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(2014; 100 pages)
EFMHACA would like to acknowledge the United States Agency for International Development (USAID) and the U. S. Pharmacopeial Convention Promoting the Quality of Medicines Program (USP PQM) for the financial and technical support delivered in preparation of this Guidance.
This Guideline has been revised based on the Authority's day-to-day experience as well as recommendations on the regulation of medical devices by other international organizations. The method of classification for medical devices other than IVD medical devices stated in this Guideline depends on the intended use of the device, indications for use, duration of use, degree of invasiveness, and local vs. systemic effect of the device. The method of classification for IVD medical devices is based on individual vs. public health risk and on the intended use of the device either by lay persons and/or health professionals. The basic rationale for classification of the device is to proportionate the risk of the device and the technical requirement addition; the classification is risk-based, that is, the risk the device poses to the patient and/or user is a major factor is determining to which class it is assigned.
It is understood that because of the vast number and changing nature of variables involved, it is difficult to set a simple classification rule and examples for all cases. However, the general approach for device classification is as indicated in Annex II for Medical Devices other than IVD, and Annex III for IVD Medical Devices. The manufacturer generally assigns the class of the device; it is the responsibility of the Authority to accept the assigned allocation of the device based on its safety and performance characteristics. In cases where the manufacturer is unable to classify its device, consultation with the staff of the Authority is important.
The class to which the device is assigned determines, among other things, the type of pre- marketing submission/application required for registration, and the elements of safety and performance conformity assessments. Roman numerals I, II, III, and IV are used to classify medical devices other than IVDs, and the Alphabet (A, B, C, and D) is used to classify IVD medical devices for easy identification and alienation.
This Guideline consists of six sections, five annexes. All devices, including IVD medical devices, should meet the essential principles of safety and performance requirement described in Section I. Medical devices other than IVD medical devices should meet the device safety and performance conformity assessment requirements stated in Section II. The extent of the requirements depends on the risk and class of the device. Section III provides the requirements for the conformity assessment of an IVD medical device. Requirements for re-registration and variations of medical devices are provided in Section IV and Section V respectively. Section VI provides the requirement for registration of medical devices with SRA procedure.
Separate applications and dossiers are required for each device falling in Class III and above for medical devices other than IVDs, and for each device in Class C and above for IVD medical devices. Where applicable grouping of medical devices for lower class medical devices is acceptable, the Authority will handle them on a case-by-case basis.
Before making an application for registration, the manufacturer is required to classify his device and compile the data and information needed based on the requirement for that class of device. Thus, the applicant and the staff of the Authority should refer to the principles of device classification and the Guideline section on - Borderline Issues, as well as with other international guidelines such as GHTF guideline on medical devices.