NMPA regulation and registration of cosmetics, pharmaceuticals products, drugs and medical devices in China

• In 2013, the State Food and Drugs Administration (SFDA) was renamed China Food and Drugs Administration (CFDA). It becomes the authority in charge of the surveillance and safety of 4 major categories of goods: foodstuffs, medicines, medical devices and cosmetics.

• Since 2018, a reform of the administrations has led to the following reorganization :
  
  
  
  

  		The NMPA replaces the CFDA as the supervisory authority for 3 product families : medical devices, drugs, pharmaceuticals and cosmetics.
  It is a separate entity under the direct supervision of the SAMR (State Administration for Market Regulation). NMPA has 11 departments in charge of products approval, inspections and regulation development. It supervises 31 provincial offices in charge of regional affairs. The Shanghai office is called SMPA (Shanghai Medical Products Administration).

• Foodstuffs remain under the integrated control of the CFDA (China Food & Drugs Administration).
  

a. Functions at national level and areas of monitoring

• Elaborate and develop laws + regulations in the medical and pharmaceutical sectors
• Issuing approvals & related licenses and certificates for companies, products and individuals
• Supervise companies, qualified individuals and products
• Organize controls, inspections and take actions aganst the serious infringements.
  
  
  

b. The role of NMPA in enforcing market control

The supervisory attributes of NMPA are applicable to all China registered companies that import, export or manufacture the following products :

• Pharmaceuticals and drugs
• Cosmetics
• Medical devices and apparatus.

Its supervision power reaches all types of companies : domestic invested companies, fully owned foreign companies or subsidiaries (WFOE, LLC) and sino-foreign joint ventures.

The Chinese authorities indicate that an operator in these sectors must hold additional licenses or hygiene permits in order to conduct the activity. A mandatory registration must be conducted with the NMPA in order to certify a product according to the national guidelines.

The applicable process and formalities vary depending on whether the operators are local manufacturers, importers or resellers. They are a prerequisite for carrying out compliance and authorizing marketing.

Please note that these procedures are not to be confused with the customs registration procedure (GACC) for a foreign manufacturer, exporter or importer. Here are some representative examples below.

4. Regulation and registration of cosmetics

a. Evolving Chinese regulations for compliance

For this market, which has become strategic for international brands, since 2018 there has been a standards program that applies to cosmetics and beauty care products distributed in China. Since 2021, the regulations apply not only to exported goods, but also to those produced on Chinese soil. This new cosmetics supervision and control regulation is known as the Cosmetics Supervision and Administration Regulation （CSAR).

Since May 2022, exporters who had previously filled in this information have had to transfer and then complete their previous declarations on a new version of the online platform. Migration of previous declarations is not automatic, as they are often insufficient.

The demanding CSAR regulations also list authorized components. The requirements for approval and marketing authorization differ according to whether the product is intended for a specific use or an ordinary use.

b. Cosmetics are classified into 2 main lists or categories in China

Specific-use cosmetics and treatments : those with an active effect. For example, hair growth or dyeing products, hair removal products, fitness products or breast shaping products. This category also includes deodorants, serums for spot removal, skin whitening and sun protection creams. Preparations belonging to this class are subject to a prior approval procedure for full registration.

Other general cosmetics : These include hair care products, moisturizers, skin care products, nail care products, perfumes and make-up. The registration procedure for preparations falling within this list is simpler, based on a declaration followed by a series of tests.

The formalities are nonetheless demanding in their precision and thoroughness. This applies in particular to the manufacturer's laboratory certificates, the Good Manufacturing Practice (GMP) certificate to provide, exporter's declarations, letter of appointment of responsible persons. The NMPA also requires that a Domestic Responsible Agent ("DRA") is nominated as the liable entity in China for all quality matters.

c. Liability requirements and labeling rules

Frequently updated, the latest regulatory measures came into force on May 1st, 2022. Among the requirements, exporters have a reinforced responsibility obligation in the global safety chain. Managers of foreign manufacturing sites must be designated.

In the event of non-compliance, NMPA sanctions are graduated. Warnings, confiscation of stock, fines and penalties, business suspension orders, revocation of licenses and certificates. Count also the impact of sanctions on the company's administrative reputation (corporate social credit). The competition will not fail to relay this information, which has become public knowledge, in cleverly orchestrated denunciation campaigns.

Mandatory information on labels (in Chinese) includes : name and brand, approval number issued by the NMPA, contact details of the manufacturer (or importer) in China, ingredients, weight, use-by date, instructions for use and safety warnings.

 

d. Registration formalities and certificates or licenses to be obtained

These vary according to the operator concerned, and the nature and declared functions of each care product. Here are 5 examples of certificates or licenses to be obtained depending on the case :

d.1 : Approval and certificate for new cosmetics not yet distributed in China. It is up to the foreign manufacturer or exporter to apply to the NMPA. The procedure takes place in 2 stages : meticulous registration with a view to opening an NMPA account, followed by tests to be carried out in China. A complete file must be prepared, including a very detailed presentation of the product, its composition and ingredients, its packaging and its brand in Chinese language. Some documents must be notarized. In China, a local agent must also be appointed and authorized. This is known as the DRA (Domestic Responsible Agent). He may be the importer or another entity. This subject needs to be carefully evaluated and compared. Once the tests have been validated, a certificate of conformity will be issued in the name of the custodian (exporter or manufacturer).

Example of an NMPA registration certificate for a cosmetic cream Here is an extract from the official digital version. It authorizes the marketing in China of a beauty cream made in France. This certificate was issued by the NMPA on behalf of the French lab, manufacturer, also applicant for approval. It contains several pages. This extract only illustrate few basic mentions.

d.2 : Approval of new ingredients in cosmetics. In the event that an already-approved product undergoes a change in formulation or ingredients. The foreign manufacturer or exporter must declare these modifications.

Please note : all the ingredients in a cosmetic product must be listed by their laboratory of origin. This detailed list, which breaks down the formulation, forms part of the preparatory file for approval. The ingredients must already exist in China and must be included in a list of authorized ingredients. Otherwise, each new ingredient shall be approved first. The current list is an NMPA database known as the Inventory of Existing Cosmetic Ingredients in China (IECIC). It is regularly updated with new, approved ingredients. Each registration file requires verification for approval.


d.3 : Import license for all foreign cosmetics and beauty products with or without a specific use.

d.4 : Production license (when made in China). The manufacturer must apply for this license.

 

China market stats for foreign cosmetics manufacturers and exporters Cosmetics consumption in China Market size in 2022: 85 billion USD. 23% of total world market. No. 1 market in Asia, ahead of Japan. Consumption growth: 2012-2022: +200 Import growth: 2015-2022: +435% Import segmentation: creams and make-up (84%), fragrances & perfumes (4.5%), hair care (4.4%). Distribution segmentation: in-store (56%) + online (39%) still growing.

5. Classification and registration of medical devices

a. Classification based on the level of risk

China uses a risk-based three (3) tier classification system. Class I includes low risk medical devices, Class II moderate risk apparatus and Class III high risk equipment.

b. An approval or licenses depending on the classes

• Licensing and registration of medical devices manufactured in China
• Registration or license for imported devices

 

Guide : 2024 regulations for marketing medical devices in China Here's a regulatory overview that presents the three classes and the level of requirements for their qualification. This classification is common to both overseas and locally made products. It therefore applies to all Chinese and foreign operators. Class I : they are those that present a low risk to the patient and are simpler in design and operation. Examples include bandages, canes, crutches, prescription spectacles, medical thermometers, certain healthcare face masks, etc. The requirements for the approval procedure for Class I devices remain fairly summary. A registration is sufficient, no need to apply for a dedicated license. Class II : they include those that present a moderate risk to patients. They require more control to ensure their safety. Examples of Class II medical devices include dental prostheses, certain contact lenses, MRI equipments, medical scanners, cardiac monitors, certain catheters, insulin pumps, blood pressure monitors, etc. These are for reference only and not exhaustive. Their approval and testing require a license (certificate). Valid for 5 years and renewable. The formalities and stages are longer and more procedural. Class III : they are those considered to present the highest risk to patients. They require the most stringent qualifications and controls. Examples include pacemakers, hip and knee prosthesis, defibrillators, heart valves, ventricular assistance devices or deep neurostimulation devices. The approval process and controls for Class III medical devices also involve the deliverance of a license valid for 5 years. The associated administrative formalities are the longest and most procedural. At sight of its high-risk classification, a device in this class requires clinical trial approval, to be conducted in one or more certified Chinese testing laboratorie(s). Tests for all devices in the last 2 classes must be carried out in China. Unless exempted, clinical evaluation tests must also be carried out in China, in accordance with applicable chinese GB standards. Please also note that the administration requires the appointment of a domestic responsible agent (DRA) who is confirmed as the locally responsible intermediary with the Chinese authorities. The choice of this agent is not insignificant, as he or she must be professionally qualified. In most cases, an importer or distributor will offer to act as this agent. However, companies with a distribution subsidiary in China prefer to keep this function, in order to limit dependence on an external partner. This translated certificate example was issued in June 2023 for a medical scanner (class II). The authorities requirements are both administrative and technical. The whole process of obtaining a license to market a product takes between 5 and 6 months. Depending on test results, it is realistic to expect 1 year or more for Class III devices. Forecast 1 year and more for Class III devices is realistic, depending on the the testing program the device will require. Since April 2022, a national directive has required Chinese hospitals and care centers to give priority to purchasing Chinese or Chinese-made devices. Business opportunities remain, however, for foreign manufacturers offering devices with proven added value. In this case, they will still find markets in China and conduct the formalities to have their products approved. We observe that foreign manufacturers tend more and more to produce through a China subsidiary the references of devices that they wish to market locally. The China purchasing process for such devices often follows calls for tenders.

 

6. Registration of drugs and pharmaceutical products

 

Approval + registration of pharmaceuticals made in China Registration of pharmaceutical preparations imported Approval for the import and marketing of vaccines Approval for the import of narcotics and psychotropic drugs Certification of manufacturers of radiopharmaceuticals Other formalities based on uptodate regulations.

 

 

 

 

 

 

The product families presented in the above sections are non-exhaustive examples. Your products should be meticulously classified according to their exact nature and function, to ensure they meet the NMPA requirements in force.

• Regulatory reviews and draft files for distribution of medical, pharmaceutical, food, dangerous or highly regulated products.

• Regulations monitoring + registration and licenses for food, drugs, beauty and medical products.
  
  
• Customs (GACC) registration for overseas exporters and manufacturers.
  
  
• Market analysis, pricing, positioning and competition survey reports.
  
  
• Products compliance review in the context of a search for a China agent or distributor.
  
  
• Feasibility reports for foreign invested projects and comparison of setup conditions in several locations.
  
  
• Negotiation service assistance following denunciations or disputes with the authorities.
  
  
• Incorporation of foreign owned LLC companies (ex-WFOE) + related licenses & permits.
  
  
• Handle logistics & warehousing solutions : optimize the products flow hanlding and distribution fluidity.