Country certification marks are designed to help countries regulate the products that are manufactured in or imported into their country for sale. In general, the marks are designed to regulate the safety standards of different products sold across borders. Unfortunately, these marks were developed by different nations independently of each other so there is little continuity between the standards and the way the regulations are formatted can cause confusion. This article is designed to help you better understand what these marks mean, how to approach the process of applying for your required mark, and what the consequences are of non-adherence, especially as they relate to electronic devices used in clinical trials.
What do the marks mean? How do you know which ones are required?
Country certification marks for electronic devices like cellular telephones, are designed to ensure that products do not emit unwanted electromagnetic pollution in the environment and that they are immune to a reasonable amount of interference. The marks signify that a certain product meets the health and safety guidelines of a given country so that the product can be marketed and sold in said country. Most nations have their own requirements and depending on where you need your devices shipped, you may need a lot of knowledge about the different marks before you get started.
Below are some of the most common marks:
- Americans will be most familiar with the FCC mark. The Federal Communications Commission (FCC) is an independent United States government agency that is directly responsible to Congress. All manufacturers or importers with devices that operate at a clock rate of 9 kHz are required to test their products to the appropriate FCC Code. The FCC mark is often paired with the UL mark and/or the ROHS mark to ensure safety compliance.
- In Europe, this has been all rolled up into one set of standards called the CE mark. The CE mark is the equivalent of the UL safety testing andFCC testing. Likewise, the medical testing is controlled by the EMEA (European Medicines Agency), but the compliance is rolled into the CE mark, too. The European Commission describes the CE mark as a “passport” which can enable manufacturers to advertise and sell industrial products freely within the EU market. Some non-EU members have also adopted the CE mark, usually in conjunction with their own certification. Once a product receives the CE mark, it can be marketed throughout the EU without undergoing any further modifications.
- Another common mark is the Chinese CCC Mark or China Compulsory Certification. This marking system requires manufacturers in over 132 product categories to obtain the CCC Mark before exporting to or selling in the Chinese market. Products not meeting “CCC” requirements may be held at the border by Chinese Customs and will be subject to other penalties.
These are three of the most known certification marks but almost every nation has their own set of rules and regulations that anyone looking to deploy devices in each region would need to adhere to. Vessel keeps track of the marks for over 135 countries, several of which require more than one mark. Our advice is to narrow down which countries your clinical trial will be operating in first and then choose your devices based on what certifications you need.
What is the application process?
Manufacturers are not responsible for applying for the CE mark if they are not the importers. Importers must secure the mark before shipping the product. It usually takes one month for CE certification. Many directives require products/systems to be independently certified; this must be done by a “Notified Body,” an organization that has been nominated by a Member Government and notified by the European Commission. A Notified Body may be a private sector organization or a government agency. Manufacturers/importers may choose a Notified Body in any member state of the European Union.
The FCC application also takes about one month to complete and requires that certain emissions tests be performed on electronic equipment. It requires an accredited laboratory like MET Laboratories measure radio frequency energy from the device to ensure that it meets relevant technical standards. These electronic devices must be tested to show that they do not cause harmful interference to other devices and that they can withstand a reasonable amount harmful interference from other devices.
For the Chinese CCC mark, the application process may take sixty to ninety days or longer and requires testing at an accredited Chinese laboratory. This process calls for the submission of numerous technical documents, product samples, and factory inspections by Chinese officials.
What are the consequences of non-adherence?
EU customs can request CE certification documents to prove that the imported items are compliant with all applicable CE directives. If the importer cannot produce the requested documentation (product certifications and technical documentation), the customs authorities will refuse to allow the shipment to enter and ultimately cause a delay in a project, possibly missing first patient visit.
In China, authorities may continue to pursue certifications after the products have made it through customs. If these certifications can’t be produced to prove compliance then the authorities can force a recall of all products in that shipment.
The FCC has the power to seize goods, hand out fines, and even recommend jail sentences to offenders. If FCC regulations are ignored or avoided, then the person (or company) that sells the non-compliant device has violated the FCC marketing rules as well as federal law and may be subject to an enforcement action by the Commission’s Field Operations Bureau that could result in:
- forfeiture of all non-compliant equipment
- $100,000/$200,000 criminal penalty for an individual/organization
- a criminal fine totaling twice the gross gain obtained from sales of the non-compliant equipment
- an administrative fine totaling $10,000/day per violation
With today’s market trends, more and more clinical trials are being conducted in underdeveloped regions. As such, any devices deployed for data collection would require some of the lesser known certification marks. This process can be complicated so it’s best to make sense of the chaos by consulting or partnering with a device expert like Vessel that can help you understand what certifications you need and guide you through your application process.