New regulation on import of medical device into Vietnam

New regulation on import of medical device into Vietnam

On 15 May 2016, the Vietnamese Government issued new regulation on import of medical device into Vietnam, Decree No. 36/2016/ND-CP on medical device management. The new regulation on import of medical device into Vietnam took effect on 1 July 2016, bring medical devices under uniform management.

Previously, medical devices imported into Vietnam were required to obtain import license from Department of Medical Equipment and Health Works under the Ministry of Health.

According to the new regulation on import of medical device into Vietnam, foreign medical devices no longer require import license but must be registered with and obtain Marketing Authorization licenses from Department of Medical Equipment and Health Works under the Ministry of Health before being imported and circulated in Vietnam. The Decree set forth a transitional period of 6 months to 1 year for implementation.

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Lawyer VN - Vietnamese Law Firm