I am looking at a class III in the US and Class D in Malaysia, non-electrical, non-medicinal, sterile, implantable device that is approved in the US. It currently has an approved shelf life of two years and real-time aging was completed to support the extension to change the shelf life from two to three years. There are no associated changes to the device materials or manufacturing processes to accommodate the shelf life extension, however the expiration date on the template for product labeling will be revised.
Would it be safe to say my assessment would be:
According to, “MDA/GD/0020 June 2018 Third Edition – Change Notification for Registered Medical Device,” the change in shelf-life expiration would be a Category 2 change that requires evaluation and endorsement from the MDA prior to implementation of the change and before placing in the market. This determination can be made after going through the changes that impact each of the categories and marking no for each of the categories that do not match. Table 1: Change notification for category 2 section 5.5.2c states, “All changes in specifications (including shelf life and stability) of a registered medical device,” in which the change in shelf-life expiration for device falls under. For this, a change notice would need to be submitted to Ministry of Health Malaysia. The change notice would be submitted with the following documents in order to be review and receive approval with the new shelf-life expiration:
Would it be safe to say my assessment would be:
According to, “MDA/GD/0020 June 2018 Third Edition – Change Notification for Registered Medical Device,” the change in shelf-life expiration would be a Category 2 change that requires evaluation and endorsement from the MDA prior to implementation of the change and before placing in the market. This determination can be made after going through the changes that impact each of the categories and marking no for each of the categories that do not match. Table 1: Change notification for category 2 section 5.5.2c states, “All changes in specifications (including shelf life and stability) of a registered medical device,” in which the change in shelf-life expiration for device falls under. For this, a change notice would need to be submitted to Ministry of Health Malaysia. The change notice would be submitted with the following documents in order to be review and receive approval with the new shelf-life expiration:
- Revised QMS certificate(s) (if applicable)
- Pre-clinical studies
- Risk analysis
- Clinical studies (if applicable)
- Medical Device labelling stating changes for each amended section (if applicable)
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