The NMPA differentiates between "non-special" and "special" cosmetics

Cosmetics

A China NMPA approval is complex and can take from a few months to a year, depending on the specific product. The exact costs and the timeframe depend, among other things, on the type of cosmetics, the ingredients and the tests to be carried out in China. In China, a distinction is made between "special" and "non-special" cosmetics.

  • "Special" cosmetics are subjected to more extensive testing as part of the registration. Products include: deodorant, sunscreen, hair dye, depilatory, whitening (direct translation "spot removing"), as well as remedies targeting hair growth, hair perming, breast beauty, and body slimming.
  • Manufacturers of "non-special" cosmetics have to undergo a new filing method as of November 2018. More details on the filing procedure can be found in our cosmetics brochure.
  • Baby cosmetics are not considered as a separate category; however, as soon as a product targets babies or children, the cost and the timeframe for the registration tend to be higher due to additional sample tests.

The process of China NMPA filing ("non-special" cosmetics) and registration ("special" cosmetics) is demanding. Even large companies make mistakes. Cisema provides solutions customised for your products. Our experienced consultants guide you through the entire regulatory process in China until receipt of certificate, including identifying whether your cosmetics are "special" or "non-special", analysing the formula and packaging for China conformity, and preparing the application documents in Chinese. The NMPA certificate for "special" cosmetics is valid for 4 years, while the certificate for "non-special" cosmetics is valid indefinitely. Learn more about the process of China NMPA filing and registration including timelines in our brochures.

According to NMPA regulations, foreign cosmetics applicants shall appoint a CRA for “special” cosmetics and a DRA for “non-special” cosmetics.

A CRA is only responsible for the registration, supervision of the tests and administrative aspects during the registration application. It is important to know that the responsibilities of the DRA for "non-special" cosmetics are more extensive and go beyond the filing including import, management of products, as well as joint responsibility for product quality and safety (post-market  surveillance).

The CRA or DRA must be a legal entity in China and applicants usually have three options:

  • Company’s subsidiary in China
  • Distributor
  • Independent professional partner like Cisema

Cosmetic companies who want to appoint a Chinese distributor as CRA or DRA should be aware of the advantages of an independent professional partner compared with a distributor. When using a professional partner, such as Cisema. Cosmetics applicants preserve full control over their NMPA online account, its maintenance and the hardcopy or electronic certificates. Certain confidential information, such as the production process, is not shared with distributors. Cosmetics applicants preserve the flexibility to change and add distributors at any time.

  • Cisema can assume the role of CRA for the registration of “special” cosmetics
  • Cisema can assume the role of DRA for the filing, import, management of products, and joint responsibility for product quality and safety (PMS) for “non-special” cosmetics:
  • Apply for and manage the NMPA (National Medical Product Administration) filing system online account.
  • Facilitate the communication between the Beijing MPA (Medical Product Administration) and the foreign manufacturer.
  • Establish a product quality and safety management and records system together with the foreign manufacturer.
  • Convey relevant regulation changes to the foreign manufacturer truthfully and accurately.
  • Coordinate the import of the product and maintain sales records in China.
  • Create the annual inspection report to meet the annual checking requirements of NMPA.
  • Store product samples and records at the DRA office site for potential official Beijing MPA checks.
  • Receive information on adverse events due to quality related issues and provide feedback to the foreign manufacturer and report back to the related department of the Beijing MPA.

Request our service offer if you would like to nominate Cisema as your CRA or DRA.

Are you a manufacturer and want to sell your cosmetics in China for the first time?

You may already sell your cosmetics in China online via CBEC but now wish to enter China via the general trade?

Are you unsure if your ingredients are China compliant?

Would you like to know how much time and costs you have to anticipate for the China NMPA registration or filing of your cosmetics?

Are you unsure who to appoint as your local responsible person - China Registration Agent (CRA) or Domestic Responsible Agent (DRA)?

Wondering how many test samples you need to provide to Chinese laboratories?

Would you like to know if the packaging of the test samples must already look like the final product?

Do you have any concerns about revealing the exact manufacturing method and ingredients of your cosmetics as part of the registration?

You may already have certification for your cosmetics, but will it expire soon?

You don't know how a recently released regulation affects you?

Do you have a question regarding the QMS (quality management system) requirements in China?

Which services can Cisema support you with?

Cisema offers a full scope of services to companies seeking NMPA approval, ensuring the most efficient route to China NMPA filing and registration for your cosmetics:

Ingredient Check

  • Single ingredient check
  • Formula check
  • New ingredient registration obligation introduction
  • Send your request now

One-stop service offer for cosmetics filing/registration in China:

  • Category check ("special" and "non-special")
  • Full-cost calculation including timeline
  • “Non-special” cosmetic filing
  • “Special” cosmetic registration
  • Ingredients, claims and packaging review for compliance with Chinese regulations
  • Provision of document checklist and templates, including review and advice on the correct completion of the registration documents
  • Test sample import and logistics
  • Test arrangement and coordination in China
  • Translation and notarization of documents into Chinese
  • Chinese label drafting according to NMPA requirements
  • NMPA application dossier preparation and submission
  • Support the technical review and respond to supplementary dossier
  • Responding to supplementary notice
  • Handover of NMPA certificate
  • Close follow-up and timely response during the whole filing/registration process
  • Advice on applicable legislation and relevant regulations
  • Post-approval regulatory support, e.g. change applications, DRA changes, and renewals

We preferably support companies from the start of the application process, as we believe that major mistakes can be prevented right at the beginning of the China NMPA registration process. Errors in the application usually lead to significant delays and increase in effort and expenses for the applicant.

Find out how we can help your market entry into China. To obtain further relevant information, we recommend our exclusive brochures.

We are at your disposal

Contact

Do not hesitate to contact us if you have further questions or to request a non-binding offer.
You can contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email.

To obtain further relevant information we recommend you
to visit our knowledge area or our registration page for exclusive information brochures.

TOP