When you've determined there is a need for recall. you would do a health risk assessment to know the depth of recall - how many units affected and where they've been distributed. If the affected units are in US and one/more OUS countries, you would have to initiate the recall in all these countries. The burden to initiate and implement the recall is always on the manufacturer. Voluntary recall is expected and it is never a good idea to let the regulatory authorities figure it out. I know it is voluntary in the US, can't imagine it being different in other countries.
I don't see why you would need to report a product recall through the in country recall reporting procedure (like 21 CFR 7 for US, if the products sold in that country are not affected. You have to summarize such details in documents like CER, PSURs (for MDR) for EU, even if EU distributed products were not affected.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 31-May-2018 09:23
From: Toru Murakumo
Subject: Recall in other countries
I have a question about recall of IVD product in foreign countries.
Your product is sold in your own country as well as many countries such as US, EU and China. When you decide a recall for the product, you may notify the recall to your distributors in all the countries. In that case, do you insist to recall all the distributors? Or do you leave the recall decision to the distributors according to the regulations in their countries? If you leave the decision to them, some countries may initiate recall and some may not. Do you accept such a situation? The regulatory authorities communicate each other and they will know the situation sooner or later. Do the authorities also understand and accept such a situation?
I would appreciate it if you would share your knowledge and experience.
Best regards,
Toru
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Toru Murakumo RAC
General Manager, QA & RA
LSI Medience Corporation
Tokyo, Japan
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