Medical Devices Translation Service for the Chinese Market: A Comprehensive Guide

Recently updated on February 21st, 2024 at 08:36 pm

As medical devices manufacturers seek to expand their shares in global markets, the need for medical devices translation has grown at an unprecedented rate.

Here’re a few tips to help you start if you’re considering expanding into the Chinese medical devices sector.

What is the Medical Devices Industry?

The medical devices industry is one of the largest and most thriving fields in healthcare, science, and technology. This tremendously fast-growing sector develops and sells medical devices to healthcare institutions such as hospitals, doctors’ offices, and related firms. Their products include instruments, apparatuses or machines for treatment and diagnostics.

How Big is the Medical Devices Industry in China?

According to the U.S. Commercial Services, sales of medical devices began to soar in China in 2013, making it the second-largest market in the world. China is currently one of the world’s more promising markets for medical devices, and it’s a wise choice for businesses in the medical devices industry to expand into the Chinese market.

Understanding Medical Devices Regulations in China

The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the institution responsible for pharmaceuticals and medical devices regulations in China.

Similar to the FDA in the United States, the NMPA classifies medical devices into three classes (from I to III) depending on their potential risk. Class I devices are associated with the lowest risk, while Class III devices are associated with the highest risk.

Scope of Medical Devices Registration in China

In opposition to the European Union, China classifies medical devices into three classes:

• Class I – includes all devices whose safety and effectiveness can be ensured through routine administration.
• Class II – includes all devices that require further control to ensure their safety and effectiveness.
• Class III – includes devices that are used for life support or sustenance, pose a potential threat to patients’ health, and are implanted into the body.

💡If a medical device company wants to register a device that is not manufactured in China, it is required that the company provide device samples to the NMPA for testing. In the case of registering Class II and Class III devices, manufacturers are obligated to send the appropriate documents showing that the device has been approved in its country of origin (i.e. CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application). It may also be required to provide supportive clinical data along with the application. All product information on packaging and labelling must be translated to Simplified Chinese.

On October 31, 2017, the NMPA published a draft amendment to the Regulations on the Supervision and Administration of Medical Devices. On June 25, 2018, the NMPA published a revised draft amendment.

💡💡💡Medical device registration in China is now valid for 5 years (previously it was valid for only 4 years). If a manufacturer wants to renew a device’s registration, a renewal application should be submitted 6 months prior to the expiration date to the same department that received the original registration submission.

If you’re thinking about distributing medical devices to the Chinese market, you must be clear about the most important and up-to-date information regarding medical device regulations and the registration process in China.

Medical Device Name Registration in China

On 21 December 2015, China Food and Drug Administration (CFDA) issued the ‘The rule of setting medical device’s generic name’, which would be put into effect on 1 April 2016.

The purpose of this document is to regulate the generic name of the medical device to be sold in China, therefore the users can easily identify the functions of the device. It defines the key elements to form a medical device’s generic name in Chinese characters, and which words should not be used.

💡Selecting the appropriate Chinese generic name has now become a critical element in a regulatory strategy for medical device registration in China.

Medical Devices Translation Services by Chinese Copywriter

Chinese medical translation requires the highest linguistic quality and technical precision.

Our medical devices translation service delivers absolute precision and linguistic quality you can trust, allowing you to effectively manage global regulatory risk and confidently communicate with international customers, physicians, doctors, and patients around the world.

Medical Device Labels Translation

Together with the instructions for use, medical device labels must be translated to be regulation-compliant when the product is sold in international markets. The labeling documentation should show clearly where particular information will be provided and descriptive and information literature that companies the devices.

Medical Devices Software Localization

Modern medical devices increasingly use sophisticated software applications to manage and conduct advanced operations. This is why most medical device translation projects today involve some levels of software localization (or L10N), a process that extracts the software user interface (UI) strings into external resource files, translates the strings into the required languages, and recompiles them back into the localized application.

💡In addition to UI string translations, the translation service provider must perform linguistic validation or linguistic quality assurance (LQA) as well as functional and cosmetic testing to ensure the localized software is fully operational.

Types of Medical Device Documents We Translate

Chinese Copywriter provides comprehensive medical devices translation solutions for all types of medical device content, including design documents, manufacturing guides, operational instructions, compliance declaration, marketing, IFU, and customer training materials.

• IFUs (Instructions for Use)
• Medical devices Operation Manuals, Instruction and User Guides
• Product Catalogs
• Clinical Training Materials
• Brochures and web content
• Informed Consent Forms for clinical trials
• Localization of medical device software, translation of resource files

English-Chinese Glossary of Medical Device Terms

The following is a brief list of commonly used medical device terms.

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