Pharmaceuticals products and Medical Devices process to export to China

The Chinese Government has always made it clear that they would prefer Chinese consumers to purchase 100% Chinese products only. Which is shocking for foreign pharmaceutical companies is that they dispose of the innovation needed to produce advanced healthcare products whereas Chinese manufacturers lack of this sophistication. But the healthcare needs will tremendously grow in China, considering the rising of living standards and the aging population.

Exporting pharmaceutical products and medical devices to China involves a complex regulatory process overseen by the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA).


  1. Research and Preliminary Preparation: Understand the Chinese healthcare market, including regulatory requirements, market demand, and local competition. This step involves thorough research and possibly consulting with experts familiar with the Chinese market.
  2. Product Classification: Determine whether your product is considered a pharmaceutical, medical device, or health supplement in China, as each category has different regulatory pathways and requirements.
  3. Registration with the NMPA: For medical devices, obtain a Medical Device Registration Certificate. For pharmaceuticals, secure a Drug Registration Certificate. This involves submitting detailed product information, clinical trial data (if applicable), and manufacturing process details.
  4. Quality Management System (QMS) Compliance: Ensure your manufacturing processes comply with China’s Good Manufacturing Practice (GMP) for pharmaceuticals and Good Supply Practice (GSP) for medical devices, which may require adjustments to your current processes.
  5. Clinical Trials: Depending on the product, conducting clinical trials in China may be required. The NMPA has specific guidelines and requirements for trials conducted within its jurisdiction.
  6. Appoint a Legal Agent or Representative in China: Foreign companies must appoint a local representative to handle the registration process and act as a liaison with the NMPA.
  7. Labeling and Packaging Compliance: Ensure that your product’s labeling and packaging comply with Chinese regulations, including necessary information in Mandarin Chinese.
  8. Import License: Obtain an Import Drug License (IDL) for pharmaceuticals or an Import License for medical devices. This step is crucial for legally importing and selling your products in China.
  9. Post-Market Surveillance and Adverse Event Reporting: Implement a system for post-market surveillance and reporting of adverse events, as required by Chinese regulations to monitor product safety and efficacy after market entry.
  10. Maintain Compliance and Renew Registrations: Keep up with regulatory changes and renew your product registrations and licenses as required. The NMPA periodically updates its regulations, and companies must ensure ongoing compliance to maintain market access.

Navigating the regulatory landscape for pharmaceuticals and medical devices in China can be challenging due to its complexity and the frequent changes in regulations. Engaging with regulatory consultants or firms that specialize in Chinese medical product registration can provide valuable guidance and streamline the process.

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Quality healthcare Standard in China

To meet the demand in quality healthcare products, the Chinese government finally decided to operate a certain number of measures in order to encourage foreign investment in the healthcare sector.

China imported $34.1B in Pharmaceutical products, mainly from United States ($6.67B), Germany ($5.55B), Switzerland ($4.63B), Ireland ($2.19B), and United Kingdom ($1.99B). soucre

Overview of the measures taken

As of December 2022, China’s exports of medicinal and pharmaceutical products were valued at approximately $16.67 billion USD. This figure represents a decline from the $41.88 billion USD reported in December 2021. The data, which is updated annually and spans from December 1995 to 2022, shows an average export value of $7.19 billion USD across 28 observations.

The peak of China’s exports in this sector was recorded in 2021, with an all-time high of $41.88 billion USD, while the lowest value was seen in 1996, at $1.20 billion USD. This information is maintained in active status by the CEIC and is sourced from the United Nations Conference on Trade and Development. It falls under the category of “Medicinal and Pharmaceutical Product: Exports Value by Individual Economies and Territories,” as part of the World Trend Plus’s Association: Pharmaceutical and Biotechnology Sector

No need to repeat clinical trials

If an imported medical devices already had a clinical trial abroad that removes the need to do one on the Chinese soil. Before, all imported medical devices that were categorized as Class II or Class III had to undergo a clinical trial in China before they could be used and sold in China.

However, there is an exception for those medical devices that are considered as having a higher risk to the human body. These types of devices still need a separate clinical trial in China, and include cardiac devices, products involving blood pumps, artificial organs and other implantable devices.

Easier implantations for pharmaceuticals companies

The advantage of such a measure is the simplification of the company set-up process. Investors that wanted to manufacture or distribute pharmaceuticals needed to have a Drug Manufacturing License before applying for an Official Business License. Now, investors can apply for these after the company has been set up, which significantly speed up the process. The most important is that it removes all the price controls actions that the Chinese government used to have in place for medicines.

Medical Devices advertisement

There has been a restraints on advertising healthcare products. Advertising for anaesthetics, psychotropic drugs, toxic and radioactive drugs for medical use is absolutely not allowed and it is the same treatment for drugs or medical devices to fight drug addiction. Advertising for prescription drugs other than the previously mentioned is only allowed in professional medical journals.

Health foods should be advertised as having medical benefits, and cannot claim that they are diseases’ healers or necessary to maintain good health. Media companies such as TV channels, radio shows or websites may not advertise medicines, medical devices or health foods under the guise of giving health and lifestyle advices.

A growing market

Connected medical and also cosmetics devices is a growing market in China, with different actors popping every time. Chinese manufacturers of connected devices seems entitled to take over the market. For example, Xiaomi, one of the most important Mobile Company in China, recently launched iHealth, a device which calculate your tension.

A Chinese manufacturer, Viatom Technology, claim that they can measure the arterial pressure without any physical touching. Health costs in China are extremely high and a large part of the population cannot afford proper medical care. That is why the arrival of such products could really help revolutionize the way they heal themselves.

Moreover, Chinese consumers are super connected and having all their medical information available on a smartphone app would be a life changer.

The market needs to be tapped as the demand is growing and these companies need to use social media to communicate and reach their customers. It’s the best way to increase your brand awareness.

Read more

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