Who has the authority to approve the usage standards for medical equipment?

To be specific:, Circular 08/2019/TT-BYT stipulates the issuance and approval of standards and norms for the use of specialized medical equipment under the authority of the following agencies:

- The authority to issue and approve standards and norms for the use of specialized medical equipment for public service providers in the healthcare sector under the management of Ministries, ministerial-level agencies, and provincial People’s Committees shall be implemented according to Point b, Clause 2, Article 8 of Decision 50/2017/QD-TTg.- The authority to approve and issue standards and norms for the use of specialized medical equipment for public service providers in the healthcare sector under the management of the Ministry of Health:

- The head of the public service provider that ensures regular and investment expenses issues and approves the standards and norms for the use of machinery and specialized equipment in the healthcare sector of their unit, except for the cases stipulated in Clause 3, Article 6 of Circular 08;- The Minister of Health approves or decentralizes the authority to approve the standards and norms for the use of machinery and specialized equipment in the healthcare sector for public service providers under the Ministry of Health that are not covered by the above provision or have a requirement for the use of specialized medical equipment exceeding the standards and norms.

For details, see Circular 08/2019/TT-BYT, effective from August 1, 2019.

- Thanh Lam -

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