Medical devices include any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
- intended by the manufacturer to be used, alone or in combination, for human beings; and
- which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, as defined by the International Medical Device Regulators Forum IMDRF(former Global Harmonization Task Force 'GHTF')
Medical Devices include an enormous variety of existing healthcare items, and many new forms are being constantly invented. It might be difficult for partner to identify whether a specific piece of equipment is a medical device or not. ECHO does not maintain an exhaustive list of medical devices classified as such.
Examples of medical devices can include: walking sticks, surgical instruments, contact lens lubricants, condoms, stethoscopes, insulin syringes and needles, wheelchairs, hearing aids, implantable devices, Magnetic Resonance Imaging (MRI), and Computed Tomography Imaging (CT).
However, for further information on the classification of medical devices you can look at these lists:
- Global Medical Device Nomenclature (GMDN) system designates 12 categories of medical devices consisting of more than 10,000 generic groups.
- The Universal Medical Devices Nomenclature System (UMDNS) is another nomenclature system being primarily used for medical devices.
- The WHO is also working towards a unified nomenclature system that can be used globally
Please note that mosquito nets are not classified as medical supplies
Irrespective of the value of the contract to be awarded, the Humanitarian Organisation shall procure medical supplies either:
- through an HPC, or
- by launching a procurement procedure
In the latter case, medical supplies must be purchased following a procurement procedure ensuring genuine competition (where possible), between pre-certified suppliers, which can offer pre-qualified supplies (i.e. both supplier and supplies must meet internationally recognized standards).
Therefore, when procuring itself, the partner should get the support of staff qualified in health care (e.g. pharmacist).
Before launching the procurement procedure, the partners will either have available or prepare a list of pre-certified suppliers that will be invited to submit an offer.
In order to be “pre-certified” a supplier will have had to demonstrate that it meets the following conditions:
- its premises and facilities meet internationally recognised standards;
- it is technically capable of ensuring the quality of active ingredients, and
- its products come from approved suppliers.
Please note that a self-certification made by a supplier is not sufficient proof that the supplier meets the international standards.
To assess the fulfilment of the status of pre-certified suppliers, the partner can rely on:
- its own assessment of the suppliers;
- proof of pre-certification by other donor (e.g. USAID)
- certification issued by an internationally recognised or reputable certification body (e.g. a WHO-approved body); or
- certification issued by a Stringent Regulatory Authority (i.e. a medical regulatory authorities in the EU, Japan or the USA)
The invitation to negotiate shall at least include the following award criteria
- compliance with essential requirements as described by the IMDRF (former GHTF) ;
- production in conformity with ISO standards and/or other equivalent standards as recognised by the IMDRF (former GHTF);
- recognition by at least one of the regulatory authorities or an equivalent entity: MPALS License (Australia), Device License (Canada), CE Mark (EU), Device License (Japan), and 510 k Device Letter (USA); and
- priority shall be given to candidates that have been accredited by a recognised accreditation entity, thus providing proof of compliance with at least one of the following standards or equivalent: Japan QS Standard for medical devices 1128, ISO 13485 on quality management system of an organization, and ISO9002/1994 on quality assurance in production, installation and servicing.
When comparing the offers received, the partners will compare prices taking into account the whole treatment per patient (transportation, storage, etc.) and not only the cost per unit. The partner will consult international medicines price databases, such as:
- International Drug Prices Indicator
- The Global Fund Price and quality reporting tool
- The price Information exchange website
- The global price reporting mechanism provided by the WHO AIDS medicines and diagnostics services
- MSF untangling the Web of antiretroviral Price reductions.
Proof of compliance with special provisions
The partners should keep in their files a thorough description of the various procedures described above: pre-certification and procurement procedure.
The partners should also be able to produce certificates of conformity, proof of quality and relevant documentation concerning the pre-qualification of drugs and the pre-certification of suppliers. All documents linked to quality assurance considerations, e.g. positive assessments by entities such as QUAMED and USAID should also be kept in the procurement file as evidence of quality compliance.
EXCEPTION ON QUALITY ASSURANCE DOCUMENTATION
The Annex III is mandatory in all cases as far as quality of food and medical supplies is concerned, regardless of ECHO contribution and regardless of the value of the procurement contract.
Thus, where the partner, for circumstances beyond its control, is unable to demonstrate compliance with internationally accepted product standards, it must follow these procedures
Destruction of Medical Supplies, Medical Devices and Veterinary Medicines
When procuring medical supplies, medical devices, or veterinary medicines, the Humanitarian Organisation shall ensure that adequate provisions are in place to ensure respect of internationally recognised best practices in the destruction of any contract-related supplies that are recalled or expired.