Radiofrequency cosmetic medical device product registration information preparation and writing in the product specification, and labeling samples are also an important part of the product technical review of the declaration, in the technical review the opportunity to issue a supplement is also common, the following small list of radiofrequency cosmetic device specification, labeling sample requirements outline for you to share, more details and requirements of the filer can be based on the experience of the company’s technical R & D staff to improve and supplement, but also Welcome to discuss with the editor.
Product instructions and labeling samples should comply with the provisions of the “Medical Device Instructions and Labeling Regulations” and other applicable standards on the requirements of instructions and labels and should include details such as the use period, the date of revision or preparation of the instructions. If the product contains accessories with a limited number of uses, the number of uses of the reusable parts should be clear in the instructions and indicate the circumstances under which they can no longer be used. Single-use accessories should be clear shelf life.
Radiofrequency cosmetic equipment instructions should comply with the relevant requirements in the applicable safety standards. In addition, it should contain at least the following:
1. Clear indications, contraindications, and restrictions on the use of the product, clear for the population and applicable parts. Should give a schematic diagram of the parts that can be used and prohibited (such as the eyes, cheeks, neck, and other specific areas).
2. Clarify the use and applicable parts of each modality and therapeutic accessory, provide the results of energy safety studies conducted in the case, and give the necessary operating instructions and safety restrictions.
3. Clarify the relevant precautions for use, such as
(1) Metal accessories worn by the patient’s body should be removed prior to treatment.
(2) The treatment head should fit closely to the skin during the treatment operation, and some techniques require the use of standardized grid paper to avoid pulse superimposition.
(3) It is recommended to use lower energy and repeat multiple treatments to avoid the risk of heat accumulation in a single treatment site.
(4) The patient’s feedback on heat and pain sensation should be paid attention to at any time, and the output energy or treatment site should be adjusted at any time.
4. Clarify the use scenario and precautions about the use environment, and clarify the qualification, ability, and training of the equipment operator and other related requirements.
5. Equipment will work with the output of specific frequencies of electromagnetic energy, which should be based on the output form and energy intensity of the device, to give information about electromagnetic radiation and interference, as well as recommendations and precautions to avoid these interferences, including the installation and use of the instructions based on electromagnetic emission and electromagnetic immunity statement information.
6. Give information about the correct use of cooling, negative pressure, and other functions. If you need to use conductive gel or other supporting accessories, you should provide the appropriate way to use it.
7. For single-use treatment electrodes and related accessories, attention should be paid to whether the packaging is intact before use, and they should not be reused.
For handheld devices used in the home environment, special precautions should be given about the use environment and operation methods. The relevant information and instructions in the instruction manual should be easy to understand and use, and the results can be interpreted, and it is recommended to use more illustrations to explain. Precautions should also contain the following:
8. Description of the people who are not suitable for the use of the product (such as allergies, sensitive skin, etc.) and the application site (burns, blisters, wounds, infections, etc.). Patients with skin-related diseases should first consult a medical professional to determine whether the product can be used.
9. If abnormalities or discomfort occur after use, discontinue use immediately and seek medical treatment.
10. Give a complete description of the operation of the device and the operating procedure, as well as the common risks and related precautions for use in the intended environment.
11. Clearly give the verification method to determine whether the equipment is normal (including the use process and placement status), and the warning issued when the normal operation or failure is not explained.
12. Make clear the necessary preparations before use (e.g., skin cleaning, treatment, etc.), and make clear the use of other items to be used with (e.g., cosmetics, etc.).
13. Make it clear that the product should be placed out of the reach of children. Should avoid the use and placement near water sources or in the bathroom.
14. For internal power supply devices, it is clear that the designated charging device should be used to charge the device, and the battery status should be checked before use to see if it is normal.
With more than 100 service cases experience for medical equipment domestic and foreign medical device companies to provide medical device record information query: registrant R & D, commissioned production, product registration certificate, production license, by operating license, operating record certificate, a class of product record certificate, a class of product production license, inspection and testing, clinical trials CRO, GMP, ISO13485 quality management system The company also provides one-stop services such as production and operation licenses, software management, training on regulations and standards for three products and one weapon (food, drugs, cosmetics, medical devices), CE and FDA, etc.