Translation of documents of medical device for registration purpose

Background

 

The translation of documents of medical device for registration purpose can be straightforward and also be complex. The next level of translation of documents is after many rounds correction, comments and sometimes by multi parties in a typical registration project from some months to 2 years.

 

We take the example of Chinese registration where Chinese documents are final version to submit to authority.

 

From simple to complex of translation

 

A. From subject language to Chinese and reverse

 

Normally it happens at beginning when the checklist of technical document is fixed. Given that at this moment there is no further revision of document, manufacturer can decide for a certified (ISO 17100:2015) translation office and translate the English technical documentation as risk management of medical device to Chinese.

 

As well if a final Chinese certificate or report is issued, the Chinese documents can be translated to subject language as English.

 

B. Translation after minor correction

 

It occurs that consulting party in Chine proves whether English documents are correct prior to translation, and they find something minor mistake.

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There are 2 options:

1. Revision of master document and translate it to Chinese one.

2. Consulting is 100% sure about wording. The original English document can be translated added with suggested Chinese wording. Manufacturer revise machine plus human translated and proved wording in master document.

 

C. Translation after major correction more than 3 revisions

 

The typical document is device description (DD) prior -, during - and after submission. Any time a revision might happen.

Imagine that you start with EN Rev1 DD to translate to CN Rev1 DD.

 

At least 2 revisions are needed, now the document has Rev 3. At deficiency stage by authority it might be another 2 revisions.

The question is that is it worthy to translate Chinese DD 4 times to English one.

The answer is absolute no. Manufacturer and consulting company should find a common way to

• Note all correction with comments and rational

• Decide for each correction with reasons

• Make the correction consolidated in a transparent format

 

Here are our experienced scenarios

1. Leave the reliable Chinese partner with rational to finalize Chinese document, at end translate it to English one.

2. Manufacturer should decide it for each action. So manufacturer define the final wording (functional und descriptive) and consulting or translation office translate these delta to Chinese documents. The prerequisite is to keep a master Chinese document from the beginning an.

3. It is possible to have bilingual document for the whole correction stages. At the end Chinese consulting uses only the Chinese texts.

 

Still for complex documents there are many questions open:

• How to make common correction consistent in the whole submission as intended use

• How to trace discussion of revision in email, meeting

• How to understand multi-comments in x years

• How to release only significant revisions

• How to note a change history in both languages

• How to reproduce lessons learned in next registration, if product-related actually how to integrate it in next development documents

 

 

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