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China CFDA Registration

The People’s Republic of China is the world's fastest growing market for health care and beauty products and offers tremendous business potential for international manufacturers of medical devices, pharmaceuticals, and cosmetics.

Entry into the Chinese market can pose a challenge due to complex regulations, language barrier and intense competition. Cisema has handled hundreds of projects and can help you comply with China CFDA's requirements.

What is the China CFDA Registration?

It is a registration procedure of the Chinese legislation CFDA (China Food and Drug Administration), in which the following product categories are certified according to guidelines:

  • Medical devices (including IVDs)
  • Cosmetics
  • Pharmaceuticals, pharmaceutical packaging and ingredients
  • Infant Formula
  • Health Food (Nutritional Supplements & Food with Specific Health Functions), and
  • Food for special medical purposes

CFDA approval was introduced by the Chinese legislation after identifying opportunities in the system in the face of globalization, increasing international competition and in efforts of harmonizing with other international standards. The import, sale and use of the aforementioned products is only allowed with valid CFDA registrations in favour of quality assurance and product safety. To learn more about China CFDA registration, explore each product category.

What regulations are in place regarding the China CFDA registration?

For not only first-time applicants, but business veterans alike, the ever-changing legislation and expanding regulatory requirements can prolong the registration process. This is due to the legislation for CFDA approval for certain product groups was only recently introduced and is therefore constantly reevaluated.

The regulations for the CFDA registration

  • GB Standards (Guobiao, Chinese for "National Standard") and
  • YY standards (derived from the Chinese word for medicine, "industry standard")

have similarities with international (EU, United States, et.c) standards. However, these guidelines are supplemented by Chinese-specific requirements. Previously obtained ISO standards could aid the registration process but are not mandatory. Companies may obtain further information on CFDA regulations and regulatory requirements by requesting our brochures.

What is the NMPA?

Over the years, China’s regulatory body for life science products has changed its structure and name multiple times. It was known as SDA (State Drug Administration), SFDA (State Food and Drug Administration), and CFDA (China Food and Drug Administration).

On 13.03.2018, during the 13th National People's Congress, China’s cabinet decided to rename the CFDA once more to NMPA (National Medical Product Administration). Also during this congress, the number of ministerial-level departments was reduced and the SAMR (State Administration for Market Regulation) was established to supervise the NMPA, AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), and SAIC (State Administration for Industry and Commerce). The related regulations and civil servants in charge of registrations remained the same.

Our website and brochures still utilize the term CFDA until the public is more familiar with the new term NMPA.

  • Avoid mistakes during your CFDA registration process, and benefit from our extensive years of experience and large client network.
  • With 9 office locations worldwide, we are always at your disposal, mitigating effects of timezones and business hours.
  • Avoid unneccesary setbacks due to language barriers and cultural differences. Cisema is intercontinental with offices in Europe, Asia, and North America.
  • We maintain healthy long standing relationships with the Chinese authorities within the framework of our Code of Conduct.
  • We support you with our technical know-how and strive for seamless project progression within your timeline.
  • We will constantly keep you updated regarding changes to regulations, so you can stay one step ahead.

einschließlich IVDs

Medical Devices

Cisema kann für Unternehmen, die eine CFDA Zulassung für Medizinprodukte anstreben, ein komplettes Spektrum an Dienstleistungen anbieten und somit den geeignetsten Weg zur CFDA Zulassung in China für Ihr Produkt sicherstellen.

"non-special" und "special" Kosmetika

Cosmetics

Eine China CFDA Registrierung ist aufwändig und kann, je nach Produkt, zwischen wenigen Monaten und einem Jahr dauern. Die Kosten und der genaue Zeitrahmen für eine Zulassung richten sich unter anderem nach der Klassifizierung und den in China auszuführenden Tests.
In China wird zwischen "Special" und "Non-Special" Kosmetikprodukten unterschieden.

Verpackungen und Inhaltsstoffe von Arzneimitteln

CFDA Registration of Pharmaceutical Packaging and Ingredients

Am 10.08.2016 hat die CFDA die kombinierte Registrierung von Verpackungen und Inhaltsstoffen in Kombination mit der Registrierung von Arzneimitteln eingeführt (Mitteilung Nr. 2016-134).

Lebensmittel für besondere medizinische Zwecke

Infant Formula

Am 23.11.2017 veröffentlichten CFDA und AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) eine Bekanntmachung über die Registrierungsanforderungen für importierte Säuglingsmilchnahrung (für Kinder von 0 bis 36 Monate).

Health Food

Health Food

Am 10.08.2016 hat die CFDA die kombinierte Registrierung von Verpackungen und Inhaltsstoffen in Kombination mit der Registrierung von Arzneimitteln eingeführt (Mitteilung Nr. 2016-134).

Food for Special Medical Purposes

LBMZ-Products

Am 23.11.2017 veröffentlichten CFDA und AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) eine Bekanntmachung über die Registrierungsanforderungen für importierte Säuglingsmilchnahrung (für Kinder von 0 bis 36 Monate).

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.

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