Establishment of association operating in the field of medical device Service

Establishment of association operating in the field of medical device Service

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We understand that you are seeking legal assistance on the establishment of association operating in the field of medical device (the “Association”). We therefore are grateful to present you our Legal Services Proposal for your review and consideration.

  1. Overview

1.1. Conditions for establishing an association

To establish an association operating in Hanoi, you must note these following conditions:

  • The association operates for purposes not contrary to law. Its name and main activity are not identical with those of associations which have been lawfully established earlier in the same locality;
  • It has a charter;
  • It has a head office;
  • For a provincial association, at least 50 citizens and/or institutions in the province meeting membership criteria and filing an application to voluntarily join and establish the association. For a professional association of particular specialty, the minimum number of citizens and institutions voluntarily joining and establishing the association shall be considered and decided on a case-by-case basis by competent state agencies.

1.2.      Procedure of association establishment

To establish association operating in the field of medical device, you need to undertake three steps of procedure as follows:

Step 1: Apply for recognition of Boards to campaign for the establishment of associations to Hanoi Health Department. The application includes:

  • An application form for recognition of a campaigning board,
  • A list and resumes of expected board members, indicating their full names, dales of birth, places of residence; educational levels; and professional qualifications.

Expected working time: 60 working days

Step 2: Apply for  association establishment to Hanoi Department of Home Affairs. The application shall include:

  • An application form to establish the association;
  • Draft association charter;
  • List of members of the campaigning board recognized by a competent state agency.
  • Plan of operation
  • Judicial record of the campaigning board’s head
  • Written certification of the association’s planned head office
  • Statement of assets voluntarily contributed by members (if any).

Expected working time: 60 working days

Step 3: Hold congresses to establish associations. Within 90 days from the effective date of the decision to license the establishment of an association, the campaigning board shall hold a congress to establish the association.

Past this time limit, if the congress is not held, within 15 days after the deadline set as prescribed by law, the campaigning board shall send a written request to extend the time to hold such congress to the state agency which has licensed the association establishment. The extended time must not exceed 30 days. Past this time limit, if the congress is not held, the decision to license the association establishment ceases to be effective.

Note: For avoidance of any doubt, in practice, the administrative procedures may take longer than expected since the competent authority must consult relevant ministries before granting the license. In such a case, SB Law shall try our best to accelerate the progress in order to obtain the approvals at the earliest as possible.

  1. Scope of works and performance time:

2.1. Scope of works

Scope of works
Preparation of the application documents:

·       Notifying application documents required in accordance with Vietnamese law;

·       Drafting application documents required

·       Liaising with you to discuss the draft application documents;

·       Amending the application documents based on your comments;

Licensing procedures:

·       Submitting the application dossier to the licensing authority on your behalf;

·       Monitoring and following up with the relevant authorities on the approval process;

·       Keeping you updated on the developments and additional requirements, if any

2.2. Performance time:

a. Preparing the application dossier :

We shall collect necessary information and documents from you. Upon receipt of necessary information and documents from you, we shall prepare the application dossier under the standard forms, includes: (i) Application for recognition of Boards to campaign for the establishment of associations; (ii) Application for association establishment

The initial drafted application dossier shall be sent to you for your comments. Then, after updating the application dossier based on your comments, we shall obtain the preliminary comments from the competent authority and send the finalized application dossiers for you to sign and seal. We anticipate that this phase shall be completed within 10 working days from the date on which we receive fully necessary information and documents from you

b. Licensing procedure

Within 02 working days from receipt of duly signed and sealed application dossier, we shall submit the application dossier to the competent authority.

  1. Professional fee and payment

3.1. Professional fee

The Professional fee for performing the SB Law services as mentioned in item 2 above will be VND 250,000,000 (in words: Two hundred fifty million dong)

This cost does not include VAT (10%), travel and accommodation expenses in case the Client requests SB Law to perform work outside of Hanoi, Ho Chi Minh City, and other costs incurred on behalf of the Customer (if any).

3.2. Payment

Services fee shall be paid to SB Law as follows:

  • Within 05 working days from the date of signing the legal service contract, Client will pay for SB Law an advance payment which equivalent to 70% of the total estimated services fee, including VAT.
  • Client will pay the remained fee and other cost and disbursement incurred on Client’s behalf within 05 working days from SB Law completed its works.

Client shall immediately notify SB Law of when actual payment(s) will be made on the amount specified in the invoice(s). SB Law will start working only upon receipt of payment of the respective invoice(s). Alternatively, SB Law reserves the right to withdraw the service if payment is not received 10 days after the date of the invoice. Further, in the event payments are not received by the payable date, SB Law reserves the right to suspend services and/or levy and collect a late payment fee of 0.5% per month up to the date of receipt of payment by SB Law.