Sourcing Masks From China: Certifications, Customs & Lead Times

By now, the need to wear a mask might seem like old news. However, as wearing a mask is part of our “new normal,” it might be easy to forget the importance of using a good quality and the right kind of mask, especially in high-risk environments.

The Market

Sourcing masks means addressing the demand of the market.  Is there a market? If so, how long will it last?

We discussed two types of masks in our last blog, Sourcing Masks from China: An update. The challenging N95 and the simpler surgical/reusable cloth masks.

Despite initial resistance in many markets, the compelling scientific evidence that masks help control Covid-19 resulted in increasingly broad adoption of the practice. In terms of volume, the re-usable cloth masks are winning because, among other reasons, they are cheaper, easier to get and most people don’t like wearing N95 masks. And there are much less certifications and restrictions for these types of masks.

So there is a huge market. How long will this trend last is less certain.  But it seems likely it will be for at least one year – some people say it could be a lot more than that. This trend is so strong that it is transforming masks into fashionable items.

With that said, many companies have questions about importing masks, both cloth and N95 because there have been updates and changes to certification and customs requirements.

Certifications Required

Before committing to a supplier, it’s important to be aware of the certifications required to export masks.

Cloth masks: Surgical and re-usable masks fall under the Industrial protection FDA Class 1: This class of medical devices pose minimal threats to the user and are usually simple in design and exempt from the regulatory process. Thus, they are considered to be exempt to the certification requirements.

N95 masks: Medical protection masks fall under FDA Class 2. Most medical devices are considered to be in this category and require general controls and pre-market notification. The FDA will assign a distinct product code, DWL, for these types of devices.

In Europe, the CE Mark (Conformité Européenne Mark) is required before the item can be sold to the general public and must have the following filtration standards:

• FFP2: minimum filtering effect ＞94% or
• FFP3: minimum filtering effect ＞98%

Customs:

Export of N95 masks now require a written or electronic declaration, signed by the exporter and importer, for customs purposes that state that the exported products:

– Have obtained the registration certificate of Chinese medical devices

– Meet the quality standard requirements of the importing country (region).

China is currently clearing exports for shipments from manufacturers on the MOFCOM list, or not on SAMR (State Administration for Market Regulation) list. MOFCOM responsible for updating this list, according to Sandler, Travis, Rosenberg, PA., an international trade, customs and export law firm.

For medical use N95 face masks, as of March 20, 2020, HS codes were updated, and the codes for masks and protective clothing was split and adjusted. Tariff exclusions were also granted on face masks during this time. On April 1, the Chinese Government increased requirements on the export of all corona-virus related supplies including medical masks, medical protective clothing, ventilators, and infrared thermometers.

As of April 26, exporters must submit certification that show details of the PPE quality standards.

For non-medical, re-usable cloth face masks, importers must simply confirm that quality standards are accepted and will not be used for medical purposes.

Lead Time

A major concern for importers of PPE is timeline and quick delivery. According to our own China team, lead times are as follows:

– Production time: 10-15 days

– Air Freight: 5-7 days

– Some importers are now using sea freight because they are using large volumes, want to keep costs down, and can anticipate market needs 3 months down the line.

The bottom line is that sourcing special (N95) masks is more challenging but it is more streamlined than before.  Sourcing cloth masks poses no additional difficulty.  The market for both remains very strong, with much higher volume for the latter.

Also, you should note that CPG does not sell masks. But we have been helping some of our clients source masks safely, responsibly – and efficiently.

Contact us to find out how we can help.

 

By Jocelyn Trigueros