PROCEDURES FOR GRANT OF A CERTIFICATE OF FREE SALE (CFS) FOR MEDICAL EQUIPMENT

 

In the current epidemic, there are many enterprises manufacturing medical equipment and having the demand to export their products. Thus, it is necessary for those enterprises to have Certificate of free sale (CFS) to export their medical equipment oversea.

In this following post, T2H Lawyers would like to provide information about procedures for registration of a Certificate of free sale (CFS) for medical equipment.

 

1.Prepare the dossier:

Pursuant to Article 11 of Decree No.69/2018/ND-CP about CFS for exported goods, the dossier must comprise:

  • An application for a CFS, stating the names and HS codes of goods, product standard certification numbers or registration numbers or standard codes (if any), composition and content of compounds (if any), and importing country: 1 original, expressed in Vietnamese and English.
  • The investment certificate or business registration certificate or enterprise registration certificate: 1 copy bearing the trader’s seal.
  • A list of manufacturing establishments (if any) with their names and addresses and goods manufactured for export: 1 original.
  • A list of declared applicable standards for products and goods, together with their expressions (on goods labels or packagings or documents accompanying the products and goods): 1 copy bearing the trader’s seal.

2.The execution of order:

Step 1: Prepare the dossier.

Step 2: Send 1 dossier set directly or via post office or online (if possible) to the Ministry of Health (the Department of Medical Device and Construction).

– The agency receiving dossier has responsibility to exam the dossier and shall issue a receipt or other written to the CFS applicant about one of these activities as follows:

– Receive the dossier if it is complete and valid.

– Return the dossier and request for supplementing documents if it is incomplete and invalid.

*Timeline: Within 05 working days from the receipt of valid dossier.

 

Contact T2H Lawyers for more information.

T2H Law Liability limited company

Head office: G4-4A, Dormitory 708, Lien Ninh, Thanh Tri, Hanoi

Branch office: Floor 4, no.2, 115 Chien Thang Street, Van Quan Ward, Ha Dong District, Hanoi.

Phone: 0242 242 9900 – 0989 656 682

Website: https://t2hlawyers.vn

Email: contact.t2h@t2h.vn – huong.le@t2h.vn

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