TX Q&A

In theory, the temperature for real-time stability studies of products should generally be the same as the storage temperature. If there are specific regulations, these should be followed first, such as in GB/T 11417.8-2012 "Ophthalmic optics - Contact lenses - Part 8: Determination of shelf-life," which specifically sets the stability study temperature for corneal contact lens products at 25±2°C. For medical devices that are required to be stored at room temperature and have no special regulations, the temperature for real-time stability validation is not strictly enforced to be at 25°C±2°C. Documentation should be provided based on the characteristics of the product. For medical devices that require a specific storage temperature, validation studies should be conducted at that specified temperature.

For most medical devices (non-in vitro diagnostic reagents), the stability and shelf life generally depend on the raw materials used and aging mechanisms, such as thermal aging and photoaging. If the performance of raw materials, manufacturing processes, and packaging materials remains stable, different batches should not affect the product's stability and efficacy in principle. Therefore, whether it is necessary to submit research data on stability or packaging validation for different batches should be considered in conjunction with the product's characteristics and technical requirements. If the product has special properties, such as containing bioactive substances, submitting research data for different batches may be considered. In other cases, it is not mandatory in principle.

When an applicant applies for the separate registration of a liner product, they need to provide relevant information about the outer cup intended for use with it, including materials, structural design, and model specifications, as well as related research and testing data on compatibility performance, such as press-out tests, rotational stability tests, and lever-out tests, along with relevant discussions. If there is no already registered matching outer cup, it can be declared together with the matching outer cup product or declared separately.

The regulation specifies that if the registration certificate and its annexes for the already registered products remain unchanged and comply with the new mandatory standards, re-registration is unnecessary. This includes two cases: 1. The declared product has applicable mandatory standards. The technical requirements of the product cite the mandatory standards either by "directly quoting the specific content of the mandatory standard clauses," "standard number," or "standard number + year code." When the mandatory standard is updated, and the standard number and/or year code changes, but the content of the mandatory standard clauses cited in the product's technical requirements remains unchanged. 2. The declared product does not have applicable mandatory standards. The technical requirements of the product refer to the clauses of a certain mandatory standard. When the mandatory standard is updated, and the standard number and/or year code changes, the content of the mandatory standard clauses referred to in the product's technical requirements remains unchanged; or the content of the referred clauses changes, but the product's technical requirements still refer to the clauses of the previous version of the standard. In the above situations, if the product's technical requirements remain unchanged or only the referenced standard number and/or year code are updated, there is no need to undergo re-registration. This procedure also applies to the management of in vitro diagnostic reagents involving updates and replacements of national standards.

If the medical device registration certificate is nearing expiration and needs to be renewed, the registrant must apply for renewal registration six months before the expiration of the certificate and submit the required application materials accordingly. If the application materials are incomplete or do not meet the legal format, requiring correction, CMDE will indicate the registrant's initial application date for renewal registration in the acceptance notification for correction. When the registrant reapplies for renewal registration after making corrections, they must submit the acceptance notification for correction. CMDE will determine whether the application for renewal registration was made six months before the expiration of the medical device registration certificate based on the initial application date for renewal registration indicated in the acceptance notification for correction and will review the application materials in accordance with the regulations.

Interference tests are generally conducted using a paired comparison method, comparing the results of samples containing high concentrations of interfering substances with those containing no or normal concentrations of interfering substances (control). For qualitative diagnostic reagents that can provide quantitative data (such as OD values, Ct values, etc.) or count results, it is recommended to perform a numerical difference analysis. It is not advisable to represent the results of interference tests solely by positive or negative outcomes.

In the clinical trials of in vitro diagnostic reagents, inclusion and exclusion criteria for subjects should be reasonably set based on the intended use and applicable population of the product. It is crucial that the clinical trial subjects come from the population intended for the product's use, such as individuals with specific symptoms, signs, physiological or pathological states, or certain epidemiological backgrounds. Enrolling subjects outside the target population may introduce selection bias, leading to clinical trial results that do not reflect the true performance of the product. For example, in vitro diagnostic reagents intended for the auxiliary diagnosis of a particular disease should not randomly include a large number of asymptomatic healthy subjects in clinical trials. Clinical trials for hepatitis B, hepatitis C, HIV, and syphilis antibody testing reagents should not include a large number of preoperative screening patients who do not exhibit relevant symptoms or signs. Such inclusion criteria could lead to a deviation in the clinical specificity evaluation of the product from its true performance.

No, they cannot. The coating is a crucial component of drug-eluting stents and significantly affects the product's safety and effectiveness. According to the "Guidance on the Division of Medical Device Registration Units" for non-active medical devices, medical devices containing drugs (active substances) and those not containing drugs (active substances) should be classified into different registration units.

Patient monitors typically include modules for ECG, body temperature, blood oxygen, non-invasive blood pressure, invasive blood pressure, respiration, EEG, anesthesia, etc., each with several accessories that come into contact with the human body, resulting in numerous accessories being declared. For easier review of the documentation, the following requirements are recommended: 1. Refer to the structure of the application form, classify by functional module, and list the names, contact parts, contact duration, nature of contact, method of biological evaluation (exemption, evaluation, testing), and corresponding evaluation documentation names and numbers for each accessory that contacts the body. 2. For biological testing, also specify the biological test items, basis for testing, test results, and test report numbers. 3. For tests conducted on representative accessories, the reasons for selecting typical models should be explained.

According to clause 3.5.1.2 of the mandatory industry standard YY 0053-2016, high-flux hemodialyzers should be evaluated for β2 microglobulin clearance rate at a clinically common blood flow rate, and it is permissible to choose a single blood flow rate for this evaluation.