In order to properly solve the common problems in the registration data of contact lens products after the implementation of the 2012 national standard of mandatory contact lens series, the evaluation scale is unified to ensure the safety and quality of the products under review. The medical device technical review center of the General Administration of the State Council organizes Representatives of some contact lens enterprises at home and abroad, and invited experts from Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration to hold a seminar on contact lens products in Beijing in May 2015. The meeting reached a consensus on the review issues related to the contact lens extraction test, and is now known to all relevant units for the reference of the relevant reporting units. See the attachment for details.

State Food and Drug Administration

Medical Device Technology Review Center

March 16, 2016

Attachment: Comments on issues related to the review of contact lens products

First, regarding the determination of the extraction rate and the solvent selection basis and verification data, the recommendations are as follows:

(1) Solvent selection

1. The solvent selection basis and verification data provided can indicate the applicability of the selected solvent. The organic solvent contains at least one solvent with strong extraction ability. If GB/T11417.7 "Ophthalmic optical contact lens Part 7: Physical and chemical properties test method If the solvent recommended in Table 2 of the standard is not applicable, the company shall provide evidence of non-applicability.

CMDE提出接触镜类产品审评中相关问题意见

(2) Selection of samples

1. The finished product is selected according to the requirements of the national standard and tested.

2. If the inspection lens is not all declared, it is advisable to evaluate the typicality of the sample to be inspected. For example, the color lens can be considered from the aspects of the type of dye and the total amount of the formula.

(3) Suggestions on the extraction rate limit of existing mature material lenses

According to the 2012 version of GB11417.2 "Ophthalmic optical contact lens Part 2: Hard contact lens" (hereinafter referred to as the 2012 version of the rigid contact lens), GB11417.3 "Ophthalmic optical contact lens Part 3: Soft contact lens" in the extraction laboratory Note requirements (can be selected according to hard or soft mirror). For the extraction rate limit of existing mature material lenses, it is recommended to consider one of the following methods. If there are other methods that are more suitable for confirming the extraction rate limit of the declared product, please elaborate. Replace the reasons for the following methods and provide the corresponding verification data:

1. The total extraction rate limit can be determined by the material evaluated by the company through biological evaluation, that is, the total extraction rate of each solvent formulated in the technical requirements of the product should not be higher than the actual extraction rate of each solvent of the material that has passed the whole biological evaluation. The material should in principle be identical to the main production process of the declared product and have the same formulation.

2. The toxicological data of each component of the lens material can also be collected according to the principle of GB/T16886.17 "Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachables", for toxicology that cannot be collected/not obtained. The components of the data can be evaluated according to the risk analysis, and the total limit of the lens extraction rate is finally determined. Note that calculation procedures and references involving specific values ​​should be provided.

(4) Method for determining the extraction rate limit of new material lenses

Quantitative and qualitative analysis of extractables should be carried out by appropriate chromatographic, spectrophotometric, and wet analysis to determine the amount of residual monomer, crosslinker, and initiator during the polymerization process. The basis for providing a limit for each component of the lens material can be determined by toxicological data for each substance.

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