The new article describes in detail specific aspects related to the products placed on the market by virtual manufacturers and highlights the main points related to the responsibilities of all the parties involved in supplying medical devices in Ethiopia.
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the marketing authorization of medical devices. The scope of the guidance covers, inter alia, the aspects related to placing medical devices on the market by virtual manufacturers. According to the definition provided by the EFDA, a virtual manufacturer stands for a manufacturer that fully sources its own named product from another company (sometimes known as the “original equipment manufacturer”), which has designed and manufactured an identical EFDA approved product and taken legal responsibilities by placing its name and address on the product. The above concept is similar to the concept of “white label manufacturer” used in other jurisdictions.
The document provides non-binding recommendations and clarifications regarding the applicable regulatory requirements and is intended to assist the parties involved in assuring compliance thereto. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective changes to the underlying legislation.
Responsibilities of a Virtual Manufacturer
First of all, the document outlines the scope of responsibilities of a virtual manufacturer. According to the guidance, a virtual manufacturer shall duly develop and implement a quality management system to be audited by the respective conformity assessment body or the authority itself. Apart from this, such manufacturers are also obliged to keep all necessary technical documentation related to the products they are dealing with and provide such documentation to the authority upon request. As further explained by the EFDA, the virtual manufacturers:
- Have to fulfill their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;
- Should integrate the quality system of critical subcontractors and crucial suppliers with their quality system;
- Need to control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.
Apart from the above, the authority also mentions that the appropriate Declaration of Conformity should be signed by the visual manufacturer to reaffirm compliance with the applicable regulatory requirements for the product in question. The authority explicitly states that any medical device manufacturer should strictly comply with the applicable regulatory requirements, irrespective of the class of the product in question under the existing risk-based classification.
As was mentioned before, virtual manufacturers should duly hold comprehensive and complete technical documentation related to the product they are going to market under their name. The scope of the said documentation should cover all the important aspects related to the manufacturing process, and also to the medical device itself. In particular, it should address the matters related to risk assessment or labeling. At the same time, the authority also mentions that a specific approach could be applied due to the nature of the relationship between the virtual manufacturer and the actual one. For instance, in certain cases, the scope of information to be provided to the authority could be limited, as long as the details included are sufficient for the EFDA to complete the assessment of the safety- and performance-related matters. In certain cases, the actual (OEM) manufacturer should disclose the information directly to the EFDA. According to the guidance, the proprietary information that could be redacted may include:
- Unique material formulae or ingredients which are specific to the medical device and not in general use which are of high commercial and intellectual benefit to the OEM;
- Unique manufacturing processes which have been designed by the OEM and give them a competitive advantage in the marketplace;
- Technical drawings and technologies (applicable where a patent is also being applied for) but not yet granted;
- Software algorithms.
At the same time, the EFDA explicitly states that the information related to the above mentioned aspects should not be fully removed, while all the redactions made to remove proprietary information should be duly justified. Moreover, in such cases, top-level information should be provided, allowing the authority to assess the risks associated with the product. The authority also mentions that a virtual manufacturer should be responsible for the accuracy and completeness of the information provided.
Agreement Between the OEM and the Virtual Manufacturer
The guidance also addresses the aspects related to the agreement to be concluded between the original equipment manufacturer, and the virtual one. In particular, the authority highlights the main points to be addressed in the said agreement. According to the guidance, the agreement should contain, inter alia, the following:
- Provisions regulating post-market surveillance activities and outlining the distribution of responsibilities associated thereto. In this respect, it is important to take measures to ensure that the original manufacturer is duly notified about any incidents and adverse events associated with the product. At the same time, should the OEM manufacturer be the first to become aware of the issues associated with the medical device, it should duly notify the virtual manufacturer.
- Post-market clinical follow-up provisions.
- Provisions describing the approach to be applied concerning changes to the medical device.
- Provisions regarding the unannounced audits the authority may undertake to ensure the proper quality of the products and validate compliance with the applicable regulatory requirements.
- Exclusivity provisions explicitly prohibit the OEM manufacturer from entering the same agreement with another virtual manufacturer regarding the same product.
- Information disclosure provisions require the OEM manufacturer to provide comprehensive information about the product to the authority upon request.
- Provisions regarding mandatory certification to be completed by the OEM manufacturer.
Virtual Manufacturers and Distributors
The document also describes the criteria to be applied to differentiate virtual manufacturers and distributors. According to the guidance, an entity will be considered a distributor in the case it:
- Merely supplies the product accompanied by the translated version of the labeling, provided the content of the labeling remains intact;
- Makes changes to the outer packaging of the product already available in Ethiopia, without making changes to the product;
- Places its name together with the name of the original manufacturer;
- Provides clear information about the roles of the parties involved in the supply of medical devices;
- Abstains from making changes to the intended purpose, the device itself, or its packaging.
Furthermore, the authority also states that in the case of a manufacturer-distributor relationship, there should be no agreement between the parties as described hereinabove, and the information about the original manufacturer should be provided when making the device available on the market.
In summary, the present EFDA guidance provides additional clarifications regarding the existing regulatory framework for virtual manufacturers. The document highlights the most important aspects to be considered and describes in detail the agreement to be concluded between the parties involved.
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