The new article provides additional details regarding the documents to be included in the submission dossier and also highlights some important aspects related to the procedures to be followed when applying for marketing approval. The general principles and requirements are addressed in the previous article.
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The Ethiopian Food and Drug Administration (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to marketing authorization for medical devices. The document describes in detail the applicable regulatory requirements and also provides recommendations to be followed by the parties involved to achieve and sustain compliance thereto. The scope of the guidance covers, inter alia, the aspects related to the application pathways to be followed when submitting an application dossier.
Declaration of Conformity
One of the most important documents to be included in the submission dossier is a declaration of conformity. By the device of this document, a medical device manufacturer assumes responsibility for ensuring compliance with the respective regulatory requirements of the product in question. As further explained by the EFDA, the declaration of conformity should contain the following:
- Confirmation of compliance of the products covered by the scope of declaration with the respective Essential Principles for Safety and Performance, as well as the corresponding requirements related to labeling and instructions for use;
- Details that are needed to identify a specific device;
- The Universal Medical Device Nomenclature (UMDN) code for the product;
- Indication of the particular class the device in question is assigned to by existing risk-based classification for the medical device as prescribed by the Principles of Medical Devices Classification;
- Date of issuance;
- Information about the medical device manufacturer, including its name and address;
- Information about the responsible persons signing the declaration on behalf of the manufacturer, including the name and position.
It is further stated that the said declaration will be subject to the authority’s review and examination together with ancillary documents submitted by the applicant. The present guidance also provides a template for a declaration of conformity to be used by medical device manufacturers applying for marketing authorization for their products in Ethiopia.
Marketing History
Apart from other details, the authority also expects the applicant to provide information about the global marketing history of the medical device in question. Such information should include the list of all jurisdictions where the product is allowed for marketing and use, accompanied by the respective authorization documents (e.g., marketing authorization / free sale certificates) issued by the national regulating authorities in these jurisdictions. The appropriate template is also provided by the EFDA.
Applications for Registration – Full Assessment
According to the guidance, certain regulatory procedures should take place before the new medical device will be allowed for marketing and use in the country. Furthermore, an efficient post-market control should be performed to ensure the continuous safety and effectiveness of medical devices that are available to customers.
A premarket assessment conducted by the authority starts from the initial evaluation of the application dossiers submitted by the parties interested in placing their products on the market. In this respect, the authority mentions that the regulatory frameworks to be applied in the case of general and in vitro diagnostic (IVD) medical devices are different. The key points to be considered by the applicants when preparing the submissions are addressed in the respective guidance documents issued by the authority. The authority additionally emphasizes that the entity applying for marketing authorization should be solely responsible for ensuring compliance with any regulatory requirements the product in question could be subject to, and for providing solid evidence demonstrating this. It is also important to mention that some of the medical devices are covered by the scope of respective exclusions, hence, should not be registered. Low-risk medical devices are exempted from the registration as well.
Registration of Products Approved by Other Authority
The present guidance also describes the situations when the medical device in question has been already approved for marketing and use by the competent national regulating authority recognized by the EFDA as a Stringent Regulatory Authority (SRA) and prequalified by the international agency, such as the World Health Organization (WHO). As further explained by the EFDA, SRA stands for a stringent government body or other entity that exercises a full legal right to control the use or sale of medical devices within its jurisdiction and may take enforcement action to ensure that medical devices marketed within its jurisdiction fully comply with legal requirements.
To benefit from this exemption, an interested party should provide supporting documentation confirming the marketing authorization granted by an SRA, together with the technical documentation containing all necessary information about the product subject to review. The same approach could be followed if the device in question is already pre qualified by an internationally recognized organization, which should be duly confirmed by the respective confirmation letter mentioning the product, or evaluation reports related to the device.
When following the pathway described hereinabove, an interested party may submit the following documents:
- A Marketing Authorization certificate or registration certificate or free sale certificate is issued by one of the following competent national regulatory authorities:
- US Food and Drug Administration;
- Ministry of Health, Labor and Welfare, Japan;
- Therapeutic Goods Administration, Australia;
- Health Science Authority, Singapore;
- Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2016;
- Medicine and Healthcare Products Regulatory Agency, UK;
- Health Canada, Canada;
- Ministry of Food and Drug Safety, South Korea;
- Evidence for WHO prequalification;
- Evidence for UNFPA prequalification.
The EFDA also reserves the right to amend the list of recognized jurisdictions and authorities.
The main purpose of the aforementioned regulatory pathway is to reduce the unneeded regulatory burden and accelerate the process of placing new products on the market while ensuring they meet the applicable safety and performance requirements. The authority additionally emphasizes that in case the applicant will intentionally submit incorrect information regarding marketing approval of a medical device subject to review, the application will be rejected.
Under the general rule, the applicants shall submit a complete dossier in all the cases, while the actual review process may vary depending on the particular framework applied.
In summary, the present guidance provides additional details regarding the documents to be included in the submission dossier and also highlights other important aspects associated with the submission. The document also explains the way the applicant may refer to marketing approval granted in another jurisdiction when applying for product registration in Ethiopia.
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