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Q

How do I punish a manufacturer who hid the side effects of a medical device?

FAQ LegalVistas39,818

A stock I recently invested in suddenly fluctuated wildly, which I thought was strange. Later, market manipulation was mentioned. I bought at that price and suffered losses. In this case, can I also view it as market manipulation and claim damages for Capital Markets Act violation? What conditions are needed for damages to actually be recognized?

medical device side effects

medical device act violation

medical device

A

Respuesta a la consulta relacionada

Yes, the case you mentioned may be a matter that can be reported as a violation of the Medical Devices Act.

This is because those who manufacture and sell medical devices have an obligation to accurately mark and explain the device's performance, efficacy, precautions for use, and side effects.

If they intentionally omit this or make false/exaggerated markings, they become subject to punishment for violation of the Medical Devices Act.

In particular, if they sold the device while concealing or not stating the possibility of side effects despite being aware of it, this constitutes a serious legal violation.

If they violate the Medical Devices Act, medical device manufacturers, etc. may be subject to administrative dispositions such as license revocation, along with imprisonment of up to 5 years or a fine of up to 50 million won.

If, like you, it actually causes harm to the human body such as skin damage, you can also pursue a damages (civil lawsuit) claim in parallel.

The medical device act violation report can be made through the Ministry of Food and Drug Safety website or the local food and drug administration office, Consumer 24, the National Petitions Center, etc.

It is also good to submit supporting materials such as damage photos, hospital diagnoses, and purchase details together.

The reporter's identity is protected, and reporting medical device adverse events is also possible by third parties, so do not hesitate to report through the formal procedure.

If necessary, please also consider consulting with an attorney to combine civil and criminal procedures.

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