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，这是可以访问的，并免费提供给阿尔及利亚的所有公民。同时，随着该国逐渐增强其作为中东和非洲地区关键药品制造中心的地位，阿尔及利亚的药品出口将继续扩大。进口限制和市场访问障碍将使从事国内生产或与当地制造商合资的制药商受益，尽管阿尔及利亚市场仍将依赖进口的高端药品，但这些产品的本地生产能力有限。
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.
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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.
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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 manufacturer所需的文件如下：
- 申请表
- 有关制造商和分销商的信息
- Declaration of conformity
- CE certificate or equivalent
Information on the product所需的文件如下：
- 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
- 包装中使用的材料
- 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.
