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Malaysia: don’t get caught out by registration submission extension

This article was originally published in Clinica

Executive Summary

Malaysia’s one-year extension of its 30 June 2015 deadline for companies with medical devices on the market to register their products under the country’s new regulatory system may come as welcomed breathing space for industry, but manufacturers and distributors must not see this as an excuse to delay filing their submissions with the Malaysian Medical Device Authority. This is because companies that have not submitted their applications, nor paid their registration fee to the regulator, as of 1 July, are technically selling their products in Malaysia illegally.

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