What is change registration or licence amendment?
1. Background of change registration
The change registration can also be called re-registration or modification registration. It refers to an approved medical device upon significant change. Significant change is key part of design control of whole lifecycle of one medical device. It is the same as substantial change of medical device in US guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device”.
Upon significant change, manufacturer has to make from complex change registration to change notification to authority or file own change assessment depending on markets. Behind change registration in many markets it hides automatically that manufacturer has to wait for approval before implementing the change.
2. Two prominent examples China & Canada
Change registration in China
In China change registration is binding to obligatory Chinese standard, critical contents on product technical requirement (PTR), critical components, manufacturing sites, mechanism, intended use etc.
See Chinese significant change
The most complex change registration is changes triggering an update on PTR which means automatically type testing in China.
At Chinese change registration, change comparison is in the foreground. Normally the evidence as rational must be provided.
These documents are special for foreign manufacturer:
PTR change comparison
IFU change comparison
Summary of change
Statement of non-clinical research
Risk management file only including the changes
The review time is unchanged defined for class II and III medical device. However the real time of review at authority could be shorter. The cost of change registration is less than initial registration.
Attention
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There is no new product certificate in terms of change registration in China.
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Change notification should be used with original certificate.
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The validity of Chinese certificate is unchanged 5 years since initial product certificate.
Licence amendment in Canada
The typical significant changes triggering licence amendment is
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Changes to manufacturing processes
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Changes to facilities or equipment
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Changes to manufacturing quality control procedures
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Changes in design
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Changes to sterilization
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Changes to software
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Changes in materials for non in vitro diagnostic devices
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Changes in materials for in vitro diagnostic devices
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Changes to labelling
In this case manufacturer has to fill the same form of technical documentation as for a new medical device licence, plus Medical Device Licence Amendment Application Form. Licence amendment will indeed demand a whole new licence application altogether.
3. What else in other markets upon significant change?
EU
In EU upon significant change you have to notify notified body. The common guidance is MDCG 2020-03 “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”.
The advantage of European change notification is non-complex dossier needed and quick review time. Unfortunately there is no rule of cost and exact time for review depending decentralised NB.
US
In US upon substantial change of medical device manufacturer has to submit NEW premarket notification (510k) or NEW premarket approval. The content of submission dossier is wide however the focus is to compare to predicate devices which in this case is former approved own medical device.
Unique is after NEW 510k or PMA, the old own predicate devices if wished from manufacturer can be still marked.
Singapore
In Singapore there is official change notification form. It applies to Technical changes to Class C and D medical device and Review changes for Class B medical devices. Changes can only be implemented when the change notification application is approved. For critical technical change of class C and D medical device the review time rages from 75 to 90 working days.
Do you know that
• Effort for change registration is almost the same as initial registration
• Notified change in quality system is often ignored
• Software change in significant version should be also considered
• Changes should be bundled. The complicated change should be planned in next generation
Contact us for a kit of global significant change of medical device with templates or for joining our e-Learning or workshop.