Medical Devices are used in the healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The Egyptian Ministry of Health (MOH) is responsible for the registration and approvals of medical devices in Egypt through the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA) which also regulates the importation and manufacture of medical devices.
In order to import the medical devices in Egypt, the applicant should submit and be registered at the Importer Record.
The Required documents to obtain a registration license
- Request for registration in the register of importers on behalf of the General Manager of the Licensing Department and Commissioning;
- A detailed statement of the activity details indicating each agency and the imported items, the aforementioned applications shall be submitted on the letterhead of the company signed by the applicant, dated and stamped by the company's stamp;
- The agencies contracts must be legalized from the Egyptian embassy in the country of origin;
- A copy from the S14 "Importing Agents Card" ;
- The original experience certificate from the Commercial Chamber, directed to the Central Administration of Pharmaceutical Affairs (CAPA);
- The criminal record of the applicant, directed to CAPA;
- A copy of the commercial registration;
- A copy of the Tax-Card;
- A maintenance center license, extracted from the Industrial Control Authority.
Egypt has adopted the European Risk Classification System for medical devices (Class I, IIa, IIb, and III). Therefore, Applicants should classify their devices accordingly, as Class I (low risk), Class IIa or Class IIb (medium risk), or Class III (high risk). Class I, Class IIa and Class IIb devices are registered at the DPPC where an import approval or manufacturing approval is issued at the end of the procedure. Whereas Class III devices are registered at CAPA where a registration number and a marketing authorization are issued. The applicant cannot manufacture or import these products unless the registration number and marketing authorization are issued. The class and type of device will determine which procedure will apply as follows:
Registration of Class I, Class IIa and Class IIb devices at DPPC
Importer or manufacturer should submit a request for approval in a file, on the company’s letterhead with the company’s stamp, to the DPPC attached with it the following documents:
- The license of registry in the list of importers of devices and medical equipment at CAPA;
- Invoices (or pro-forma invoices) for the equipment from the country of origin;
- Bill of Lading;
- Detailed original catalog(s) of the product(s);
- For importing companies: proof (e.g. Contract) that the company is an approved agent or the sole distributor for the foreign parent company in Egypt;
- For importing companies: the S14 form (a form issued by the Ministry of Industry) that records the relationship between the Egyptian company and the foreign company (approved agent or sole distributor);
- If the importer is a company other than the sole distributor for Egypt (e.g. an additional distributor), an approval letter from the certified Egyptian sole distributor is required;
- In case of the importer is importing medical equipment or devices from a country other than the country of origin, an original letter is required from the parent company (certified by the Egyptian Embassy or Consulate) stating its approval for the importer to be a distributor in Egypt or the Middle East region;
- Submit certified high-quality service center (for repairs), if applicable;
- In the case of radiology or X-ray equipment, approval from the Office of Radiation Safety is required;
- In case of Class I non-sterile devices, the only requirement is a declaration of conformity is required. For all other medical devices, one of the following documents is required:
- Original Free Sale Certificate stipulating that the product is freely sold in one of the reference countries which are Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, the UK and the USA;
- Original Conformité Européenne (CE )Certificate; or
- Original FDA Certificate (certificate from the Food and Drug Administration).
N.B: CE certificate (certified by the Egyptian Embassy or Consulate) must be submitted.
Application files submitted by doctors to use devices in a private clinic must include a copy of the clinic license. Application files submitted by hospitals must include a copy of the hospital license. Application files submitted by medical device manufacturers must include a copy of the factory license (issued by CAPA).
However, not all applications submitted before the committee must obtain the approval of the committee. The committee has the right to refuse any application submitted before it with reasoned decision and the applicant can appeal the community decision. In addition to that, the committee can consult others to give its approval.
Registration of Class III devices at CAPA
An importer or manufacturer should submit a registration file to the Head of Department of Registration at CAPA
- A formal request to register the product on the company’s letterhead stating the name of the product, name and contact information of the foreign company and the country of origin. The letter should be signed and stamped by the importer company;
- A formal letter on the company’s letterhead with a pledge from the company that it will import this product only from the country of origin. The letter should be signed and stamped by the importer company;
- The license of registry in the list of importers of devices and medical equipment at CAPA;
- A photocopy of the proof (e.g. contract) that the company is an approved agent or the sole distributor for the foreign parent company in Egypt (the original might be requested for comparison with the photocopy);
- The S14 form (see above);
- If the importer is a company other than the sole distributor for Egypt (e.g. an additional distributor), an approval letter from the certified Egyptian sole distributor;
- An original free sale certificate stating that the product is freely sold in the country of origin; certified by a health authority in the country of origin and the Egyptian Embassy or Consulate. This letter must be original and certified by the corresponding authority;
- An original, valid CE certificate certified by the Egyptian Embassy or Consulate;
- The original technical file, signed and stamped by the foreign company, containing:
- A certificate detailing the full composition of the;
- The test method of the finished product;
- The certificate of analysis of the finished product conforming with finished product specifications, issued by the quality control department at the manufacturing foreign company;
- For sterile products, the certificate or the method of sterilization;
- Sketch diagram and dimensions;
- The certificate for the stability data (validity time);
- The certificate explaining the material of packaging (external and internal if applicable) and the number of units in each package;
- Internal and external label(s) of the product;
- One sample of the product labeled with the name of the manufacturing company, the country of origin, number of CE certificate (identical with the submitted CE), manufacturing and expiration dates.
After obtaining the approvals, the registration of the Medical Devices will be valid for 10 years from its registration date.
Required Documents for the release of the imported Medical Devices
1-Formal Request Signed& stamped from the importing company to obtain approval for importation of medical device;
2- Copies of Performa Invoice described the review country;
3-Importer Record License of Egyptian company added to the foreign company;
4-Commercial Register and the Tax Card;
5- "Distribution Agency Agreement" between importing Egyptian and exporting foreign company;
7-Catalog showing the logo for the factory, use the product and models and matching it;
8- Certificates of quality coming from the same country of origin of the accessory and matching them, namely:
Declaration of conformity includes the following:
- Entails a quality or medical device manufacturer is responsible for foreign +Declare Purpose and Use.
- Classification of the medical device (class l, class lla, class llb, class lll).
- MALE quality CE certificate number on the product and follows the Medical Device Directive.
- Certificate of CE (Medical directive 93/42/EC) and the Annex containing the appropriate classification;
- Certificate of free sale from the country of origin valid date;
- Certificate of Food and Drug Administration (FDA).
9- Approval marketing of the product sterile issued by the Central Administration of Pharmaceutical Affairs;
10- Approval of the Executive Bureau of the rays in the case of X-ray equipment;
11- Approval of the National Institute for the laser science in case of importing lasers;
12- In case of import of spare parts for the medical device is presented certificates to the abovementioned device and a piece suggesting that the parts belong to the device provided with quality certificates;
13- Result of the analysis sample from the Faculty of Engineering Supplies bone from countries other than the reference;
14-Prior approval (if any) Pledged that it will be contained in the data fully describes the manufacturer and supplier of foreign company (if applicable) and country of origin written on it (Made in..........).
As concluded from the aforementioned, there are so many requirements, approvals and procedures for the registrations process. However, the Egyptian Regulators have the right for requiring such strict procedures in which it will assure safety and high efficiency of the devices for the human use and patient's health, also it will reduce the probability of submitting forged certificates to the registration department of the Ministry of Health. Given the complexity of procedures and list of documents, it is always reasonable to seek legal advice in order to ensure strict compliance to the Egyptian regulations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.