Questions and Answers about product naming
Q: Can the product name of medical electrical equipment add “portable, handheld” and other features
A. The general names of medical devices shall follow the Guiding Principles for Naming General Names of Medical Devices and the guiding principles for naming products of Classification Catalog. The GB 9706.1 standard has a clear definition of “handheld equipment, mobile equipment, portable equipment, mobile equipment”, but it does not mean that the definition of the standard can be added to the product name.
If it is a characteristic that a type of product usually has, it is generally not reflected in the general name of the product. For example, surgical electrodes must be handheld, so the feature word “handheld” will not be added to the product name. If a type of product usually has several different designs, corresponding feature words can be added to distinguish different design forms, such as: portable ultrasound diagnostic equipment, which is usually a product that can support long-term internal power supply and is easy to carry and move by hand, and is expected to switch between different usage scenarios (such as outpatient, ward, operating room, emergency, etc.) with the patient; The default feature word for ultrasound diagnostic equipment usually refers to a mobile product that is trolley like and does not involve changes in usage scenarios, but simply moves between different usage locations (from one consulting room to another).
Therefore, only when there is a significant difference between the product design and most of the cases of this type of product, and ambiguity may arise if not reflected as a feature word, will it be considered to indicate it in the product name. For example, ultrasound surgical equipment is usually composed of a host (desktop device), a transducer, and a knife head. If the product design integrates power supply, control components, transducers, and a knife head, which can be handheld and operated, it can be named “handheld ultrasound surgical equipment”.
Q. How to consider the batch and model in the detection limit and linearity study of in vitro diagnostic reagents?
A. The detection limit and linearity of in vitro diagnostic reagents are divided into detection limit establishment, detection limit verification, linear establishment, and linear verification. The samples used to establish and verify the detection limit should not be repeated, and the samples should cover all the claimed types or major types during the research process. The applicant shall submit all applicable model registration information, structure composition, instrument performance, reaction program setting parameters and reaction system comparison; The working principle, detection method, reaction condition control, signal processing and other aspects of the representative model and other models should be basically the same.
On the premise that the applicable model of the declared product has a representative model, the applicant can select a representative model to conduct three batches of product establishment research and one batch of product validation research; At the same time, use other models to carry out validation research on three batches of products. The applicant can also select all applicable models to conduct three batches of product establishment research and one batch of product validation research.The analytical performance of all applicable models should be basically the same. If there is a difference in the analytical performance of a test item between different models, different models should be used to establish and verify the analytical performance.
The above is the general requirements for conventional in vitro diagnostic reagents, for new products, new methods, special products or new problems in the performance evaluation, should be analyzed according to the specific situation of the application data.
Q. What are the special precautions for the blue light resistance of soft hydrophilic contact lenses?
A. The description of the anti- blue light performance in the registration application materials should not reflect the propaganda description such as “reducing radiation hazards”. It should refer to the product technical requirements and the relevant performance indicators in the research materials to describe as “blue light radiation reduction rate” and “ultraviolet radiation reduction rate”.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Article Source：CMDRA
Translated & edited ： Bradyknow
