TRANSLATION BY INDUSTRY · MEDICAL & PHARMACEUTICAL
Medical, Pharmaceutical & Life Sciences Translation Services in 40+ Languages
Medical and pharmaceutical translation covers patient records and consent, medical device documentation, pharmaceutical regulatory dossiers, clinical trial materials, and medical certificates — for healthcare providers, device manufacturers, pharmaceutical companies, and individuals worldwide. For companies bringing a product into the China market specifically, HI-COM’s process is built around the actual regulatory mechanism — NMPA device-risk classification and CDE drug-dossier review — not just general medical terminology.
ISO 17100 certified
TAC member
40+ languagesWhich Translation Service Do You Need?
Four related HI-COM services, split by document type so you land on the right specialists the first time.
Medical Records, Consent & Patient Data
Patient records, informed consent forms, and medical report translation for healthcare providers, insurers, or employers — wherever the receiving party sits. Documentation tied to a specific country’s data-handling requirements (China’s included) is scoped and handled to that jurisdiction’s own rules, confirmed with you at project setup rather than assumed generically.
Medical Device Registration — By NMPA Risk Class
Medical devices sold in China are classified by NMPA (National Medical Products Administration) into three risk classes, and the documentation you need translated depends on which class your device falls into.
| Class | Risk Level | Examples | Pathway | Review Time |
|---|---|---|---|---|
| Class I | Low-risk | Stethoscopes, bandages, wheelchairs | Device filing | ~5 working days |
| Class II | Moderate-risk | ECG machines, hearing aids, blood pressure monitors | Full NMPA registration | ~60 working days |
| Class III | High-risk / implantable | Contact lens solutions, X-ray machines, prosthetic joints | Full NMPA registration | ~90 working days |
Classification is based on intended use and clinical function, not the product’s name or category assumption — getting this wrong early is a common, costly cause of delay. Documentation scales with class: Class I needs basic safety/quality documentation and no clinical trials; Class II requires mandatory type testing plus detailed technical documentation; Class III requires comprehensive clinical evaluation reports and potentially local clinical trials in China.
Operational guidance, not regulatory sign-off — confirm current classification requirements with your regulatory affairs team.
Pharmaceutical & Regulatory Dossier Translation
Pharmaceutical submissions typically follow CTD (Common Technical Document) format — the ICH-standardized structure used across multiple international regulators, not a China-only requirement. For China specifically, that means marketing-authorization-holder documentation, drug labeling, and CDE (Center for Drug Evaluation)-facing submission materials.
Terminology consistency across a multi-document dossier matters more here than in almost any other document type — a term translated two different ways across a submission is a real review risk, not just a style issue.
Operational guidance, not legal or regulatory advice — confirm current CDE submission requirements with qualified regulatory counsel.
Clinical Trial Documentation
Clinical trial protocols, informed consent forms, case report forms, and investigator communications, translated with GCP (Good Clinical Practice) terminology consistency in mind — GCP is an international standard, so this applies whether the trial site is in China or anywhere else.
Medical Certificates & Individual Documents
Medical certificates, fitness-for-work documentation, and insurance-related medical reports for employees, expatriates, and individuals dealing with healthcare providers, employers, or insurers anywhere — not limited to China-bound documents. Many of these documents need official recognition, not just accurate translation — see Sworn & Certified Translation for how that mechanism varies by receiving country (China, Europe, the Americas and Australia).
Not Sure Which Class Your Device Falls Into?
Tell us what the device does and its intended use, and we’ll help you understand which NMPA class it’s likely to fall into and what documentation that means for translation scope — as part of your quote conversation, before you commit to anything.
Discuss My Device’s ClassificationWhy Naming the Regulator (and the Class) Matters
Several medical translation providers mention NMPA or CDE in general terms without going further — describing “regulatory translation” without explaining what actually changes between a Class I filing and a Class III submission. If a provider’s medical translation content doesn’t get more specific than naming the regulator, it’s worth asking whether they understand the registration process or are translating generically around it. HI-COM’s approach starts with classification, because that’s what actually determines the scope of translation work.
Credentials
HI-COM is ISO 17100 certified and a member of the Translators Association of China (TAC).
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Frequently Asked Questions
Do you translate documents for NMPA medical device registration?
Yes — device registration dossiers, technical files, clinical evaluation reports, and labeling/instructions for use, scoped to your device’s NMPA risk class (Class I, II, or III) and translated/formatted for submission requirements.
What’s the difference between NMPA and CDE?
NMPA (National Medical Products Administration) is China’s overall medical products regulator; CDE (Center for Drug Evaluation) sits under it and specifically reviews drug submissions. Device registrations go through NMPA classification and review; drug/pharmaceutical dossiers go through CDE review as part of the NMPA framework.
How do I know which NMPA class my device falls into?
Classification depends on intended use and clinical function, not the product category or name. Low-risk devices like stethoscopes or bandages are Class I; moderate-risk devices with electrical or monitoring functions like ECG machines are Class II; high-risk, implantable, or life-sustaining devices like prosthetic joints are Class III. Tell us what your device does and we can help you understand which class applies and what that means for translation scope.
Can you translate clinical trial protocols and consent forms?
Yes, with GCP terminology consistency maintained across the full document set — protocol, consent forms, case report forms, and investigator communications, for trial sites anywhere, not only in China.
Do you handle medical certificates for individuals, not just companies?
Yes — medical certificates, fitness-for-work documentation, and insurance-related medical reports for individuals, including expatriates. Where a document needs official recognition rather than just accurate translation, see Sworn & Certified Translation for how that mechanism varies by receiving country.
How long does NMPA review take once documents are translated?
Roughly 5 working days for Class I filings, 60 working days for Class II, and 90 working days for Class III — that’s NMPA’s own review timeline, not HI-COM’s translation turnaround, which is separate and confirmed as part of your quote.
Related Services
Ready to Send Your Medical or Pharmaceutical Document?
Send your document, or a sample page, and HI-COM will confirm the right approach — and, for China-bound devices, help you confirm the NMPA class first.
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