Technical Proposal for N95
A formal statement must be submitted by the supplier confirming that the N95 Respirator offered is in compliance with the following technical requirements:
- The product must be in alignment with the technical description and at least one of the norms or standards (indicating which one)
- The product must be in conformity with the regulatory requirements in the country of origin and at least one of the members of the International Medical Device Regulators Forum (IMDRF); and
- The product must be manufactured in compliance with ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, or an equivalent quality system.
- The supplier must present proof of compliance of the product with at least one of the correspondent technical standards. (certificates must be issued by the certification bodies or the test reports in accordance with the International Laboratory Accreditation Cooperation (ILAC) laboratory standards, or equivalent)
The product description must be provided by the supplier. It must include:
- brand or trade name,
- product descriptive information and intended use,
- a list of the materials,
- expected lifetime, and
- approved storage conditions.
List of all sites involved in the manufacturing process, including name, current address and manufacturing responsibilities/activities for each site as well as the list of outsourced processes with direct product impact, including details of the supplier for each process.
- Manufacturing site license issued according to the legislation of the country of origin.
- Proof of compliance of each manufacturer site involved in the manufacturing process with ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, an equivalent quality system standard; or a certificate of Good Manufacturing Practice (GMP), issued by the National Regulatory Authority of the country of manufacturer; or a Medical Device Single Audit Program (MDSAP) certificate.
The supplier must provide a copy of the product labeling. This includes the label, instructions for use, and information related to the identification, technical description, intended purpose and proper use of the product, and other instructional materials provided for users of the product, both professional and laypersons, as appropriate, and for relevant third parties*
Labels must minimally include:
- brand or trade name of the medical device,
- catalog number,
- contact information of the manufacturer,
- recommendations that would reduce sufficiently the risk of use,
- intended use
- handling measures for storage and transport,
- warnings and precautions, and
- particular product conditions (e.g. sterility).
- The instructions for use, where possible, should comply with the principles of labeling for medical devices and IVD medical devices of IMDRF/GRRP WG/N52 FINAL:2019.
* In any of the official languages of the PAHO Region: English, Spanish, French and/or Portuguese.
Right to share information with PAHO Member States
PAHO, at its sole discretion, may share with the corresponding National Regulatory Authorities from the recipient country, documents from the technical proposal or other documents and data requested for clarification or to resolve any potential claims or inquiries.