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I am developing a portable device embedding sensors, Bluetooth, MCUs etc.. At present I'm at a prototype stage and I'm starting thinking about production. What kind of certification steps do I need to follow in order to produce and sell it?

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  • \$\begingroup\$ I'm no expert on this so I'm just going to make a short comment. While you might need to follow the ISO 9000 family of standards, you also have to think about the market that your device is targeting. For example, if it's a medical device, you could be required to get FDA certification. \$\endgroup\$ – Dave Apr 14 '11 at 14:25
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The more I learn about regulatory compliance, the more I'm convinced that I don't know anything. This is a giant maze of international laws that is difficult to navigate. What I wrote below is just a rough guide, to be taken with a grain of salt. But my last paragraph is very important: You need professional help (not mental help, that I know of anyway).

There are a variety of regulatory standards that you must adhere to. Most of them are going to center around EMI, Electrical Safety, and Materials Safety.

EMI, or Electro-Magnetic-Interference, is concerned with what interference your box is spitting out and receiving either through the air or through the AC power cable. Spitting out would be EMI Emissions, and receiving would be EMI Susceptibility. Emissions is how your box effects other boxes, and susceptibility is more like will your box work when someone is on their cell phone near by. A somewhat related aspect of this is your boxes tolerance to static electricity zaps. In the USA, this falls under the domain of FCC compliance testing. In the EU, it's part of the "CE" approval process.

Electrical Safety is concerned with things like: will your box burst into flames or electrocute the user. In the USA, this is normally certified by an independent lab, like UL or TUV-- I'm not sure about other countries.

Materials Safety is mostly about the use of lead, but does involve a whole list of bad things. In the USA, I'm not even sure there is anyone who cares what's in the device (as long as it isn't medical or food related). In other countries it's referred to as RoHS or other names, but I'm not sure if that falls under "CE approval" or not.

The important thing to know is this: In the practical sense, you cannot self-certify. Doing this compliance testing involves lots of expensive equipment and knowledge and it's simply not practical to do it yourself. Fortunately, there are companies that specialize in this.

Find such a company, and use their expertise to not only perform the tests, but to give you solid information on the whole regulatory compliance testing/reporting process. In many cases these companies will also file all the paperwork with the various government groups, etc. These companies are often well versed in not only your countries regulations, but also international regulations. I'll warn you that this process is not cheap, and not fast. But that's the cost of doing business.

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  • \$\begingroup\$ +1. I was going to put more in my own answer but the more I thought about it, the more I lost the will to live. It's a horrible minefield of a subject that could well do with simplification and international standardization. \$\endgroup\$ – MikeJ-UK Apr 14 '11 at 16:08
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It depends where in the world you are trying to sell your device. In Europe for example, there are numerous EEC directives affecting the sale of electronic goods, the most well known being :-

  • Electromagnetic Compatability Directive (EMC)
  • Low Voltage Directive (LVD)
  • Waste Electrical and Electronic Equipment (WEEE)
  • Restriction of Hazardous Substances Directive (RoHS)
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  • \$\begingroup\$ First item abbreviation is EMC, not CE. The CE mark implies that the item meets all the relevant directives. \$\endgroup\$ – Martin Apr 14 '11 at 15:23
  • \$\begingroup\$ @Martin - Well spotted & duly corrected! \$\endgroup\$ – MikeJ-UK Apr 14 '11 at 15:27
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If you establish that the device is going to have sufficient sales to cover costs, you should approach a certification agency (UL, CSA, TUV, ETL, MET...) and get a quotation for certification. Certification could easily run into the tens of thousands of dollars.

The Bluetooth part of the circuit will need FCC approval for the USA, Industry Canada approval for Canada (obviously), etc.

Pretty well everything sold (officially) in the China market needs a CCC mark.

If you are including some sort of power supply in the design, you will need it approved by UL or an NRTL for the USA, CSA or a recognized equivalent for Canada, TUV or a recognized equivalent for Europe, etc. - it may be best to require use of an agency-recognized off-the-shelf power supply with the design.

Stuff for sale in Europe and China (and other areas) must be RoHS compliant. This is another external approval.

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There are also the ETSI requirements. I think they are required for Bluetooth in the EU.

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  • \$\begingroup\$ In addition to fulfilling the ETSI EN 300 328 standard, you need to also fulfill the Bluetooth Sertificate in order to use the trademark Bluetooth (logos, mentioning Bluetooth in manuals, etc) in your product. \$\endgroup\$ – user94729 Dec 18 '17 at 5:44

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