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Guidelines for review of registration of metallic bone pins

Guidelines for review of registration of metallic bone pins

  • Categories:Industry dynamic
  • Author:
  • Origin:
  • Time of issue:2025-05-22
  • Views:260

(Summary description)

Guidelines for review of registration of metallic bone pins

(Summary description)

  • Categories:Industry dynamic
  • Author:
  • Origin:
  • Time of issue:2025-05-22
  • Views:260
Information

The purpose of this guideline is to guide the registration applicant to prepare and write the registration data of metallic bone pins, and also to provide reference for the technical review department to review the registration data.

This guideline is a general requirement for the registration of metallic bone pins, the applicant should determine whether the content is applicable according to the specific characteristics of the product. If not applicable, need to specify the reasons and the corresponding scientific basis, and based on the specific characteristics of the product to enrich and refine the content of the registration information.

This guideline is for registration applicants and technical reviewers to use the guiding documents, but does not include the administrative matters involved in registration and approval, not as a mandatory implementation of regulations, need to follow the relevant laws and regulations and the current effective national standards or industry standards under the premise of the use of this guideline. If there are other methods that can meet the requirements of the relevant regulations, they can also be used, but need to provide detailed research information and verification information.

This guideline is formulated under the current regulations and standards system and the current level of knowledge, with the continuous updating and improvement of regulations and standards, as well as the continuous development of science and technology, the relevant content will be adjusted in due course.

I. Scope of application

This guideline applies to partially implanted in the human body for traction when limb fracture reduction, with external fixation bracket for limb fracture fixation or implanted separately for internal fixation of limb fracture metal bone pin products. These products include Kirschner's pins and Schnitzer's pins, which are generally made of stainless steel, titanium alloy materials, forged cobalt-chromium-tungsten-nickel materials through conventional mechanical processing, heat treatment and surface treatment processes.

This guideline does not apply to metal bone needle products with special structural design, using new materials, new technology, but the applicable part can be based on the product's specific design principles, structural features, biomechanical properties and clinical requirements, reference to the relevant content of this guideline.

Second, the registration review points

Registration information should be consistent with the State Drug Administration “on the publication of medical device registration information requirements and approval of the announcement of the format of the supporting documents” in the requirements, it is appropriate to meet the following requirements at the same time:

(A) regulatory information

1. Product name

Product naming needs to use national standards, industry standards in the common name, or the product structure and composition, clinical intended use, applicable parts of the name based on the need to comply with the “Naming Rules for General Names of Medical Devices” “Passive Implantable Devices General Name Naming Guidelines,” and other relevant regulations, can be increased to express the product material, special design and other characteristics of the word, such as metal bone needle, stainless steel metal bone needle, Hydroxyapatite coated metal bone needle, etc..

2.Classification Code

According to “Medical Device Classification Catalog”, the classification code is 13-01-06, and the management category is Class III.

3.Classification of registration unit

The division of the product registration unit should be in line with the requirements of the “Guiding Principles for the Division of Medical Device Registration Unit”.

Different materials need to be divided into different registration units. Coated and uncoated products should be divided into different registration units, different coating materials of metal bone needles should be declared as different registration units.

(B) the synthesis of information

1. Product description

1.1 clear structure and composition of the product, including but not limited to the selection of materials and standards, material grade information, coating information, delivery status, sterilization, sterilization information.

1.2 Specify the common name of the product and its basis for determining; specify the management category of the product, including: the name of the sub-category, the first product category, the second product category, management category, classification code; specify the scope of application of the product; specify the product's background information summary or special details, such as: a summary of the history of the declared product, the situation of domestic and foreign marketing, the overview of the predecessor product (if any), the previous registrations declaration situation, relationship with other approved marketed products, etc. If not applicable, it should be stated.

1.3 The description of product structural design generally includes the specifications of each model of the product, the structural drawings of each key part and the geometric dimensions (including tolerances).

Structural drawings should be clear from the overall appearance, local details of the magnification of the product design features, if necessary, should be submitted to the clinical use of anatomical adaptations. Define the thread design, with coated products coating distribution.

Geometric parameters mainly include the length and diameter of the body, the length of the coated position (if applicable), and the thread size (if applicable).

For coated metal bone needles, it is recommended to refer to YY/T 0988.14 “Test Method for Stereological Evaluation of Porous Coatings Used in Surgical Implants” to clarify the coating thickness, porosity, average intercept and other coating characterization parameters.

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