Headlines 21/01/2019 09:30 SA

Regulations on requirements concerning employees of medical equipment manufacturing facilities are repealed

Quý Tân

This is the highlight of the Decree No. 169/2018/ND-CP dated December 31, 2018 amending and supplementing the Decree No. 36/2016/ND-CP on management of medical equipment.

The Decree annuls regulations on employee requirements and amends regulations on professional manager requirements.

In addition, application for declaration of conformance to medical equipment manufacturing regulations will not include the followings:

Original copies or the certified true copies of documents evidencing conformance of a facility to regulations in clause 1, 2, 3 and 4 of Article 13 in the Decree 36.

At the same time, certain forms in Appendices to the Decree No. 39/2016, such as Form No. 10 and 11 of the Appendix I and Form No. 08 of the Appendix IV, will become invalid.

The Decree No. 169/2018/ND-CP will take effect on December 31, 2018.



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