Chinaʻs NMPA registration – what translations are required ?

Chinaʻs NMPA registration requires translating medical documents more than just the skills of professional Chinese translators. There are regulations and requirements that overseas companies need to know and must comply with to ensure they operate legally in the China market. Let us walk you through the fundamentals of registering a medical device and the translation requirements that you need to know.

Understanding China’s NMPA (National Medical Products Administration)

China National Medical Products Administration is the regulatory body in charge of medical devices, pharmaceuticals, and cosmetics that checks the safety of the products sold in the market, develops new technological breakthroughs and advancements, and manages the product standards and classifications systems.

This regulatory body also oversees devices registration, reviews marketing materials from the brands, and supervises inspections and registration. In a nutshell, if you are in the medical, pharmaceutical, healthcare, and cosmetics industries, NMPA is the first regulatory body you need to go to before launching your products and services. Moreover, NMPA requires companies to submit all required documents in Chinese and the source language.

Things You Need to Know About Translation and Registration on Medical and Pharmaceutical Products

Before the reformation of the regulatory body in China, registration and review on medical devices take months and years. Fortunately, the regulatory process as of this writing has improved, making it more efficient for foreign companies in the industries to introduce their products and services in the China market. However, no one is spared from the process and systems – follow the rules and the nitty-gritty stuff, your efforts will be rewarded.

Products Must Go to Safety and Effectiveness Tests and Submit Documents in Chinese

If you’re a manufacturer of medical devices, ensure that your products have gone through complete safety and effectiveness tests in your country. You must provide all the data where they are accurate and traceable. That said, in your research and development process, you must submit all documents and data as you apply to NMPA in Chinese, and use a professional Chinese Translation service provider.  You must translate all data into Simplified Chinese if your target audience is on Mainland. On top of that, you need to submit the documents in the original language. Ensure that the product or medical device is approved for public use in your home country.

For Drug Registrations, Medical Documents Must be Translated into Chinese

If you’re applying for a drug application, you also have to get NPMA’s approval on your product. Your application should be in Chinese, including supporting documents such as clinical trials, research, safety, efficacy. All these should be available in Chinese and the original language. NPMA will inspect the production site, clinical trials, non-clinical studies to verify if all the information you submit is accurate.

Chinaʻs NMPA registration: How Can LIMPID Help?

If you plan to expand in China market, you need to understand how NPMA works and its requirements for medical devices and drug applications. You can’t navigate the medical and pharmaceutical sector without a language and translation provider, especially before submitting applications and data. NPMA requires manufacturers to have all data and technical documents translated into Chinese. Fortunately, with LIMPID, our team has a decade of experience in helping manufacturers overseas. We have a team of professional medical translators, medical consultants, and legal advisors to help you have the right footing in China.