Navigating Regulatory Landscape-6 Tips & Tools for Faster Market Entry

So, you’ve just been advised that your product will be offered globally. In today's rapidly changing business landscape, obtaining international approvals can be challenging and time-consuming, causing delays in your business expansion plans.

Don’t panic… Here are 6 best practices for international approvals to get that product to market.

1. Set a timeline and cost expectations with sales and engineering
   Understanding what it’s going to cost to obtain certifications in your target markets is key and can help you to focus on the country list.
   
   
2. Focus and prioritize the target country list
   What are your priority countries? Identify these based on expected sales, existing presence in the country, and orders received. Common prioritization methods:
   • Tier 1, Tier 2, Tier 3
   • Initial, secondary, rest of world, etc.
   • By region
3. Understand your product
   Ensure you have a product datasheet or technical specification as early as possible in the process. Ask yourself these questions:
   • Have I created a product model number?
   • Do I have the correct HS Code for my product for each market?
   • Does my product have a power supply?
   • Does my product contain an RF module?
   • Do I have the necessary EMC, Safety, and Radio test reports for my product? Or plan to obtain them?
   • Where is my product made? Do I know the factory location(s)?
   You would be surprised how many manufacturers aren’t prepared to answer these types of questions. 
   
   
4. Identify and engage appropriate teams early 
   The Regulatory Compliance Engineer or PM may be the person managing the overall process for obtaining international approvals, but input from many teams will be required, so it’s helpful to identify these contacts early in the process. And make sure they are aware of what contributions will be required.
   • Engineering
   • Sales
   • Manufacturing
   • NPI Team
   • Logistics/shipping
   • Documentation
   • Management
   • Authorized Signatories
5. The devil’s in the details
   International Approvals is a documentation-heavy endeavor. The smallest details matter, so it’s imperative that documents are clear, concise, and consistent. 
   Pay close attention to the following:
   • Manufacturer Name and Address
   • Brand Name
   • Applicant Name
   • Product Model Number
   • Factory Addresses
   These should be consistent across all documentation, including test reports, ISO certs, Business Licenses, etc.
   Another tip: Product photos must be high definition, high quality, and property labeled for easy identification. 
   
   
6. Expect the unexpected:
   While we may be used to doing certifications for the US, Canada, and the EU, other countries have unique requirements and expectations that can come as a surprise. Here are a few to keep in mind:
   • Local representation: many countries require local representation
   • Document signing and stamping: many countries require documents, application forms, letters of authorization, etc., to be physically signed.
   • Customs and shipping: expect delays when shipping samples or documents to some countries and build those delays into your project timelines.

How Nemko can help

With our extensive local and global connections, coupled with our bilateral agreements, Nemko offers the perfect solution for your business to obtain accelerated market access for your product.

View our infographic on the top 6 tips and tricks for faster market entry!