WARNING: Fake product certification is rising particularly with respect to Respiratory Protective Equipment (RPE).
The exploitation of law loopholes is mainly translated into not registering these products as medical devices, thus avoiding proper launch into the market via Notified Bodies and Competent Authorities involvement. Fake certificates and lack of declaration of Conformity jeopardises public health and imposes an additional risk for healthcare providers, who are currently fighting against the COVID-19 pandemic. We advice our clients and readers to always check whether the company issuing the certificate is a designated Notified Body via the NANDO website.
– ECM – Medical Devices (Ente Certificazione Macchine) issues a warning to protect users in this critical juncture for public health. Read more: ECM warning announcement
– BSI issues a warning: Read more: BSI warning letter
– The Chinese Government rings the bell: Read more Chinese Government warning
– Financial Times highlights 2 reasons triggering this malpractice:
- […] Almost a fifth of China’s mask factories only began operating after January, according to official data, ranging from apparel factories to electronic makers […]
- […]Chinese makers of face masks are taking advantage of loopholes in #EU and #US regulatory processes to speed up the manufacture and sale of the equipment, as they race to meet an explosion in overseas demand to combat the global spread of coronavirus […]
Read more: FT article
