. A major obstacle for manufacturers is that not all standards and regulations are available in English.

Where can manufacturers access these regulations and standards?

There is a website listing all standards. It is important to remember that the standards are classified by prefixes. There are national and industry standards. There are two types of national standards. GB which indicates a binding/obligatory standard and GB/T which indicates a non-binding/recommended standard. There are also two types of industry standards. YY indicates a binding/obligatory standard for medicine and YY/T indicates a non-binding/recommended standard for medicine.

Would you take us through what a manufacturer needs to do in order to register a medical device in China?

Overall, there are different routes for registering a medical device in China based on whether you are a domestic manufacturer or a foreign manufacturer. But the first step is still to decide whether your device satisfies the NMPA definition of what is a medical device. If it satisfies the NMPA definition, then the next step is to determine the risk class, as with e.g. the MDR in the EU.

There are three risk classes in China:

  • Class I (medical devices with lower risks),
  • Class II and (medical devices with moderate risks),
  • Class III (medical devices with higher risks are categorized).

When evaluating the risks of a medical device, the manufacturer must take into account

  • the device’s intended use,
  • its structural features,
  • how it will be used,
  • as well as other relevant factors.

Thereafter, the specific requirements for each class apply. When the device is registered, it receives an NMPA certificate number which must be part of the labelling on the device. Thereafter, the device can be placed on the Chinese market.

The full process is summarised in a nice flow-chart that you can download.

ArrowFast Medical Device Registration Process in China

Can you describe how the Chinese medical device regulations compares to the EU MDR?

There are some things in common, e.g. similar requirements for foreign manufacturers, each device gets a unique device identifier, there is post-market surveillance to monitor the device after it has been released for use. There is also the requirement for a device master file containing all technical documentation.

As for the differences, the general approach and organizational structure differs. There is stricter overall control and a system of penalties. In addition, advertisement of the medical device shall be approved by the NMPA and there are strict requirements for operators (and users) of the medical device.

You’ve mentioned a few times that foreign manufacturers have special regulations that they must comply with. Can you explain a bit more about this?

Firstly, the medical device must be certified in the country of where the manufacturer has their registered place of business before the application for registration is submitted to the NMPA. Then, the foreign manufacturer must appoint a representative in China who is the agent for the device. The manufacturer must also ensure that after-sales service is provided for the device. In-country testing is also required for devices with risk Class II and III. However, clinical evaluation may be reused if it is compliant with NMPA Announcement No. 13 of 2018. All documentation must be submitted in Chinese and in the original language. However, a QMS audit is required only upon a decision of the technical evaluation institution, but there are no unannounced inspections.

Can you give us an idea of how long manufacturers can expect the registration process to take?

The average time from submission of application to receiving the registration certificate depends on the risk class. For Class I devices, it can take between 1 and 2 weeks, for Class II devices, it can take between 10 and 20 months and for Class III devices, it can take between 12 and 22 months. In the case that clinical trials are required, then there is an additional 1 to 2 years.

What do manufacturers have to do once the registration certificate has been granted?

Once the NMPA has issued the registration certificate, then the main responsibility of a domestic manufacturer or the China agent and after-sales service provider for a foreign manufacturer must register and maintain the data in the relevant Chinese databases, e.g. eRPS. Then, there are standard post-market related activities like surveillance and reporting, monitoring the product and issuing recalls, if necessary. Then there are change control activities and certificate renewal for Class II and III devices after they expire (currently 5 years). Basically, as for any medical device manufacturer, you have to pay constant attention to the device through its entire lifecycle.

Thank you, Matija. I’m sure that will be useful to our readers. How can readers get more information?

I tried to cover as much as I could, but of course there are many more details. So, if readers want more information then, they can contact the ArrowFast team at regulations@arrowfast.tech.

Remember, that readers can also download a simplified overview of what you need to do in order to get a medical device approved for use on the Chinese market.ArrowFast_Blog_Inline_Contact_us_with_logo

ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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