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Procedures for Issuing New CFS for Group A Medical Devices

Procedure code name: CFS_C_LH_A
Procedure name: Issuing new certificate of free circulation (CFS) for group A medical equipment (TBYT) with circulation registration number

Implementation sequence

Step 1: Businesses submit applications through 2 methods:

Step 2:

  • Within 3 working days from the date of receiving the dossier, if the dossier is incomplete or not in accordance with regulations, the Department of Medical Equipment and Construction – Ministry of Health will notify the trader to supplement and complete it.

Step 3:

  • CFS issuance time is no more than 3 working days from the date of receipt of complete and correct documents from the trader.
  • In case of not granting CFS, the Ministry of Health will have a written response, stating the reasons.
  • The CFS issuing authority may conduct an inspection at the place of production if the dossier is not sufficiently substantiated or if it detects signs of violations related to the CFS issued previously.
  • Number of CFS issued according to request of trader/enterprise.

How to do it

  • Submit application online via public service portal system.

Profile components

  1. Document from the enterprise requesting a certificate of free circulation according to form No. 07 Appendix I attached to Circular 19/2021/TT-BYT.
  2. Certified copy of the certificate of conformity issued by a conformity assessment organization, which must be valid at the time of application.

Time limit for settlement

  • 5 working days.

Subject of implementation

  • Organization, business (trader).

Legal basis

  1. Circular 278/2016/TT-BTC : Regulations on collection rates, collection, payment, management and use of fees in the health sector.
  2. Decree 98/2021/ND-CP (November 8, 2021): Regulations on medical equipment management.

Fee

  • 1 million VND (fee for appraisal of export dossiers of medical equipment and supplies).

Implementing agency

  • Vietnam Ministry of Health.

Field

  • TBYT (Medical equipment) group A.

For advice on registration services for medical equipment, dietary supplements, cosmetics, and functional foods to ensure procedures comply with current regulations, please contact us at hotline 098.546.1894, email medgatevn@gmail.com or message via fanpage now for support.