Medical Device Industry, Another Subdivision Area Reshuffle Comes

Medicine Network May 28 hearing medical device industry, another subdivision area reshuffle arrived.

May 25th, Country drug The website of the Supervision Administration issued the “Notification on the Classification and Definition of Intense Pulsed Light Hair Removal Products” (Pharmaceutics Supervision Office [2018] No. 10), which classifies intense pulsed light hair removal products as Class II. medical instruments Management, classification code 09-03-3.

At the same time, the “Notice” gives the range of products for strong pulsed light hair removal products from product composition, efficacy principle and use:

The intense pulsed light epilation products involved usually consist of light source, control device, flash window, flash emission button, indicator/screen, power adapter and so on. By generating strong pulse light to irradiate the skin, the temperature of the hair follicle and the surrounding tissue increases. And structural changes occur, which inhibit hair growth or shrink hair off. This type of product is a portable handheld device that can be used by individuals according to the instructions.

The notification also requires that, starting from the date of the notification, it may apply for registration in accordance with the "Measures for the Administration of Registration of Medical Devices" (Order No. 4 of the State Food and Drug Administration). Since January 1, 2023, intense pulse light has been removed Products that fail to obtain a medical device registration certificate according to law may not be produced, imported, or sold.

It can be seen that products with strong pulsed light hair removal products, such as IPL hair removal instruments, must be formally classified as Class II medical devices. It is clear that the industry is strictly regulated through the improvement of access barriers. In the process, the first ones are related to medicine. US industry-related medical device production, operation enterprise , And medical beauty agencies will also be affected.

First of all, for manufacturers of strong pulsed light hair removal products, the production threshold is raised, not only to obtain such product registration certificate, but also to obtain a production license. It takes money and time.

The newly revised "Medical Device Supervision and Management Regulations" that came into force on June 1, 2014 shows that enterprises engaged in the production of Type II medical devices should apply for production licenses from the food and drug regulatory departments of the provinces, autonomous regions, and municipalities directly under the Central Government, and submit them. Qualified information and registration certificate of the medical device produced.

In addition, the "Regulations on the Supervision and Administration of Medical Devices" also requires that the second-tier production enterprises conduct inspections in accordance with the requirements of the quality management specifications for medical devices produced by the State Council's food and drug administration department. Those who do not meet the prescribed conditions are not permitted.

Two thresholds, there will be some small and medium-sized companies out of the game, but also enhance the industry concentration in this segment.

For the operating companies that operate strong pulsed light hair removal products, there is an additional checkpoint for the record, and the restrictions imposed through Internet sales have tightened.

The "Regulations on the Supervision and Management of Medical Devices" stipulates that, when engaged in the second type of medical device operations, the operating enterprise shall record with the municipal food and drug administration department of the locality where it is located and submit relevant certification materials. At the same time, in the business premises, storage conditions, quality management Staff also have restrictions.

The Saibo Blue device learned that, at present, for products such as IPL hair removal instruments, in addition to the offline business enterprises, there are abounding third-party network platforms such as Tmall, Jingdong, Taobao and others that operate the product. Search for 'IPL' In the product list given by the hair removal apparatus, there are many brands, and the price of a single product ranges from a few hundred dollars to several thousand dollars. Although there are some well-known brands such as Philips, Braun, etc., but do not rule out some unknown brands. Recharge. After all, the network third-party platform 'you understand'.

It is understood that the implementation of the Measures for the Supervision and Administration of Medical Device Network Sales from March 1, 2018 has clarified the principle of “online, offline, and consistent”. Enterprises that engage in the sale of medical device networks should apply for obtaining medical device production licenses according to law. , The business license or the entity that handles the filing for the production of medical equipment can sell the medical equipment on its own website or through a third-party platform for medical device network trading services.

For those who are not registered to engage in the sale of the second type of medical equipment on the network, they will be punished accordingly.

It can be seen that after the strong pulsed light hair removal products are defined as second-class medical devices, some companies that have used such products will be knocked out.

Another is the use of links.

Since the IPL hair removal apparatus can be used both for home and medical purposes, the safety of use has been improved for individual consumers after the specification of the production and operation end. hospital The use of dermatology is less than that of medical and beauty institutions, and the latter will be regulated strictly.

The "Applied Medical Device Quality Supervision and Management Measures" implemented on February 1, 2016, for the use of medical devices, from purchase , Storage, maintenance, etc. have strict regulations.

For example, it is necessary to purchase medical devices from qualified medical device manufacturing enterprises, request, verify supplier qualifications, medical device registration certificates, or record vouchers, etc.; use non-qualifying documents, expired, expired, expired medical devices , Or the use of unregistered medical devices will be severely punished.

In fact, intense pulsed light hair removal products are mainly aimed at the medical and pharmaceutical industry. When the restrictions on the product increase, it may be an additional measure for the supervision of the medical industry.

It should be pointed out that on April 26 of this year, the New State Food and Drug Administration 'burned out' the 'head fire' to rectify the operation and use of medical devices, and decided to carry out a special rectification operation nationwide from May to November this year. One of the remediation tasks is to strictly investigate the actions of high-injection sodium hyaluronate and other products with high concern for illegal business.

In the end, after defining strong pulsed light hair removal products as the second type of medical devices, joints such as production, operation, and use are strictly regulated for the subdivided areas of such products.