Tunisia Country Overview

MD24 S.r.l.
Via Saragat 5 - 40026 – Imola – BO – (Italia)
 +39 0542 1892624
 +39 0542 641833
 www.md-24.net
 [email protected]
REGISTRATION OF MEDICAL DEVICES TO THE
MINISTRY OF HEALTH OF TUNISIA
disclaimer
(http://www.dpm.tn/)
The information provided in this protocol is current and effective at the time of writing.
Legislative and regulatory dispositions are subjected to changes and updates by the
designated authority of the state or territory they refers to. The author declines any
responsibility or up-to-dateness, correctness, completeness of the provided information.
Last up-dated at 07/2015
NOTA SULLA RISERVATEZZA DEI DATI Le informazioni contenute in questo documento sono confidenziali, tutelate legalmente, e destinate unicamente al
destinatario designato. Qualunque utilizzazione, divulgazione, copia, distribuzione è vietata ed illegale ai sensi della legge 196/2003. Il ricevente, se diverso dal
destinatario, è pregato di distruggere il documento (e/o allegati) dandocene, cortesemente, immediata comunicazione a mezzo posta elettronica.
PRIVACY NOTE This message (and/or enclosures) contains confidential information belonging to the sender or intended recipient, destined solely for the use of
the individual or entity named above and copying, distribution or the taking of any use of its content is strictly prohibited as per Italian Law 196/2003. If you
receive this communication in error, please kindly notify us immediately and return us the documents.
Pagina
1
di
4
MD24 S.r.l.
Via Saragat 5 - 40026 – Imola – BO – (Italia)
 +39 0542 1892624
 +39 0542 641833
 www.md-24.net
 [email protected]
1
General information
Medical devices
According to the national regulation a medical device is defined as follow:
“Any instrument, apparatus, appliance, material, product; except products of human
origin or other article whether used alone or in combination, and including the software
necessary for its proper application intended, by the manufacturer, to be used for human
beings for medical purposes and that does not achieve its principal intended action by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means and whose main purpose is not obtained by pharmacological,
immunologic or metabolic reaction, but may be assisted in its function by such means”.
2
Class of risk
Medical devices can be divided in 4 risk classes: I, IIa, IIb, III based on the European
System of Class settled by the European Directive 93/42/CEE and subsequent
amendments.
3
The competent national regulatory authority
Medical devices are regulated by the Directorate of Pharmacy - Direction de la Pharmacy
et du Medicament (DPM) whose main role: “is control importation, manufacturing,
distribution and consumption of drugs and medical devices”. The technical control on
importation of medical devices was implemented in September 1994. A specific core
structure was created at the Department of Pharmacy and Medicine. This activity was then
distributed, over the years, in four departments of the Ministry of Health.
NOTA SULLA RISERVATEZZA DEI DATI Le informazioni contenute in questo documento sono confidenziali, tutelate legalmente, e destinate unicamente al
destinatario designato. Qualunque utilizzazione, divulgazione, copia, distribuzione è vietata ed illegale ai sensi della legge 196/2003. Il ricevente, se diverso dal
destinatario, è pregato di distruggere il documento (e/o allegati) dandocene, cortesemente, immediata comunicazione a mezzo posta elettronica.
PRIVACY NOTE This message (and/or enclosures) contains confidential information belonging to the sender or intended recipient, destined solely for the use of
the individual or entity named above and copying, distribution or the taking of any use of its content is strictly prohibited as per Italian Law 196/2003. If you
receive this communication in error, please kindly notify us immediately and return us the documents.
Pagina
2
di
4
MD24 S.r.l.
Via Saragat 5 - 40026 – Imola – BO – (Italia)
 +39 0542 1892624
 +39 0542 641833
 www.md-24.net
 [email protected]
4
Registration procedure
The regulatory reference for medical devices includes:
Resolution NO 41 of 7 March 1994 on foreign trade;
Ministerial Decree NO 1774 of 29 August 1994 on the arrangements for the
technical import and export and body accredited to exercise it;

The Ministry of Economy Letter of 30 August 1994 that establish lists of products
which are subjected to technical approval procedure for import and export;

The Minister of Trade and Crafts Letter of 15 September 2005 amending the Letter
of the Minister of Economy of 30 August 1994.


The Republic of Tunisia requires for all medical devices the Authorization for Market
Commercialization (AMC), issued by the DPM (Direction de la Pharmacie et du Medicament).
Heavy medical equipment, such as CT scanners or MRI, must obtain a separate license by the
Ministry of Health.
The foreign manufacturer, who wants to enter in the Tunisian medical devices market, must
appoint a Local Authorized Representative who plays the role of importer. The local agent
submits the required documentation to the Competent Authority in this way the foreign
manufacturer does not maintain the ownership of the obtained license, the local agent will
legally own the license obtained.
Thanks to agreements with the European Union, medical devices that have CE marking enjoy
a faster registration.
5
Information - documents - materials
Information on/ by the manufacturer – required documents
1
Request for authorization / provisional approvals by the importer or his Local
Authorized Representative, with full intention of not selling his products before he
had obtained the permission by the Competent Authority.
Information on the product – documents and materials required
1
Products list and batch number
NOTA SULLA RISERVATEZZA DEI DATI Le informazioni contenute in questo documento sono confidenziali, tutelate legalmente, e destinate unicamente al
destinatario designato. Qualunque utilizzazione, divulgazione, copia, distribuzione è vietata ed illegale ai sensi della legge 196/2003. Il ricevente, se diverso dal
destinatario, è pregato di distruggere il documento (e/o allegati) dandocene, cortesemente, immediata comunicazione a mezzo posta elettronica.
PRIVACY NOTE This message (and/or enclosures) contains confidential information belonging to the sender or intended recipient, destined solely for the use of
the individual or entity named above and copying, distribution or the taking of any use of its content is strictly prohibited as per Italian Law 196/2003. If you
receive this communication in error, please kindly notify us immediately and return us the documents.
Pagina
3
di
4
MD24 S.r.l.
Via Saragat 5 - 40026 – Imola – BO – (Italia)
 +39 0542 1892624
 +39 0542 641833
 www.md-24.net
 [email protected]
2
Products technical documentation
3
Certificate of Sterility, if applicable
4
Certificate of batch compliance
5
Certificate of origin, issued by the Chamber of Commerce
A one dinar revenue stamp must be attached to the above mentioned documentation.
The Competent Authority may demand additional documents, if deemed necessary for the
registration.
6
Labeling requirements
Label and instructions for use must be provided in French or Arabic.
7
Post-market requirements
Manufacturers, Local Authorized Representative are required to prepare a report on any
incident, adverse event, or recall from the market, related to the use of the medical device.
First of all the report must be transmitted to the DIP (Direction de l'Inspection
Pharmaceutique) for a sampling device, and then to the LNCM (Laboratoire National de
Contrôle des Médicaments) to perform a quality check, and at least to the DPM which, if
necessary, will perform an immediate product recall.
NOTA SULLA RISERVATEZZA DEI DATI Le informazioni contenute in questo documento sono confidenziali, tutelate legalmente, e destinate unicamente al
destinatario designato. Qualunque utilizzazione, divulgazione, copia, distribuzione è vietata ed illegale ai sensi della legge 196/2003. Il ricevente, se diverso dal
destinatario, è pregato di distruggere il documento (e/o allegati) dandocene, cortesemente, immediata comunicazione a mezzo posta elettronica.
PRIVACY NOTE This message (and/or enclosures) contains confidential information belonging to the sender or intended recipient, destined solely for the use of
the individual or entity named above and copying, distribution or the taking of any use of its content is strictly prohibited as per Italian Law 196/2003. If you
receive this communication in error, please kindly notify us immediately and return us the documents.
Pagina
4
di
4