Subcontractor or oursourced partner of medical device
Background in regulatory view
Subcontractor is also called outsourced partner in medical device field. It could be for components, finished products, design and development, software development, sterilisation or even testing and production.
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The prominent regulation is Purchasing section (7.4) at ISO 13485:2016. We will not explain how to make supplier selection matrix but underscore regulatory review of critical subcontractor of medical device.
We would also include internal outsourcing in different sites as production in this article, because due to different markets` legislative even for the same medical device produced it could be transferable difficult.
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Regulatory requirements of subcontractor
From regulatory requirements, the information on site of subcontractor plays an unpredictable role at product- and QM registration of medical device. It means that it is more market specific than a common issue. The trouble is that manufacturer needs time and effort to collect different information from subcontractor at critical deficiency reply at product registration. So the regulatory requirements in trend should be integrated in technical documentation through design transfer at legal manufacturer.
The first role under subcontractor is for sure contract manufacturer. Summarised regulatory requirements of subcontractor can be categorised as:
-At product registration, many verification and validation reports are derived from subcontractor of critical components and at critical process owner (cleaning room validation).
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In chapter 6 of technical documentation at IMDRF (In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) is typical for production elements not only for legal manufacturer but also for contract manufacturer.
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Chapter 6A Quality Management System Procedures
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Chapter 6B Quality Management System Device Specific information
-At quality management system maintenance, info as valid ISO 13485, layout of production, workflow of production, QM documents are elementary to update every few years.
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-At FDA in US and at authority MHLW in Japan, contract manufacturer has to register his entity regularly. For FDA even the listing of entity applies also to Contract Sterilizer, Relabeler or Repackager, Remanufacturer, Reprocessor and Specification Developer.
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-Under frame of certification of ISO 13485 at legal manufacturers, all critical subcontractors can be audited.
Product - and Quality management system controlling
To qualify as critical subcontractor is to have either ISO 13485 or ISO 9001. The legal manufacturers have normally regulator inspection. It is tricky if subcontractor stays in another market with local good manufacturing practise and has to fulfil at the same time international ISO 13485 or home countries QM requirements of legal manufacturers.
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Here are typical inspections items in terms of quality management
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Management review
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Internal audit
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Non-conforming products
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CAPA
Here are typical inspection items in terms of medical device
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Design - or production records
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Risk management
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Design transfer record of each LOT or Serial
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Design control
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(Re)-Validation
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Control of critical material and component
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As we are regulatory experts, the follows documents are missing often for global registration
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Info of significant change (as change of manufacturing site and critical material) with details
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Verification of critical components
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Layout of production site
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IQ, OQ and PQ of critical process
Labelling makes always trouble
In general legal manufacturer should provide hint how to place label and instruction for use (IFU) on finished products or legal manufacturer does it in his own logistic by placing labelling by himself.
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Depending on where products are approved, labelling is not only language specific but also market diverse. So far there is no general guidance in any market how to bring info of subcontractor on labelling. Classic is to have contract manufacturer on IFU at least. There is in Vietnam item “made in X” (country of origin). However there is no definition how to decide made in (confusing between longest supply chain, final inspection or legal manufacturer).
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For components it has also no rules. Normally if components of medical device need to have international wireless certificate, the certification number and symbol of wireless organisation must be on the components.
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Contract is basis
Contractor of supplier is also called quality agreement. This is most controlled documents by notified body at MDR in EU. Manufacturers should update contract with subcontractor regularly updating state of the art requirements of regulations and medical device.
Legal manufacturer might make a renewal process system of contract with subcontractors as experienced by different authorities for medical device. It means that subcontractor has to fill the records and update critical QM documents every x years.
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Trend of outsourced production or design
One of the rising trend is that legal manufacturer add, remove, update with his own or third party production. It is cost saving, risk distribution due to more productions and beneficial from other specialised expertise.
Wherever production is outsourced, the legal manufacturer has liability of finished medical device and should keep all medical device file in design and production. In the most cases subcontractor has no right or technical documentation to mart the product globally.
Very interestingly legal manufacturer (also called Own Brand labelling or private label manufacturer) and contract manufacturer can in Canada register separately the same medical device which is unusual in other markets.
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Outlook
Contact us if you want us to be interim manager to audit your critical subcontractor or register contract manufactured medical device over the world.
Even if you are new as subcontractor, we can make a gap analysis of your international partnership with legal manufacturer of medical device.