China Medical Device Regulations

General considerations of medical device regulations in China

The National Medical Products Administration (NMPA, previously CFDA) is the responsible body for the regulation of medical devices and drugs in China.

China classifies medical devices into three classes according to the China medical device regulations:

• China medical device regulations – Class I, which includes all devices whose safety and effectiveness can be ensured through routine administration. This includes products such as enema kits or elastic bandages.
• China medical device regulations – Class II, which includes all devices that would require some control to ensure their safety and effectiveness. Examples of such devices would be CT scanners or infusion pumps for intravenous medications.
• China medical device regulations – Class III, which includes devices that would pose life-threatening or serious health issues if they were not controlled effectively, or devices that are implanted into the body. This would include products such as deep brain stimulators or pacemakers.

What should I know as an overseas manufacturer registering a medical device in China?

Previously, registering for the medical device regulations in China was only valid for four years. Now the term of registration is five years and is only necessary for class II and class III devices. Class I devices are required to be filed but they are not required to be registered.

The device must have samples submitted to the NMPA for analysis. Class II and III devices also require records providing the device has been approved in its original country. Additionally, all product labelling must be translated into Chinese, including labelling and packaging for the China regulations for medical devices. Foreign manufacturers may also be required to send additional data from clinical trials when registering their Class II and Class III medical devices.

Overseas manufacturers must hire a China-based agent to register products outside of China. The agent should provide maintenance support and technical service and should oversee the registration and clinical trial process. The agent would also be responsible for managing and adverse events in case of device malfunction or recall.

Want to learn more about medical device compliance? Read all about ‘instructions for use medical device‘ and learn about the ‘MDR legal manufacturer definition‘.

Updates to the China medical device regulations on the Supervision and Administration of Medical Devices in 2021

On 18 March 2021, the State Council of China announced the 2021 Amendment to the Medical Device Regulation in China. This took effect on 1 June 2021 and was the third amendment to the Medical Device Regulation since 2000. The amendment was widely recognised as progressive and reflective of the advancement and innovations in the industry. So, what does it entail?

• Fast-track approvals: The amendment contains an exemption for certain innovative medical devices that are manufactured overseas to be registered with the NMPA to not require a marketing authorisation in their home country. The NMPA can now grant special or conditional approval for the use of certain unregistered medical devices to counter public health emergencies or any rare, life-threatening illnesses that do not have an effective treatment.
• Reform in clinical evaluation: Clinical evaluation can be achieved through clinical trials or desktop evaluation. Prior to the Amendment, only a certain group of medical devices could be exempted from clinical trials but would still remain subject to desktop evaluation. The Amendment also confirms that patients suffering from life-threatening diseases without effective treatment can participate in clinical trials of a medical device, and such data can be used for applying for registration of the medical device.
• Streamlined process: The Amendment also streamlined several aspects of the medical device registration process including:
• An applicant of Class II and Class III medical devices may choose to perform the testing and prepare the testing reports through self-sourced testing centres as an alternative to testing done by NMPA testing centres
• A distributor of Class II medical devices may be exempted from record-filing in certain circumstances
• A clinical trial application could be approved by the NMPA if the NMPA doesn’t respond within the official review period of 60 working days
• The overall review time for manufacturing and distribution of license applications has been reduced to 20 working days (originally 30).
• Enhanced penal system: The amendment also added new categories of prohibited or restricted activities and increased penalties over matters such as providing false or misleading application documents or failure to perform quality assurance obligations. For example, the ceiling for monetary fines for operating without a license has been increased from 10 to 30 times the value of the product in question.

While the amendment reflects the deepened reform in the medical industry in China and encourages innovation while balancing medical needs, it also provides an opportunity for market entry for foreign manufacturers.

When considering placing a medical device on the Chinese marketplace, it is imperative to ensure that you know the classification of your product firstly and can take the necessary steps towards ensuring your product meets the correct requirements for certification for the Chinese marketplace. Keep in mind it differs from the European CE Marking for Medical Devices.