ベトナム 新医療機器規制の移行期間に対する正式通知を本日発表 - クアルテックジャパンコンサルティング株式会社

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ベトナム 新医療機器規制の移行期間に対する正式通知を本日発表

カテゴリ: ベトナム 作成日:2020年01月08日(水)

本日付、べトナムMoHはDecree 36 & 169 に対する移行期間の設定を正式に発表いたしました。

 
1 For class A medical device, there is a receipt note for applicable standard declaration issued by the Department of Health, which is imported according to demand without quantity restriction and without the confirmation letter from MOH to confirm it is medical device prior customs declaration procedures.
2 For medical devices excluded in the list of goods of Circular 30 that classified as class B, C, and D medical device by the organizations which was published into the electronic portal by MOH will continue to be imported until December 31, 2021 on demand, without any quantity restriction and confirmation letter from MOH.
3 Class B, C and D medical devices that are specifically listed out in Circular 30 must be applied Import Permit until Dec 31,2021 and the Import License will be effective until Dec 31, 2021.
4 Import licenses for class B, C and D medical device expired on December 31, 2018 or Dec 31, 2019 are valid automatically until December 31, 2021.
5 MOH began to receive registration application for all class B, C, and D imported medical devices from July 1, 2017 and the registration number for class B, C, D will be valid from Jan 1, 2022.
6 MOH began to receive registration application for all class B, C, and D imported medical devices from July 1, 2017 and the registration number for class B, C, D will be valid from Jan 1, 2022.
7 CSDT will be effective from Jan 1st 2022.
注意           上記は原文の参考訳となります。

 

 

<原文>

https://dmec.moh.gov.vn/documents/10182/10030594/Nghidinhso032020/ac619899-3566-42e3-9f83-fdbeb615f490