Service Schemes for Medical Device Export to
the European Market
If you are a manufacturer of protective masks, and you want to enter the U.S. market, we provide you with the following service scheme:
Application for U.S. NIOSH certification of protective masks
Protective masks are managed by the National Institute of Occupational Safety and Health (NIOSH) of the U.S. NIOSH divides the masks into 9 categories: N95, N99, N100, R95, R99, R100, P95, P99, and P100. In a sense, N95 is considered a category with a relatively low level of protection.
Timing of application for U.S. NIOSH certification of protective masks
For manufacturers of protective masks, once they plan to export their products to the U.S., they must prepare samples in advance for inspection and apply for NIOSH certification.
Masks for NIOSH certification must meet the requirements of 42 CFR Part 84. The testing indicators include expiratory resistance, expiratory valve leakage, inhalation resistance, and filtration efficiency.
Process and cycle of application for U.S. NIOSH certification of protective masks
1) The commissioned party assists the client to prepare samples, contacts the laboratory, and makes corrections according to the product testing results that need to be rectified;
2) The commissioned party compiles the application materials, provides the NIOSH application form, and assists the client to complete the revision of relevant materials;
3) The commissioned party assists the client to rectify the nonconforming items found in the audit;
4) Accept the NIOSH review (not required to review the site), and get the NIOSH N95 approval.
Cycle: from preparing the samples to getting the N95 approval, it takes about 4-6 months.
