The "Laser Hair Growth Device" page found by the reporter on an online marketing platform
"Bald" Tathagata、Defending the hairline is something that many white-collar workers care about，All kinds of laser hair growth products are widely spread through Moments or e-commerce channels。But what consumers don’t know is， The imported "Gao Da Shang" laser hair growth products may be illegally sold medical devices。Our reporter's investigation found，Although some companies have、Penalized for operating medical devices without a medical device registration certificate，But the penalized products are still sold on e-commerce platforms。Insiders told reporters，At present, only a few companies’ laser hair growth products are registered or filed with the State Food and Drug Administration of my country。Unqualified laser hair growth products sold illegally may cause irreversible damage to hair follicles，There is a great safety hazard to consumers。
Citizen：Online hair loss treatment products let people "check"
As work pressure increases，Hair loss,There are even more and more bald white-collar workers。Ms. Li, who lives in Tianheyuan Village, is worried about the "bald" Tathagata，She told reporters，When showering and washing your hair every day，Hair fall，The hairline keeps moving up，Make people nervous。
This phenomenon is not uncommon，The reporter learned，White-collar workers who work night shifts or work a lot of overtime may face similar troubles。The results of a "Hair Loss Population Survey" published by the China Health Promotion and Education Association showed，About 250 million people with hair loss in China，Among them, the number of male hair loss is 160 million，Mainly between 20 and 40 years old，30Fastest development around the age of，The age of hair loss is 20 years earlier than the previous generation。and，The number of hair loss is still increasing every year。
According to data released by the national health department，China's hair health industry will grow at an annual rate of 260% in the next 10 years，Consumer spending on personal head care is rapidly increasing at a rate of 30% per year。
Today, it can be associated with "Internet +" in any industry，More and more consumers are buying medical devices online。On Taobao，The reporter entered the 4 words "laser growth"，18 pages of products can be found；At Jingdong Mall，The reporter entered the 4 words "laser growth"，5 pages of products can be found，The most sold reviews exceed 1,800。
Laser hair growth products are medical devices
However, a fact behind the product's hot sales may be ignored by white-collar workers。In order to ensure the safety of medical devices sold online，2018From March 1，State Food and Drug Administration(CFDA)Issued "Measures for the Supervision and Administration of Online Sales of Medical Devices" formally implemented。"Methods" pointed out：Enterprises engaged in online sales of medical devices should obtain medical device production licenses in accordance with the law、Medical device production and operation enterprise with business license or filing。Products sold need to display the product's medical device registration certificate or filing certificate on the product introduction page，Enterprises that enter online transactions for illegal operations and sales will be directly punished by the regulatory authorities。
Then，Do laser hair growth products belong to medical devices? Yes it is!The "Regulations on the Supervision and Administration of Medical Devices" define medical devices as：Instruments used directly or indirectly on the human body、equipment、Equipment、In vitro diagnostic reagents and calibrators、Materials and other similar or related items，Including the required computer software。
As long as the products are classified as medical devices，Whether it is domestic or imported，Are required to report to the State Food and Drug Administration(CFDA)Filing or registration，After obtaining CFDA approval，Was allowed to sell in the Chinese market。
The fined products are still sold on Internet platforms
2018November 7,，Shanghai Huangpu District Market Supervision and Administration Bureau issued an administrative penalty decision(Shanghai Supervision Yellow Office(2018)No. 012018000523)，According to regulations，Jebsen Consumer Goods Retail(Shanghai)The "HairMax Laser Hair Restoration Health Hair Belt 82 Red Light Anti-dropping Health Hair Helmet" sold in the official Jebsen flagship store operated by the company's Tmall platform is a second-class medical device.，But did not obtain a medical device registration certificate，The company is suspected of selling medical devices without a medical device registration certificate without filing。
Shanghai Huangpu District Market Supervision Administration fined him(418500yuan)、Confiscate illegal gains(3080.6yuan)Punishment。
The reporter learned，Many "home" health care or auxiliary treatment products，The attributes of its medical devices are often not emphasized in publicity，And for consumers，Without industry knowledge，Faced with products such as "hair growth instrument"，It is also difficult to distinguish whether it is a medical device，This resulted in the above fined products still being sold on the Internet。
On JD’s official flagship store of hairmax，The reporter noticed，The product named "HairMax Hair Growth Comb 82 beam laser hair healthy hair with red light hair loss prevention helmet beauty instrument Band82" is still on sale this year，The comment area shows that the most recent sales record was January 19, 2019，That is, after Shanghai’s penalty is issued，The product is still on sale。
328th of March，A public relations officer on Alibaba's Tmall platform told Guangzhou Daily all-media reporters，The platform has taken this product off the shelf，And supervise brands to conduct self-inspection and self-inspection of other products。
Tips
Beware： Unqualified laser hair growth products may damage hair follicles
Insiders told reporters，Currently approved by the State Food and Drug Administration(CFDA)Only 3 certified laser hair growth products：
American Abela soft laser hair growth helmet
Peninsula Electric Laser Hair Growth Device in China
Haerba Soft Laser Hair Growth Device from Korea
Unqualified laser hair growth products may cause irreversible damage to hair follicles，There is a great safety hazard to consumers。
Consumers should pay attention to buying and using medical devices
First of all，To verify the legality of the product，Medical device products should have "Medical Device Product Registration Certificate"(Or record certificate)、"Medical Device Production License"(Or record certificate)。You can log on to the official website of the State Drug Administration(http：//www.nmpa.gov.cn/)Check whether the product has registration information。
Secondly，To verify the qualification of the seller，The operation of the second category of medical devices requires medical device operation filing，The operation of the third category of medical devices requires a "medical device business license"。
(Note：The third category of medical devices is implanted into the human body，Used to sustain life，Its safety、Medical devices whose effectiveness must be strictly controlled。The second type of medical device refers to its safety、Medical devices whose effectiveness should be controlled。Medical laser equipment belongs to the second category of medical equipment。)
On the basis of verifying the qualifications of the product and the seller，Then choose to buy and use according to the doctor’s advice and your own situation，Choose your own，Rather than blindly follow suit。If you find that the products you buy and use are medical devices，But did not obtain the national medical device product registration certificate，Complaints and reports to the drug regulatory authority in time。
State Drug Administration reminded
It is illegal to produce or sell medical devices that have not obtained CFDA approval and certification。Medical devices that can be used for "home use" must also have a medical device product registration certificate。
When online dealers choose agent products，Preliminary judgments can be made from the product description and the "Medical Device Classification Catalogue" issued by the China Food and Drug Administration，You can also consult the Food and Drug Administration。If the product is found to be a medical device，Be sure to confirm whether the product has a medical device registration certificate，Whether the production or distribution company is qualified；And strictly abide by "Medical Device Online Sales Supervision and Administration Measures" and other relevant regulations，Go to the Food and Drug Administration for filing and business license procedures。
( Text/Reporter Liu Xingtu/Reporter Yang Yaoye)
