NMPA Registration and Approval for European manufacturers
CCG can help European manufacturers to register for NMPA Approval (formerly known as CFDA certification or SFDA approval).
On this page you will find links to all the information you need about the National Medical Products Administration approval process
(such as which medical devices need it, how much does NMPA certification cost, which type of NMPA approval services CCG offers, etc…)
Why the NMPA Approval?
The People’s Republic of China has become, throughout the years, a highly attractive and major market for medical devices and product manufacturers. In 2012, the valuation of the Chinese market for medical devices reached over 25 Billion Dollars (US).
With China’s extensive population becoming more health conscious, their willingness to spend money on health care has increased and high double digit sales growth rates have been recorded year after year. According to CAMDI (the China Association for Medical Devices), more than 60
percent of the current medical equipment is technologically obsolete using 80 year old technology or even older. All of these factors combined with steadily growing acceptance of the Western medicine, viewed as complimentary to the Traditional Chinese medicine, makes the Chinese markets potential huge.
Due to the changes in both Chinese population and the healthcare industry they are willing to improve their quality of care. As a result China turned into the number one market for European and international manufacturers of medical devices and products.
The NMPA is responsible for the registration of medical devices for the Chinese market. All medical devices have to be classified by the NMPA according to its risk in three classes. Depending on the risk classification, there are different requirements:
• For medical devices of class I: product tests are sometimes required
• For medical devices of class II: product tests are always required and clinical trials are sometimes required
• For medical devices of class III: product tests are always required and clinical trials are always required (source Wikipedia NMPA)
To get a full overview of medical devices included, check out our NMPA Classification Overview.
Frequently Asked Questions
How much does NMPA approval cost?
While the approval for Class I medical devices usually takes 6-9 months to complete, the approval for Class II medical devices takes 10-12 months; the approval for Class III medical devices can often requires 12-18 months or more due to the clinical trial. The complexity of the device, its usage and risks determine the costs and time needed for approval.
Other factors having an influence on the cost and the time frame:
- Number of products to be tested.
- Necessity to implement company or product standards.
- Scope of consulting required for labeling of the product(s).
- Requirement for an after-sales agent or support in China.
- Amount of product documentation needed for language translation.
- Extent of product tests according to Chinese GB Standards.
With professional support for your CFDA approval, many costly problems can be avoided in advance. With expert guidance, strategic planning and on-going support the CFDA approval process can be managed in a timely cost-effective manner. CCG Testing & Certification B.V. – China Certification Group offers an all-inclusive package for CFDA certificationassuring optimal time and monetary efficiency.
Do you want to know more about CFDA registration? Please contact us directly!
Our services are customized to individual customer needs and are 100% transparent. All costs associated with CFDA registration and included, even potential fee or exchange rate increases.
Which products need NMPA approval?
Medical devices for the Chinese market are classified into three different classifications by CFDA. The three classifications are categorized as Class I, Class II, and Class III. For each class, specific administrative procedures, product tests and/or even clinical trials may be required for the approval process.
- For Class I devices, safety and effectiveness can typically be ensured through documentation, so product tests and clinical trials in China are usually not required.
- For Class II devices, safety and effectiveness can be ensured through documentation and product testing. Some Class II devices may require clinical trials.
- Class III devices which are usually imbeded into the human body or are used for life support or sustenance, can pose a potential risk to the human body and are strictly controlled by mandated tests and clinical trials to ensure their safety and effectiveness.
It can be difficult for medical device manufacturers to determine whether their products require certification and in which class their products should be categorized. For more information about the three different classifications, please feel free to contact us!
You can read the complete Rules for Classification of Medical Devices on the official CFDA website.
Sometimes evaluating in which class your products belong or even if they need certification can be difficult for manufacturers. That’s where CCG comes in to help you in this process. Contact us at 31 6 14 71 12 06 to request a Free consultation.