4 - MD24 Srl

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
ALGERIAN MINISTRY OF HEALTH
disclaimer
(www.sante.gov.dz)
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.
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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
According to the article 173 of the Ministerial Decree 08-13, of 20 July 2008, a medical
device is:
“Any apparatus, clothing, instrument, appliance, material or product, except products of
human origin, and article, whether used alone or in combination, including the software
(necessary for its proper application) intended, by the person under whose name it is or is
to be supplied, to be used for human beings for the purpose of one or more of the
following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation
for an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception”.
2 Class of risk
This Classification System is similar to the European one and it is based on 4 classes of
risk: I, IIa, IIb, III.
3 The competent national regulatory authority
Medical devices are regulated by the Directorate of Pharmacy - Direction de la Pharmacy
et du Medicament (DPM) - under the supervision of the Ministry of Health and Population.
DPM main role is to control importation and the devices commercialization in the Algerian
market.
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.
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di
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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 85-05 of 16 February 1985 on health protection and promotion;
 Ministerial decree No. 08-13 of 20 July 2008, which amends and integrates the
above-mentioned resolution;
 Ministerial decree of November 30, 2008, which prohibits the import of
pharmaceuticals and medical devices whose demand is covered by local production;
 Ministerial decree No. 387 of 31 July 2006 that indicates the mandatory requirements
to perform clinical trials on medical devices in Algeria.
The foreign manufacturer, who intends to place medical devices on the Algerian market, must
first nominate a Local Authorized Representative; indeed it is necessary, for all medical
devices including custom-made medical devices, to present a series of documents to the
Department of Pharmacy and Medicines using a this Representative local company.
The documentation, listed on the below paragraph, must be submitted to the Competent
Authority of Algeria and it must be written in French or Arabic.
5 Information - documents - materials
Information on the manufacturer – required documents
1
Application form
2
Information on the manufacturer and the distributor / Local Authorized
Representative (name, business name, address)
3
Declaration of conformity
4
CE Certificate or equivalent
Information on the product – documents and materials required
1
Instruction for use
2
Label
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.
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di
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MD24 S.r.l.
Via Saragat 5 - 40026 – Imola – BO – (Italia)
 +39 0542 1892624
 +39 0542 641833
 www.md-24.net
 [email protected]
6
3
Product description ( trade name, specifications, manufacturing site)
4
Details on the biological product, if applicable
5
Risk class
6
Storage conditions
7
Device life cycle
8
Device composition, if applicable
9
Device images or pictures
10
Mechanism of action, if applicable
11
Indications, contraindications, warnings
12
Method of sterilization, if applicable
13
Material used in the packaging
14
Description of the inspections made on raw materials
15
Report on the manufacturing process
16
Report on the test made on the device
17
Clinical data
Labeling requirements
Labels and instructions for use must be provided in French or Arabic.
7 Post-market requirements
The manufacturer or the Local Authorized Agent must prepare a report on any incidents,
adverse events or recalls from the market linked to the use of a medical device. The report
must be submitted to the DPM - Direction de la Pharmacy et du Medicament for a
possible removal of the medical device from the market.
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.
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