PMDA, NMPA, and MFDS: A Guide to Translation Requirements for Asian Regulatory Submissions

Asia-Pacific is the fastest-growing medical device market in the world. But each market has unique translation requirements — and mistakes cost time and money.

Why Asia Matters for Medical Device Companies

• Japan: Second-largest medical device market after USA. Aging population drives demand.
• China: Fastest-growing market. Regulatory reforms accelerating approvals.
• South Korea: Innovation hub with demanding regulators and tech-savvy patients.
• ASEAN: 650M population, harmonizing regulations across 11 countries.

But here's the catch: translation isn't optional, and sloppy translation costs you 6–12 months in delays.

Japan (PMDA): The Gold Standard Market

Requirements

• Language: All submissions must be in Japanese
• Format: STED (Summary, Technology, Education, Data) for significant devices
• Terminology: PMDA has published guidance documents with preferred terminology
• Clinical data: Japanese clinical data preferred; translated clinical summaries must match PMDA style

Common Pitfalls

• Using general Japanese instead of medical Japanese — PMDA reviewers expect technical terminology
• Inconsistent terminology across the submission package (IFU uses term A, summary uses term B)
• Literal translations that don't match PMDA's published guidance (available free on PMDA website)
• Using Simplified Chinese terminologies for Japanese devices (common mistake)

Timeline

Translation + review: 3–4 weeks (if using a specialized medical translator)
PMDA review: 6–12 months (depending on device risk class)

China (NMPA): Rapid Reform, New Opportunities

Requirements

• Language: Simplified Chinese (not Traditional Chinese from Taiwan)
• Regulatory path: MAH (Marketing Authorization Holder) system — can use Chinese distributors
• Clinical data: Recent reforms allow use of international clinical data if Chinese clinical trial isn't needed
• Terminology: GB (Guobiao — national standard) terminology preferred; NMPA has published medical device glossaries

Common Pitfalls

• Simplified vs. Traditional Chinese: Using Traditional Chinese causes outright rejection. This is NOT a subtle issue.
• Machine translation: Many companies use Google Translate or ChatGPT for Chinese. Regulatory agencies notice and delays result.
• Outdated terminology: NMPA updates its terminology glossaries regularly. Using old terms delays approval.
• Missing in-China clinical data: Even with MAH reforms, some device classes still require Chinese clinical trials. Translation of trial protocols is critical.

Timeline

Translation: 2–3 weeks
NMPA review: 4–9 months (accelerated review available)
Clinical trial (if required): 12–24 months

South Korea (MFDS): High Standards

Requirements

• Language: Korean
• Nomenclature: KGMP (Korean Good Manufacturing Practice) — more stringent than many other markets
• IFU: Must be in Korean even for export-only devices (if marketed in Korea)
• Quality documentation: Technical files must reference Korean standards

Common Pitfalls

• Underestimating MFDS rigor — regulatory standard is very high
• Using casual or colloquial Korean in technical documents
• Not accounting for Korean-specific manufacturing and quality standards

Timeline

Translation: 2–3 weeks
MFDS review: 3–6 months

ASEAN Markets (Thailand, Indonesia, Vietnam, Malaysia)

The Opportunity

• ASEAN Medical Device Directive (AMDD) harmonizing regulations
• Easier approval pathways for Class I/II devices
• Growing middle class driving demand

Translation Complexity

• Thailand: Thai language required; limited translator pool
• Indonesia: Bahasa Indonesia (distinct from Malay); many translators available but quality varies
• Vietnam: Vietnamese language; French terminology legacy in medical field
• Malaysia: Malay or English accepted; English easier but Malay preferred for preference

Best Practices Across All Markets

1. Use regulatory-specific terminology databases. Don't rely on translators' general knowledge. PMDA, NMPA, MFDS have published guidance documents.
2. Build translation memory early. Your first device needs custom terminology work; your second device reuses 60–70% of segments.
3. Review translated documents in context. A segment is correct in Japanese but wrong in the context of your device class. Have medical reviewers (not just linguists) sign off.
4. Budget for back-translation. Regulatory authorities sometimes ask: "Is this translation accurate?" Back-translation by independent linguists provides confidence.
5. Plan translation early. Don't let translation be your critical path. Start during clinical trial planning, not at regulatory submission.

How ComplyLingo Solves This

ComplyLingo maintains curated regulatory terminology databases for PMDA, NMPA, MFDS, Thai FDA, and ASEAN. Every translation is validated against these databases automatically.

Plus:

• Translation memory grows across all your projects
• Confidence scoring flags low-confidence segments
• Back-translation available as an add-on
• Audit trail sufficient for regulatory submissions

Ready to navigate Asian regulatory submissions with confidence?

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