PPE Regulatory approvals and certifications during COVID-19 by the World Health Organization
Updated: Mar 8, 2022
For all the PPE and related IPC supplies the following regulatory approvals and certifications apply.
It should be noted that in some economic regions, some PPE is considered a medical device and therefore the relevant regulations are to be followed. In other regions, some PPE may be considered an industrial protection garment and not tagged for medical use.
Due to limited manufacturing capacity some products might come from other economic regions or might have “emergency use authorizations” from regulatory agencies. Therefore, the requirements listed below might apply only to the COVID-19 period and may be updated; otherwise, they will be valid for up to 2 years following publication.
Primary packaging
Labelling on the primary packaging needs to include: Name and/or trademark of the manufacturer.
Model or product reference.
Information for particular storage conditions (temperature, pressure, light, humidity).
Quality management system from the manufacturer, for the PPE types
Certified quality management system for medical devices (e.g. ISO 13485) and application of risk management to medical devices (e.g. ISO 14971), if applicable.
General quality management (e.g. ISO 9001) (for non-medical devices). European Union (EU) Module C2 or D conformity to type certificate (Category III CE certified PPE only).
Regulatory approval/ certification
Free sales certificate (FSC) of medical device and related IPC products.
Certificate for exportation of medical device and related IPC products, provided by the authority in manufacturing country (in case of imported goods).
National local regulatory approval (of recipient country, as applicable). Proof of regulatory compliance, as appropriate, per the product’s risk classification (e.g. Europe: Conformité Européenne [CE] certification and declaration of conformity and/or EU type examination certificate as applicable, e.g. PPE cat. III for respirators; USA: Food and Drug Administration [FDA] approval or emergency use authorization; China: National Medical Products Administration [NMPA] listed). Ability for purchaser to check authenticity directly with the issuing regulatory authority (e.g. online database of active licences).
Category I PPE, may accept self-declaration with declaration of conformity (COVID-19 context).
Authorized representative must be identified and document expiration date supplied (valid until).
Test reports
Official test reports (all pages, in English) must either originate from accredited test labs, whereby the accreditation authority is preferably a member of International Laboratory Accreditation Cooperation (ILAC), or from an EU notified body. Accredited facilities should be ISO 17025 certified.
Test reports should clearly indicate the accredited laboratory name and accreditation (for regulator or procurer, to be able to check authenticity of test reports). Test standard must be within the scope of the accreditation of the laboratory.
CE certificates (EU type examination certificates) for category III PPE should mention the notified body name/ number. Instructions for authentication of test report(s) and certificates should be provided.
Ability for purchaser to check authenticity directly with the accredited test laboratory (e.g. online uploading of test report and automatic version check, or emailing test facility).
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Source: World Health Organization