Navigating technical documentation of medical device in global market
What is technical documentation?
What is technical documentation called in all markets of medical device?
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Technical documents
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Submission dossier
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Application dossier
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Technical file
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Technical dossier
Originally it is named Summary Technical Documentation by global harmonization task force. The organisation is now replaced by International Medical Device Regulators Forum (IMDRF).
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To understand technical documentation for all stakeholders in medical device, all should know it is for product registration (market authorization) submitted to regional authority or agency prepared by regulatory affairs manager and submitted oft by an authorised representative.
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From diverse views we can explain that technical document is
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A dossier to demonstrate safety, performance and effectiveness by authority to issue a certificate
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A bundle of documents which regulatory affairs manager daily work on (release, compilation, adopt to local requirements)
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A tip of iceberg of design history file at research and development department
It explains at ISO 13485
The medical device file shall include, not limited to
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Description of the device
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Specification of device
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Procedure for manufacturing, packaging, storage, handling and distribution
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Labelling
MDSAP:
Documented evidence normally an output of the quality management system (QMS), which
demonstrates compliance of a device to the regulatory requirements for products, and processes.
Technical documentation in global markets
How dose technical documentation look like?
Although IMDRF has suggested a Regulated Product Submissions Table of Contents for dossier of medical device and IVD, only a few countries recognise the practical table of content of technical document. This document provides an internationally harmonized, modular, format for use when filing medical device submissions to regulatory authorities for market authorization.
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So far Chinese authority NMPA has followed this guidance exemplary, with exact 6 main chapters and following.
Health Canada adapts also IMDRF ToC folder structure for medical device application.
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Why is technical documentation in each market different and difficult?
The overall development of technical documentation is simplified: from paper to electronic, risk based requirement per classificaton, detailed explanation for each technical documentation and clear review time after submission.
However exact against the purpose of IMDRF “minimizing regional divergences and indicating where regional variation exists” many countries has its own requirements:
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US: Using E-star FDA has given a modern electronic tool to fill the technical documents. There are requirements for documents and even an acceptance checklist
EU: So far familiar is requirement of technical documentation at annex II and III of MDR. Some notified bodies have provided suggested structure and checklist of technical documentation.
For global regulatory affairs manager getting products approved over the world, it is quite common that every authority has its different lists of technical documentation and emphasis to review technical documentation depending on product classification and type of registration.
The common chapters are
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risk management
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non-clinical evidence
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device description
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Quite different are
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market history
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labelling in regional language
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clinical evidence
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essential principle
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Post-Market Surveillance
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local testing
Some thoughts for an agile management of technical documentation
Technical documentation is not made by or for only regulatory affairs manager. It is a result of the whole company.
It is a fantasy that manufacturer of medical device has a common technical document fulfilling the global requirements.
However the global requirements of technical documentation can be analysed, traced and implemented as early as product release stage and even for verification in early design stage.
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Here are our suggestions of successful application on international markets:
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Monitor and analyse global regulations including standards
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Leaning eCTD of drug to numeric each technical document
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Using electronic tool internally for compiling the technical documentation
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Have a table of content, better electronic linkable to each document
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Provide a presentation, ideally face to face to authority how medical device works, new testing set up etc.
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Translate the deficiency by authority to R&D for reply and for optimization
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Make a project of roll out of international registration and integrate feedback to development of next generation product
Our appellation for authority:
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Clear structure and requirement of technical documentation
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Defined timeline to review dossier
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Publish good example of technical documentation
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Solid Q&A from best deficiency practise
Contact us for your global registration in every period. We know technical documentation from design & development, verification & Validation, transfer to production, at interface in quality management and how to compiled for international registration and most important for a compliance lifecycle of medical device and IVD.