051111 MSU Tech Prov
General Technical Provisions - Medical Devices
1. GENERAL REQUIREMENTS
1.1 Medical devices purchased by UNICEF from manufacturers or traders must be produced and controlled in accordance with product standards and quality system standards recommended by the World Health Organization (WHO) and the Global Harmonization Task Force (GHTF). For more information see The GHTF founding members are Australia, Canada, the European Union (EU), Japan and the United States of America (USA). Goods that do not meet these standards are not acceptable to UNICEF.
2. MANUFACTURERS’ CONFORMITY WITH QUALITY MANAGEMENT SYSTEM STANDARDS
2.1 Manufacturers shall meet essential requirements in conformity with at least one of the following quality management system standards:
a) ISO13485: 2003
b) ISO9001: 2008
2.2 Suppliers shall provide copies of valid certificates of conformity.
2.3 The certificate(s) of conformity shall indicate:
a) Manufacturer’s certified quality management system standard(s)
b) Assessment body (name, country)
c) Last audit date and
d) Expiration date
3. PRODUCTS’ CONFORMITY WITH STANDARDS
3.1 Products shall meet the essential requirements as described in the GHTF document SG1-N41:2005: Essential Principles of Safety and Performance of Medical Devices.
3.2 The product shall be produced in conformity with ISO (International Organisation for Standardisation) standards and / or other equivalent standards as recognised by the GHTF.
3.3 The labelling of the product shall meet the essential requirements as described in the
GHTF document SG1-N43:2005: Labelling for Medical Devices.
3.4 UNICEF may request suppliers to provide copies of valid certificates of conformity.
3.5 The certificate(s) of conformity shall indicate:
a) Product conformity with standards (i.e. ISO or others)
b) Test Laboratory (name, country) and
c) Laboratory accreditation body (name, country)
Reference:
- Global Harmonization Task Force (GHTF) documents. Available at:
4. PRODUCTS’ COMPLIANCE WITH REGULATORY REQUIREMENTS FOR MARKETING CLEARANCE
4.1 Products shall comply with regulatory requirements for marketing clearance (as applicable), and be cleared by at least one of the regulatory authorities listed below. If the product has been cleared by more than one regulatory authority, suppliers should inform UNICEF accordingly.
4.2 Suppliers are requested to provide:
a) Name of regulatory authority of (at least one of) the following: Australia, Canada, EU, Japan, USA.
b) Marketing clearance with indication of license number, i.e.: GMPALS License or CE Mark (Australia), Device license (Canada), CE mark (EU), Device license (Japan), 510k device letter (USA).
c) Name of device (as submitted to the authority).
5. PRODUCT DOCUMENTATION
5.1 Suppliers shall indicate web site with electronic catalogue of their products (or if a web catalogue is not available, provide the most recent hard copy or CD-ROM catalogue unless already submitted to UNICEF within the last 12 months).
5.2 Suppliers must provide the following documentation for each product offered:
FINISHED PRODUCT
Manufacturer’s name
Subcontractor’s name (if applicable)
Manufacturing site (country of manufacture)
Manufacturer’s quality system standards
Product reference
Product short description
Product conformity with standards
Product marketing licence number (if applicable)
Product name as submitted to regulatory authority (if applicable)
Name of regulatory authority (if applicable)
Product shelf life in months (if applicable)
Product hazardous classification (if applicable)
Recommended storage conditions (if applicable) and
Complete technical specification, including technical data sheet with photo and / or design
Special Notes for Medical Devices
Consumable/renewable – sterile/non-sterile
1. SPECIFIC REQUIREMENTS
1.1 The devices shall:
a) Conform to style, design, functionality and dimensions as specified by UNICEF.
b) Conform to international standards for product packaging and labelling.
c) Be delivered with the manufacturer’s guidelines/instructions for use. Manufacturer documentation shall be available at least in English, French and Spanish.
2. SHELF LIFE
2.1 The supplier must provide the product’s shelf life in months (as applicable).
a) Products with a shelf life of less than 60 months are not acceptable (except for products with identified short shelf life).
b) Unless specifically authorised in writing by UNICEF prior to delivery to UNICEF, the supplier shall ensure that two thirdsof the shelf life remain at delivery. Any product delivered with less than two thirdsremaining shelf life, shall be rejected by UNICEF, at no cost to UNICEF. The supplier shall be responsible for and bear the costs for returning the goods.
3. CERTIFICATE OF STERILISATION
3.1 The supplier shall be required to provide manufacturer’s certificates of sterilisation related to each batch delivered to UNICEF.
3.2 The certificate of sterilisation shall indicate:
UNICEF purchase order number and item number
Manufacturer’s product reference and product short description
Manufacturing site/sterilisation site
Batch number (lot number)
Batch quantity
Date of sterilisation
Expiry date (month, year)
Sterilisation method
Process (standard) followed for validation and routine control for sterilisation of medical devices
Process (standard) followed for medical devices to be labelled “sterile” and
Name of the person responsible, title, date and signature
4. HAZARDOUS GOODS
4.1The supplier must provide the products’ hazardous classification.
Special Notes for Medical Devices
Equipment
1. SPECIFIC REQUIREMENTS
1.1 The devices shall:
a) Conform to style, design, functionality and dimensions as specified by UNICEF.
b) Conform to international standards for product packaging and labelling.
c) Have an identification plate stating: manufacturer’s name, country of manufacture, model type, manufacturing date, serial number and main characteristics.
d) Be delivered with the necessary manufacturer’s guidelines / instructions / diagrams for assembly, safe operation, maintenance and recommended spare parts (if applicable). Manufacturer documentation shall be available at least in English, French and Spanish.
e) Be compatible with the final destination of the goods, where this is known and specified by UNICEF,with regards to environment, climate, power supply, medical gas supply, water supply, drainage, etc.
2. SERVICES
2.1 Installation
The suppliermay be requested to provide installation services.The servicesshall include at least:
a) Installation at the end-user’s site.
b) Provision to end-user, well in advance of installation, of documentation describing pre-installation requirements.
2.2 Training
Thesupplier may be requested to provide training and related materials in the appropriate language for the final destination of the goods. Usually, the target audience for the training will be: medical and/or paramedical staff, and biomedical engineering and/or technical staff. The service shall include:
a) Workshops (hands-on sessions) on site - persons with expertise in the field of work to conduct:
User training: related to use of the equipment, its functionality and general safety procedures;
Technical training: related to technical principles of the equipment and its environment of use, assessment method for equipment functionality, preventive maintenance and first line technical intervention.
b) The provision of necessary training materials such as: operational manuals, technical manuals, diagrams, calibration materials, reagents, consumables, etc.
2.3 After-sales service
The supplier may be required to provide:
a) A list of authorised local/regional agents and/or distributors related to the final destination of the goods - who offer after-sales services, including technical services and spare parts.
b) A reference list of locations in the country and/or abroad where similar equipment is being operated.
110119 MSU AMF - 1