Đang gửi...

HOW TO RE-ISSUE THE REGISTRATION NUMBER FOR DAMAGED MEDICAL EQUIPMENT?

When the Certificate of Sale is lost or damaged, the free-sale registration number must be reissued. The following article will explain the legal requirements for reissuing a medical equipment registration number.

Legal basis:

- Law on Investment 2020;

- Decree 36/2016/ND-CP on medical equipment management.

1. Reissue of circulation registration number dossier:

- A written request for the circulation number to be reissued

2. Acceptance and evaluation of an application for a medical equipment free-sale registration number

- A dossier must be submitted to the Ministry of Health by the business requesting the issuing of a free-sale registration number.

- The Ministry of Health will give a certificate of receipt for the application for a free-sale registration number to the applicant upon receipt of a complete and valid application.

- If no request to revise or augment the dossier is received, the Minister of Health is responsible for the following:

Within 05 working days of the date mentioned on the application receipt, a new circulation number will be issued. In the event that the free-sale registration number is not re-granted, the cause must be stated in writing.

- If the free-sale registration number application file is incomplete, the Ministry of Health must send a written notice to the establishment requesting the re-issuance of a free-sale registration number to supplement or amend the dossier, specifying the following: which documents and contents must be amended within the time limit:

The application for re-issuance of the free-sale registration number must be submitted within five working days of the date specified on the application receipt.

- When the establishment requesting the issuance of a free-sale registration number receives a written request for supplementation or modification of the application file for a free-sale registration number, it must supplement and amend it according to the contents recorded in the document and send it to the applicant. Ministry of Health and Human Services.

If a business asking for a free-sale registration number has added or updated its dossier but it does not meet the requirements, the Ministry of Health will advise the firm to finish the dossier.

If the establishment does not supplement or amend the dossier after 90 days from the date of the Ministry of Health's written request, or after 05 times of amending and supplementing the dossier from the date of the Ministry of Health's request for amendment, If the dossier is supplemented for the first time but still does not match the standards, the application for a free-sale registration number must be started over.

- If the assessment council requires that the dossier be amended and supplemented, the Ministry of Health must provide a written notice to the seeking entity within 10 working days after receiving the minutes of the council meeting. circulation to augment records The written notice must state which papers have been supplemented and whose information has been changed.

When the applicant for a free-sale registration number receives a written request for supplementation or modification of the registration file for free sale, the applicant must supplement or edit it in line with the contents of the document and send it to the Ministry of Health. On the application reception, the date of receipt of the supplemented or updated dossier is noted.

If a business asking for a free-sale registration number has added or updated its dossier but it does not meet the requirements, the Ministry of Health will advise the firm to finish the dossier.

 

The above information is about the " How to re-issue the registration number for damaged medical equipment?". For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 - (024) 6293 8326

Email: contact@luatdoanhtri.vn

Doanh Tri Law Firm is pleased to accompany our Customers!

Contact Us