How to Register a Medical Device in Nigeria.
If you are a manufacturer or exporter of medical devices and you want to reach the Nigerian market, you need to register your products with the National Agency for Food and Drug Administration and Control (NAFDAC). This is important to ensure that your medical devices are safe, effective and of good quality for use in Nigeria. In this article, we will provide you with a step-by-step guide on how to register your medical device in Nigeria.
Step 1: Classification of Device
The first step to registering your medical device in Nigeria is to determine the classification of your device. Medical devices in Nigeria are classified into four categories- Class I, II, III and IV. The classification depends on the level of risk associated with the device. Class I devices are low-risk devices while Class IV devices are high-risk devices. To determine the classification of your device, you need to refer to the guidelines for classification of medical devices by NAFDAC.
Step 2: Submission of Application
Once you have determined the classification of your device, the next step is to submit your application to NAFDAC. You will need to provide detailed information about the device, including its intended use, mode of operation, technical specifications, labeling, packaging, and other relevant information. You must also submit a certificate of analysis and a certificate of free sale, as well as evidence of compliance with international standards.
Step 3: Evaluation of Application
NAFDAC will evaluate your application to determine the safety, efficacy, and quality of your medical device. This may involve laboratory testing of your device to verify its safety and performance. NAFDAC may also conduct an inspection of your manufacturing facility to ensure that your production processes meet international standards. An import permit will be issued for the samples of the products to be brought in for laboratory testing.
Step 4: Approval Stage
If NAFDAC is satisfied that your medical device meets all the requirements for safety, efficacy and quality, they will issue you with a certificate of registration. This certificate confirms that your device has been registered, and it allows you to sell your device in Nigeria.
Step 5: Post-Market Surveillance
After your medical device has been registered, NAFDAC will conduct post-market surveillance to ensure that your device continues to meet the required safety, efficacy and quality standards. This may involve periodic inspections of your manufacturing facility and your distribution channels, as well as monitoring of adverse reactions and complaints related to your device.
The following are the Documents Required to Register a Medical Device in Nigeria:
- Free Sales Certificate (FSC) and Manufacturing Certificate;
- Trademark Acceptance Form or Trademark Registration Certificate;
- Certificate of Analysis;
- Declaration of Conformity;
- Letter of invitation for GMP Inspection;
- Product labels and artworks;
- Notarized declaration from the Importer of Record/local agent;
- Power of Attorney from the manufacturer;
- Product Dossiers.
Regulatory Authority: National Agency for Food and Drug Administration and Control (NAFDAC)
Validity of License: Five (5) years
Renewal of License: Yes, possible.
Language: English
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Local Agent and Authorized Representative Services in Nigeria
Foreign manufacturers of medical devices require a local agent and an Importer of Record in Nigeria to register and export their products in Nigeria.
Registering a medical device in Nigeria can be a complex and time-consuming process. However, it is an important step to ensure that your device is safe and effective for use in Nigeria. By following the steps outlined herein, you can increase your chances of successfully registering your medical device with NAFDAC and entering the Nigerian market.
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For medical device registration services in Nigeria, contact us today!
We provide end-to-end regulatory advisory services, NAFDAC agent, and Market Authorization Holder Services in Nigeria. Call at +2348187019206. Email at admin@aspiresolicitors.com.