What is within the scope of Class I medical device registration

Hunan Pharmaceutical Group specializes in providing integrated services for the transformation, registration, production, and R&D of medical devices, with 15367859988 services. According to the Regulations on the Supervision and Administration of Medical Devices, the registration of Class III medical devices needs to meet the following conditions:

1.Have a legal business license and organization certificate, and provide true and complete enterprise information and product information when registering. 2.

The products applying for registration must comply with national medical device standards or industry standards, and have undergone standardized review and filing. 3.The product applying for registration must be through clinical trials or clinically validated, and supported by appropriate clinical data.

4.Products applying for registration must be registered and tested, and a qualified test report must be submitted. 5.

The products applying for registration must comply with the relevant national safety requirements

Knives, scissors, forceps, bandages, instrument bags, etc., are some products that are not very harmful, and the Food and Drug Administration can inquire about them, but sometimes the classification of Class I and Class II products will be adjusted, and we should pay attention to the notice of the Food and Drug Administration.

The pressure less than 4 kg is the first category, greater than 4 is between the 6 is the second category, and greater than 6 is the third category, calculated according to the pressure!

Lianyungang Youyuan Pharmaceutical Equipment Manufacturing **** Sales Department.

There is a medical device classification list, and the above is very clear. If your medical device wants to be innovative, it should be reported according to three categories in China.

The first type is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness. Class I medical devices refer to medical devices that have been routinely managed. Under normal circumstances, all in vitro applications do not have direct contact with ** or tissue, the structure is relatively simple, the function is relatively simple, generally passive (external or built-in power supply or other power sources), there is a certain auxiliary or alleviating symptoms or prevention effect, the potential risk is very little or almost no risk, without special management can ensure that its medical devices are mostly a class of medical devices.

Basic Surgical InstrumentsMicrosurgical Instruments.

Neurosurgical instruments, ophthalmic surgical instruments.

Otolaryngology Surgical InstrumentsOral Surgical Instruments.

Thoracic cardiovascular surgical instruments, abdominal surgical instruments.

Urorectal Surgical Instruments, Orthopedic (Orthopedic) Surgical Instruments.

Surgical instruments for obstetrics and gynecology and family planning surgical instruments.

Injection and puncture instruments, surgical instruments for burn (plastic) surgery.

General diagnostic equipment, medical electronic instruments and equipment.

Medical optical instruments, instruments and endoscopic equipmentMedical ultrasound instruments and related equipment.

Medical laser instruments and equipment, medical high-frequency instruments and equipment.

Physics**and**equipmentTraditional Chinese medicine equipment.

Medical magnetic resonance equipment, medical X-ray equipment.

Medical X-ray Accessories and ComponentsMedical High Energy Ray Equipment.

Medical nuclide equipment, medical radiation protection equipment, devices.

Clinical laboratory analysis instruments, medical laboratory tests and basic equipment and appliances.

Cardiopulmonary bypass and blood processing equipment, implanted materials and artificial organs.

Operating room, emergency room, diagnosis and treatment room equipment and equipment, dental equipment and appliances.

Ward nursing equipment and utensils, disinfection and sterilization equipment and appliances.

Medical cold therapy, low temperature, refrigeration equipment and appliances dental materials.

Medical hygiene materials and dressings, medical suture materials and adhesives.

Medical polymer materials and products interventional equipment.

The first class of medical devices is a medical device with a low degree of risk and routine management that can ensure its safety and effectiveness, such as scalpels, surgical scissors, manual hospital beds, medical ice packs, cooling stickers, etc., and its products and production activities are subject to record management by the food and drug regulatory department of the city divided into districts. Business activities are all liberalized, and there is no need for a license or a record, and only a business license issued by the industrial and commercial department is required.

Medical devices have three types of registration certificates, and cannot operate Class II vertical sliding pins, Class I products can be operated, and Class I products do not need to be licensed and filed when they are operated.

According to Article 4 of the Measures for the Supervision and Administration of Medical Device Operation, according to the risk degree of medical devices, the operation of medical after-medical recreation equipment shall be classified and managed. The operation of Class I medical devices does not require licensing and filing, the operation of Class II medical devices is subject to record management, and the operation of Class III medical devices is subject to license management.

This article mainly introduces how to check the medical device to be newly registered through the official website of the Food and Drug Administration.

Tools Raw materials

Browser. Method stepsClick "Medical Devices" - "Medical Device Query" in the navigation bar to enter the data query system.

Hezhou In the medical device column, click on "Medical Device Classification Catalog".

Find the corresponding product name and click on it to view the details and know the corresponding management category, i.e. the class of medical devices it belongs to.

Precautions

When we apply for a medical device registration certificate for a medical device to be marketed and used, we first need to distinguish which class of medical devices the new product to apply for belongs to before we can further handle the follow-up matters.

If the newly registered medical device cannot find the same or similar product name in the classification catalog, it can directly apply for product registration in accordance with the provisions of the third class medical device product registration, or you can judge the product category according to the classification rules and apply for category confirmation to the food and drug supervision and administration department.