China NMPA Registration

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China NMPA 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 NMPA's requirements.

What is the China NMPA Registration?

It is a registration procedure of the Chinese legislation NMPA (National Medical Products Administration, former 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)
►      Food for special medical purposes

NMPA 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 NMPA registrations in favour of quality assurance and product safety. To learn more about China NMPA registration, explore each product category.

What regulations are in place regarding the China NMPA 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 NMPA approval for certain product groups was only recently introduced and is therefore constantly reevaluated.

The regulations for the NMPA 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 NMPA 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.

  • Avoid mistakes during your NMPA registration process, and benefit from our extensive years of experience and large client network.
  • With 11 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.

including IVDs

Medical Devices

Cisema can provide a full range of services to companies seeking NMPA approval, ensuring the most appropriate route to NMPA approval in China for your product.

"non-special" and "special" cosmetics

Cosmetics

A China NMPA registration is complex and can take from a few months to a year, depending on the specific product. The exact costs and the timeframe for the registration depend, among other things, on the type of cosmetics and the tests to be carried out in China.

Pharmaceutical Packaging and Ingredients

NMPA Registration of Pharmaceutical Packaging and Ingredients

On 10.08.2016, NMPA initiated the combined registration of pharmaceutical packaging and ingredients together with pharmaceuticals.

For children from 0 to 36 months

Infant Formula

On 23.11.2017, NMPA and AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) published a notice on the registration requirements for imported infant formula.

Health Food

Health Food

Food with an additional health benefit is regarded as Health Food and is divided into two categories: Nutritional Supplements and Food with Specific Health Functions.

Food for Special Medical Purposes

FSMP-Products

The NMPA follows national standards (GB 29922-2013) and classifies Food for Special Medical Purposes (FSMP) into four categories: Nutritionally Complete Foods, Nutritionally Complete Foods with a Specific Formulation, Nutritionally Incomplete Foods, and FSMP for infants.

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