Take You to Know Certificates of Teeth Whitening Kit

When many buyers find manufacturers of Chinese teeth whitening kits, the first thing they worry about is whether the manufacturers have relevant certificates and qualifications. As the dental products are different from ordinary daily necessities, they are medical supplies. Therefore, every country has different regulatory standards. For example, for Europe and USA, CE and FDA are indispensable.

In the import and export trade, importers need to obey many regulations, otherwise the goods will be detained in the customs. However, for some product categories, there are some hidden rules that you do not know. Based on my experience, I have summarized the following 5 aspects that many newbies or inexperienced importers often ask me.

  1. Why do buyers import teeth whitening kits from Chinese manufacturers?
  2. What’s the situations of Chinese teeth whitening light and gel manufacturers?
  3. What are the regulatory standards and required certificates of teeth whitening products in China and other countries?
  4. Can’t we cooperate with small factories without some relevant qualifications?
  5. What kind of import qualifications do buyers need to avoid the goods being detained in customs?



1.Why do buyers import teeth whitening kits from Chinese manufacturers?

Lower price

Cheap suppliers are important for business. Taking teeth whitening gels for example, if their capacity is the same , the USA/Europe price is 5-10 times more expensive than China.

Lower MOQ

Especially for some small-scale Chinese factories of teeth whitening supplies, their MOQ is flexible. You can get relatively small MOQ. It’s very friendly to some small business or startups.

Help you mix different products together

Many buyers want to buy teeth whitening kits including teeth whitening box, teeth whitening light, or teeth whitening gel, shade guide and so on.

For example, for a factory that only produces teeth whitening light and gels, you can let them help you to purchase box and put teeth whitening light and gels in one set. And then, they will export them to your country. Otherwise, you will spend more time in purchasing every single goods from different factories, and the cost of teeth whitening kits maybe increases accordingly.


2. What’s the situations of Chinese teeth whitening light and gel manufacturers

In China, teeth whitening lamps belongs to Class II medical device. 99% manufacturers have no relevant producing qualifications, and there are small profit margins for teeth whitening lights. So, very few factories produce it.

As teeth whitening gel belongs to Class III medical device, and its main component is HP (Hydrogen Peroxide), Chinese government controls it strictly. I can tell you that 99% manufacturers have no producing qualifications.

Then, you will be confused about whether the other 1% manufacturers have producing qualifications and can we purchase teeth whitening products from them? However, let me tell you that these 1% manufacturers only  include three factories.

Two of them are large-scale manufacturers, but they generally cooperate with large enterprises, like hospitals and large-scale dental clinics abroad. The other one is a small and medium sized factory, but it has a high MOQ. Besides, its main customers are dental clinics in China, so it lacks export experience.

So, if you are a small-medium businessman, actually your partner of teeth whitening products you are looking for is among 99% manufacturers in China.


3. What are the regulatory standards and required certificates of teeth whitening products in China and other countries

Firstly, teeth whitening light and gels are divided into two categories, one is used for home, the other is used for dental clinic. The main component of teeth whitening gel that is used for home is HP (Hydrogen Peroxide) or CP (Carbamide Peroxide). The regulatory standard in China is that HP content must not exceed 3%. In Europe or USA, content must not exceed 6%, 9%, or12% (different countries have different standards).

The main component of dental clinic version’s teeth whitening gel is HP or CP, which is the same as home version. In order to make the whitening effect faster, the teeth whitening gel of dental clinic version has a higher content of HP or CP. According to European and American regulations, the content of HP or CP is around 12-16%. In China, in  some authorized clinics or institutions, the content of HP or CP can reach 9-12%.

Chinese medical devices are divided into Class I, Class II, and Class III. The higher the level, the stricter the medical control is.

For class I products, like retractors, dental shelf, dental box and so on, the factory just needs to go to customs for filing before they export them to other countries. If manufacturers have CE or FDA, that will be better. For some factories without qualifications, the goods can be exported smoothly once products meet the standards of destination countries,

For class II products, such as teeth whitening light, medical device manufacturing license and filing are required. A filing needs to be made at the local SPDA and then municipal SPDA. It will take 12 months to apply license and filing.  And approximate cost is about $30,000(exchange rate ≈6.5), which is just for registering one product. So many small factories won’t spend so much money in filing every product.

For class III products, such as teeth whitening gels. Medical device manufacturing license and filing are also required, Local and municipal SPDA are also needed, but there is one more step, the NMPA is added. The time required to apply is 1-3 years. If a clinical trial is required, it will last longer. Under such harsh conditions, normally, a small factory would not have this qualification and filing.

So, there are two kinds of manufacturers of teeth whitening products, one is large-scale medical factories and the other is small-medium scale factories. Large medical companies generally produce Class III medical devices or advanced Class II medical devices, which belongs to “1%” companies I mentioned above. Small-medium factories produce Class I medical devices and mid-low end Class II medical devices, which belongs to “99%” companies I mentioned above.


4. Cant we cooperate with some small factories without relevant qualifications?

As you know from the above analysis of teeth whitening products manufacturers’ qualifications, you can only choose to work with 99% small factories in China. Many people are concerned about whether the goods can clear customs smoothly. I’m going to tell you some secrets of  hidden rules.

For teeth whitening light, 99% of the manufacturers don’t have relevant qualifications. China has a relatively loose control over the products and the customs’ supervising is also relatively loose. Some experienced factories are able to export these kinds of products normally.

For teeth whitening gels, Chinese government controls it strictly. At present, the export of gels requires the cooperation between manufacturers with an export capacity and forwarders. Without years of export experience, it is also easy to be detained by customs.

Finally, as I mentioned above, it is easy to export class I medical devices like retractors, dental mirror, dental box and so on.

Large-scale factories have CE, FDA, ISO13485 and ISO9001. For small-medium factories, these certifications costs are very expensive. So importers don’t need to worry, if products quality can reach your testing standards, you will also conclude a transaction. For instance, during the process of Covid-19, Chinese KN95 Civil mask can be exported to many European and American countries.

In 2015, one of my European customers(Introduced by my Hong Kong friend) came to my factory to consult our teeth whitening light. It took about 4 hours to communicate with them. Everything went smoothly. But as we lacked certification, he needed to bring the product back to local testing agency to test.

After waiting patiently for about 15 days, we got the news that the product passed the test smoothly. After we worked hard for nearly 2 months, the goods passed the customs smoothly. And the customers were very satisfied with the goods. We are still business partners now.

As long as the product quality is guaranteed, many buyers will choose to purchase dental products from China. If the buyer needs all the certifications and testing qualifications, then a larger factory is needed to produce them. Accordingly, the procurement cost will be much higher. However, such kinds of factories would not produce such low-margin products.


5. What kind of import qualifications do buyers need to avoid the goods being detained in customs?

Every country has different standards for imported products, you need to check with the local customs about standards before you import products. And then you should ask the Chinese manufacturers whether they can meet the requirements before making orders, which can ensure that risks can be reduced to some extent.


Now it’s your turn

Hope you get information you need about the qualifications of Chinese teeth whitening products.

Or you still have many questions to ask me, you could leave quick comments below. If you are looking for some cost-effective manufacturers of teeth whitening products from the “99%”, feel free to contact us. We can talk about this business together.

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Jeff Le
Jeff from ioralcarel, worked in the Dental industry for over 13 years and guide companies through our Professional Experience. Already help more than 50 clients to get more revenue. Our factory can accept less OEM / ODM MOQ. If you have any questions, you can consult me, maybe there is something more than expected.
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