Just because its OK here, doesn’t mean it’s going to be OK there.
Last year CVEN worked with a number of medical companies seeking to qualify not only their opportunities in the global market, but also their ability to meet compliance in the foreign country.
The following case study examines one of our client’s experiences and how we worked to clear the fog and secure them a pathway.
USA and the ever-growing challenge of compliance.
Whether you are selling medical products or food stuffs, sooner or later you are going to learn about the USA’s big brother. We call them the CBP or Customs Border Protection.
In many countries today, compliance with local rules and regulations are becoming more and more stringent. Consumers are demanding Governments play a more active role to ensure the safety and quality of products they allow into a country.
A quick scan of international media and you will find many examples of customs officials seizing intentionally mislabelled, fake and sometimes dangerous imports.
In this case, the CVEN team were engaged by an Australian based medical device manufacturer. The product was simple, highly effective and due to its nature of operation, classified as low risk and not of interest to the TGA here in Australia. (TGA is a part of the Australian Government Department of Health, and is responsible for regulating the import, supply, manufacture, export and advertising of therapeutic goods.)
The product had been selling on Amazon for around 6 months and generating a good level of sales growth when all of a sudden STOP. The US Customs (CBP) seized a shipment and demanded to see the company’s compliance certification.
Previously, shipments had been making their way into the market (obviously under the radar of the CBP) and business was growing. The manufacturer didn’t know about the need for specialised US certification assuming, like in Australia, it didn’t require anything. Consider 6 months of building an audience and establishing the all-important retailer networks, only to then have your product refused entry, returned or destroyed. We have seen a lot of business relationships end for far less.
The manufacturer was at a loss. Finding their way through the maze of compliance was a major barrier to management and far too much time had been spent going nowhere.
The client was eventually referred to CVEN and after some preliminary meetings assessing the issues, our task was clear – “Navigate the compliance hurdles of the US Food & Drug Administration (FDA) and identify the pathway forward.” We love a good technical challenge, so we set to work classifying the product, confirmed its ability to meet US compliance and then outlined to management exactly what the pathway was, what information was going to be required and the costs/timelines that should be expected.
Management had to rethink the US opportunity now as the market demanded more money and a lot more time to secure compliance. The evaluation – Sunk costs (money already spent in the US) and the initial sales growth helped management to confirm the US was worth opening. This time with the approval of the US Food & Drug Administration (FDA).
A new task was awarded the CVEN team. Work directly with management to:
- Obtain the technical information needed
- Collate the submission documents
- Reopen the US market
- Just because it’s OK here, doesn’t mean it’s going to be OK there
- Prioritise your compliance evaluations in the selected destination.
- Resolving an official import refusal notice is more expensive and more challenging than getting it right the first time.
Who is CVEN?
CVEN is an export advisory with a difference. Our team are hands-on and engage internationally with buyers, compliance agencies and logistic specialist on a daily basis. This means the information we provide and the pathways we build for clients are the result of the international business we undertake, everyday.
CVEN is different – we export.