Medical Device Registration
Algeriais the largest country in Africa and is estimated to have a population of around 40 million people. Algeria has apublic health care system, which is accessible and free of charge to all citizens of Algeria. Meanwhile, Algeria\’s pharmaceutical exports will continue to expand, as the country gradually strengthens its position as a key drug manufacturing hub in the Middle East and Africa region. Import restrictions and market access barriers are set to benefit drugmakers that engage in domestic production or joint ventures with local manufacturers, although the Algerian market will remain dependent on imported high-end pharmaceuticals are given limited local production capacity for these products.
The medical devices are regulated by the Directorate of Pharmacy – Direction de la Pharmacy et du Medicament (DPM) under the Ministry of Health and Population (MOHP). Registration of Medical Devices for sale in Algeria requires approval from the Ministry of Health and Population (MOHP). Additionally, all documentation submitted to Algeria regulators must be translated into either French or Arabic language. Regulation of Medical Devices in Algeria is conducted by the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products (LNCPP), which are both under the supervision of the Ministry of Health and Population. Registration documents must be submitted to both bodies.
188金宝慱亚洲体育
Operon Strategist is a medical device consulting company which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
Contact UsWhatsApp
CLASSIFICATION OF MEDICAL DEVICE
– PREMARKET APPROVAL PROCESS
The premarket approval (PMA) is the second most commonly used pathway to market formedical devicesin the United States. It’s a process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. In fact, nearly 10% of medical devices are brought to market using this important pathway. However, since the PMA is reserved for the highest “risk” (i.e., class III) devices, devices like pacemakers, CT scanners and X-ray machines.
LIST OF REQUIRED DOCUMENTS
The registration procedure requires the following documents:
Information on the manufacturerdocuments required as follows:
- Application form
- Information on the manufacturer and the distributor
- Declaration of conformity
- CE certificate or equivalent
Information on the productdocuments required as follows:
- Instruction for use
- Label
- Product description
- Details on the biological product
- Risk class
- Storage conditions
- Device life cycle
- Device composition
- Device images
- Mechanism of action
- Indications, contraindications, warnings
- Method of sterilization
- The material used in the packaging
- Description of the inspections made on raw materials
- Report on the manufacturing process
- Report on the test mode on the device
- Clinical data
– POSTMARKET APPROVAL PROCESS
Postapproval requirements may include as a condition of approval of the device:
The manufacturer of 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 eu Medicament for possible removal of the medical device from the market.
