医美器械中国NMPA认证代理服务
Thai medical beauty equipment has become extremely popular in Southeast Asia in recent years, with advanced and durable technologies ranging from water-based needles to laser hair removal devices. But many Thai manufacturers have encountered difficulties when trying to enter the Chinese market: “The NMPA certification of the China National Medical Products Administration is too complex, with a bunch of requirements for testing reports, clinical data, and registration processes. What should we do? ”Don’t worry! Our team has helped more than 20 Thai medical beauty equipment companies obtain certification, summarized a set of practical strategies, followed the steps, and even small and medium-sized manufacturers can easily clear customs!
1、 Why is NMPA certification a “life or death” barrier for medical beauty devices entering China?
According to Chinese law, all imported medical beauty devices must be certified by NMPA (National Medical Products Administration) and obtain a “Medical Device Registration Certificate” before they can be sold. Whether it’s large laser equipment or small beauty needles, can they be put on shelves without certification? A fine of 500000 RMB may be imposed, and criminal liability may be imposed in severe cases! There was a Thai water light instrument manufacturer who approached a Chinese agent to deliver goods without certification, only to have their goods detained by customs and put on a “blacklist” where they could not apply for certification for three years. So, certification is not a multiple-choice question, but a mandatory answer!
2、 NMPA certification is divided into three categories. First, let’s clarify which one you belong to?
China divides medical beauty devices into three categories, with higher risks leading to stricter certification:
- Class I equipment (low-risk, accounting for 20%)
Example: Medical cold compress patch, beauty introduction device (without electricity)
The process is the simplest: just do “filing”, provide product technical documents and testing reports, the cycle is 3-6 months, and the cost is 50000 to 100000 Thai baht. - Class II devices (medium risk, accounting for 60%)
Example: Photon skin rejuvenation device, radiofrequency beauty device, hyaluronic acid injector
Registration approval is required: type testing (electromagnetic compatibility, safety performance testing) and clinical evaluation (collection of Chinese user usage data) must be conducted, with a cycle of 6-12 months and a cost of 200000 to 500000 Thai baht. - Class III devices (high-risk, accounting for 20%)
Example: Laser hair removal device, buried needle, medical endoscope
The strictest process: In addition to testing and clinical trials, clinical trials (with data from at least 200 Chinese patients) must also be conducted, with a cycle of 12-18 months and a cost starting at 1 million Thai baht.
3、 The authentication process is divided into 5 steps, which even beginners can understand
Step 1: Product classification prediction, don’t choose the wrong track
Find a professional agent to do “classification judgment” (we provide free pre evaluation), for example, the “radiofrequency beauty device” produced in Thailand belongs to Class II equipment, don’t apply for it according to Class I, it will waste time;
Confirm whether there are “same type of medical devices” in China, and if so, clinical data can be “borrowed” to save 50% of costs (such as referring to certified Korean similar equipment data).
Step 2: Prepare three core materials, none of which are indispensable
Technical document: Clearly state the product principle, structure, and manufacturing process in Chinese (such as “laser wavelength 810nm, hair removal achieved through semiconductor technology”). Thai engineers do not understand Chinese? We help with translation and polishing;
Test report: Send samples to a recognized laboratory in China (such as Beijing Medical Device Testing Center) for testing of electromagnetic radiation, safety, and other items, with a cycle of 2-3 months;
Clinical data: Class II devices must collect usage cases from Chinese hospitals (at least 3 hospitals, 50 cases data), and Class III devices must undergo strict clinical trials (we have resources from cooperating tertiary hospitals).
Step 3: Online application+offline review, follow the system
Submit materials through the “Medical Device Registration Management Information System” and wait for NMPA technical review (40-60 working days);
Failed to pass the review? Common problems include “technical parameter writing errors” and “incomplete clinical data”. We will help you analyze and correct them to avoid multiple rejections (there have been cases where a customer’s own application was rejected three times and was rejected after contacting us).
Step 4: Factory audit (only for Class II and III instruments)
NMPA will send experts to inspect the quality management system (GMP) of the Thai factory, with a focus on:
Is the production workshop divided into zones (clean area, sterile area);
Is the quality inspection record complete (such as the factory inspection report for each device);
We will conduct a ‘simulated audit’ for you in advance, rectify the factory process, and ensure a one-time pass.
Step 5: Obtaining certification and listing, compliant sales
After obtaining the registration certificate, it is necessary to find a “Medical Device Business License” agent in China to be responsible for sales and after-sales service;
The packaging and instructions must be in Chinese and consistent with the registered content (such as not allowing unauthorized modification of laser power parameters).
4、 Must see for Thai businesses: Don’t step on these 4 pitfalls!
- Do not touch royal elements
Packaging and promotion must not feature any Thai royal family related designs (such as royal badges or portraits of members). Although there is no legal prohibition in China, commercial use is strictly prohibited by Thai law. Some manufacturers have been sued locally in Thailand for this, and certification has also been implicated. - Serious consequences of data fraud
A Thai laser equipment factory falsified clinical data to save costs, which was discovered by NMPA. Not only was the certificate revoked, but it was also included in the “dishonesty list” and cannot apply for certification for 10 years, which is not worth the loss! - Trademark registration before authentication
Before certification, check the trademark on the China Trademark Network (such as whether “Taimei Laser” has been registered). We have helped our clients recover the core trademark that was preemptively registered to avoid being forced to change its name after certification. - Don’t wait for urgent promotion to start certification
The first three months of the Chinese medical beauty market promotion (Double 11, 38th Festival) are the peak period for certification. It is recommended to plan one year in advance, such as starting testing in September 2024 if you want to participate in Double 11 in 2025. Don’t rush around with the timing.
Summary: Once the certification is done, you can freely enter the Chinese market!
Medical beauty equipment entering China, certification is the ‘most difficult but worthwhile investment’. Don’t be intimidated by complex processes, finding the right agent can help you avoid 90% of the detours. Contact us now for a detailed list of materials, process schedule, and frequently asked questions to help you quickly obtain the “entry ticket” to the Chinese market