HYPROOF CYCLE USE FACE
Reusable, Washable, Comfortable, & Very Breathable with Adjustable Earloops
- 5 layers (2 Cotton/1 hyproof film/2 polypropylene nonwoven fabric)
- BFE : 99.2%, PFE : 97%, ASTM F2100-19
- Adult : 6.89” length, 3.35” width
- Child: 7.48” length, 4.72” width
- 1 mask per pack (100 masks per carton)
- Available in 4 different colors and patterns.
To import radiation-emitting products you should first understand what these products are and their requirements (FDA)
Not everyone is aware of the regulations around that topic.
The FDA is very clear: if your product is a radiation-emitting electronic product as any electrically-powered product you will have to disclose this when the shipment enters the USA.
Here some examples that constitute a radiation-emitting product :
- mammography devices,
- magnetic resonance imaging (MRI) devices,
- liquid crystal displays (LCDs),
- light-emitting diodes (LEDs)
Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005.
Radiation-emitting electronic products subject to U.S. Federal Performance Standard require submission of Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, at the time of entry.
Products not subject to federal performance standards do not require a Form FDA-2877 for importation into the US. At the time of importation, FDA will verify the declarations submitted on Form FDA-2877
Your Initial Importer is not your Importer of Record
Why so much confusion?
We often get that question, ”As our initial importer, could you also be our importer of record? ”
The short answer is no unless we have a financial interest in the transaction.
The FDA requires foreign manufacturers to make sure the importer is registered with them. Dawa Medical LLC has been registered with the FDA for 5 years.
However, an importer of record (IOR) is the entity or individual who is responsible for all entry documents required by Customs Border Protection. The IOR is also responsible for the product classification and payment of duties.
What are the risks when acting as the importer of record?
I. Audit risk – depending on the local laws and regulations, the IOR is open to be audited for any transactions, up to 7 years after the import is complete.
II. Financial risk – the audit can result in subsequent revaluations of the import. That could mean larger tax bills and penalties relating to the import.
III. Legal risk – non-compliance with import regulations could result in the loss of import licenses.
IV. Operational risk – improper importing procedures may result in the shipment being temporarily held or permanently seized by customs.
Medical Device; a fast growing market !
There are so many great minds in the medical device industry & those minds are changing the healthcare system through innovation and entrepreneurship to serve patients better.
Follow the link below for a very interesting interview with Dr Rivelino Montenegro from Monarch BioImplants manufacturer of Neuroshield.
Dawa Medical is pleased to represent Monarch BioImplants in the USA as a master distributor and as an Initial Importer.
Do you need an Initial Importer ?
Are you a foreign manufacturer of medical devices ?
If the answer is yes, you need to pay attention at the FDA regulations about exportation to the US market.
If you don’t have a physical presence in the US and if that establishment in the US is not registered with the FDA, you need to make sure your buyer in the US is registered as Initial Importer to the FDA.
The best option is to work with a third party who could be your Initial Importer umbrella for the entire US market.
But don’t worry, we can help !
V-Strut has been officially launched in USA !
We are pleased to announce we have done the first ”Operative Technique Training” with Dr Harry Brown, Diagnostic Neuroradiologist & Interventional Pain Management at the Radiology Partners in Chicago.
In a meta-analysis of more than 2 million patients, those with osteoporotic vertebral compression fractures who underwent vertebral augmentation were 22% less likely to die at up to 10 years after treatment than those who received nonsurgical treatment, RSNA 2020
AdvaMed Joins AORN, AHA in Issuing “Re-entry Guidance for Health Care Facilities and Medical Device Representatives
In response to the COVID-19 pandemic, hospitals and surgical facilities nationwide paused elective surgical procedures and other nonemergent and nonessential services, limiting physical access to facilities for nonessential health care personnel, patient visitors, and medical device representatives.