The official letter 3048/BYT-TB-CT Temporarily guiding extension the validity of registration numbers & deadline for submitting renewal registration dossiers of in-vitro diagnostic biologicals

The official letter 3048/BYT-TB-CT Temporarily guiding extension the validity of registration numbers & deadline for submitting renewal registration dossiers of in-vitro diagnostic biologicals

MINISTRY OF HEALTH		SOCIALIST REPUBLIC OF VIETNAM
		Independence – Freedom – Happiness
The official letter No.: 3048/BYT-TB-CT About: Temporarily guiding extension the validity of registration numbers & deadline for submitting renewal registration dossiers of in-vitro diagnostic biologicals
		Hanoi, 27 May, 2014

 

To: 

-          Provincial/municipal Departments of Health;

-          Applicants, manufacturers have IVD biological marketing in Vietnam.

According to Decision No. 1188/QD-BYT dated April 08, 2014 of the Ministry of Health regulated the functions, tasks, powers and organizational structure of Department of Medical Equipment and Construction (DMEC), IVD Biologicals will be transferred from DAV to DMEC for management consistent with the integration need of ASEAN and the world.

Currently, circulation registration of IVD biological conducted under the guidance in Circular No. 22/2009/TT-BYT dated November 24, 2009 regulates the registration of medicines. The Ministry of Health is conducting a review of the regulations of integration of medical devices of ASEAN and the world to build proper management document for IVD biologicals to ensure continuity, regulations.

Meantime, amendments to Circular 22/2009/TT-BYT and construction guidelines circulation registration of IVD biological under the due process, procedure promulgated legal documents and to promptly remove difficulties for Business now in the current period, meeting the production and business needs of applicants with IVD biological circulating in Vietnam, especially those with IVD biological winning bid to provide into medical facilities. The Ministry of Health informed temporary guideline for extending the validity of registration number, deadline for submitting renewal registration dossiers of IVD biological as follows:

I.          Extension the validity of registration numbers.

1.      The Ministry of Health will consider to extend the validity of registration numbers to IVD biological after the expiry date of registration numbers if it satisfies the following conditions:

a)      Have submitted renewal registration dossier at Ministry of Health before the expiry date of old registration number but not re-granted new registration number;

b)      Have winning bid notification of medical facilities before the expiry date of old registration numbers but not re-granted new registration number;

c)      Have dossiers request for extending the validity of registration number by applicants as prescribed in Clause 2, Section I of this official letter.

2.      Dossiers for requesting extension the validity of registration numbers including:

a)      Application to request for extension the validity of registration number and stating the reason.

b)      Origin or copy with duly notarized:

-          Winning bid notification within 6 months from the date of notification for the medical facilities organize 6 months/time bidding or within 1 year from the date of notification for the facilities organize 1 year/time bidding for IVD biological proposed extension the validity.

-          The contract for providing IVD biological to medical facilities for IVD biological proposed extension the validity.

3.      Extended duration and applied effect:

a)      Extended duration of the old registration numbers shall not exceed 6 months from the date Ministry of Health allows extension in writing. IVD biological permitted for manufacturing and importing within extended duration the validity of registration number must comply with the registration dossiers stored at Ministry of Health and allowed to circulate until the expiry date of IVD biological.

b)      The consideration for the extension the validity of registration numbers of IVD biological is applied until these contents of Circular No. 22/2009/TT-BYT be amended, supplemented or replaced.

II.    Submitting and evaluating the renewal dossiers:

-          The renewal dossiers to be submitted within 12 months before the expiry date of old registration number. In case, the renewal dossier meets the conditions for granting a new registration number before the expiry date of old registration number, the Ministry of Health will consider to grant new registration number after the expiry date of old registration number.

-          Ministry of Health notices the Provincial/municipal Departments of Health for implementation. In the implementation process, if any difficulties or problems arise, suggest Departments of Health or units promptly report to the Ministry of Health (Department of Medical Equipment and Construction) for review and resolution.

	HEALTH MINISTER
	(signed and stamped) NGUYEN THI KIM TIEN