PHDS HEALTHCARE RESEARCH Co., Ltd.
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Product Registration
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Medical device registration
Service Overview
Our medical device registration service is designed for manufacturers, aiming to ensure that your products smoothly pass the review and approval process of the National Medical Products Administration (NMPA) through professional technical support and compliance services.Our goal is to provide comprehensive registration solutions for your medical device products, from initial preparation to final market access, ensuring product safety and effectiveness, and protecting public health.
Service Content
Product Classification and Registration Strategy
Product Classification Positioning:Provide accurate classification positioning for your products based on the risk level of medical devices.
Registration Path Planning:Develop corresponding registration strategies and paths for different categories of medical devices.
Comprehensive Registration Document Preparation
Technical Document Preparation:Including product manuals, labels, production process flowcharts, quality management system documents, etc., detailing the structure, performance, and quality control measures of the product.
Performance Data Organization:Organize product testing reports and clinical trial reports to ensure that product performance indicators meet relevant standards and requirements.
Registration Application and Pre-review
Online Application Submission:Submit registration applications through the online platform designated by NMPA and conduct preliminary pre-review.
Document Format and Content Review:Ensure that the format and content of the application materials meet NMPA's requirements.
Technical Review and On-site Audit
In-depth Technical Review:Organize professionals to conduct technical reviews of application materials, focusing on reviewing information related to the technical performance, safety, and effectiveness of medical devices.
On-site Audit Coordination:For high-risk medical devices that require on-site audits, coordinate with NMPA for on-site audits to ensure that the production process and quality management system meet requirements.
Clinical Trial Review and Support
Clinical Trial Protocol Evaluation:Provide scientific and reasonable evaluations of clinical trial protocols for medical devices that require clinical trials.
Clinical Trial Result Analysis:Analyze the authenticity, reliability, and effectiveness of clinical trial results to ensure that data supports the product's registration application.
Review Decision and Issuance of Registration Certificate
Review Result Response:Provide professional response strategies based on NMPA's review decisions, including obtaining the registration certificate after approval and guidance for subsequent work.
Registration Certificate Management:Assist in managing registration certificates, including regularly submitting annual reports, applying for changes, renewal applications, etc., to ensure that product quality and safety meet requirements throughout its lifecycle.
Our Capabilities
| Professional Knowledge:Our team consists of experts in cosmetic regulations and industry consultants who have an in-depth understanding of cosmetic registration processes and regulatory requirements. | Efficient Processes:We have optimized the registration process to quickly respond to and handle various registration matters, shortening your product's time to market. |
| Successful Cases:We have numerous successful cases helping clients smoothly pass through the registration process and obtain cosmetic approval certificates. | Customer Service:We provide one-on-one customer service to ensure that every question you have can be answered promptly and professionally. |
Why Choose Us
One-stop Service:From consultation to registration, we provide one-stop services so you don't have to worry about complicated registration processes.
Professional Team:Our team members have a solid industry background and professional knowledge to provide you with precise consulting services.
Cost-effectiveness:Through our professional services, you can avoid time and cost losses caused by insufficient document preparation or unfamiliarity with processes.
Continuous Support:We not only help you complete registration but also provide ongoing supervision and management services to ensure your products remain compliant.
'By choosing us, you will gain a trusted partner who helps your cosmetic business enter the market smoothly and efficiently. We look forward to working with you to create a beautiful future.'
'Medical Device Registration'
'Medical device registration is a complex and time-consuming process that requires manufacturers to invest significant resources and effort. To simplify this process, many manufacturers choose to collaborate with professional medical device registration consulting companies. For example, international CROs like Bo Shi Zhi Xing can provide comprehensive technical and compliance services including preparing registration documents, submitting applications, coordinating communication with regulatory authorities, etc., helping manufacturers complete the registration process more efficiently.'
Registration Classification
Class I Medical Device Registration:
Class I medical devices are low-risk devices subject to filing management. Enterprises need to submit filing forms, product technical requirements, product inspection reports, etc., for filing with district-level drug supervision departments. They can only produce or sell after obtaining filing certificates.Class II Medical Device Registration:
Class II medical devices have moderate risk levels requiring registration approval. Enterprises must submit registration application materials including product technical requirements, product inspection reports, clinical evaluation materials, etc., to provincial drug supervision departments. After passing review, they will obtain a medical device registration certificate.二类医疗器械具有中度风险，需要进行注册审批。企业需向省级药品监督管理部门提交注册申请资料，包括产品技术要求、产品检验报告、临床评价资料等，经审核通过后获得医疗器械注册证
Class III medical device registration:Class III medical devices have a higher risk level, and their registration applications must be submitted directly to the National Medical Products Administration (NMPA). In addition to the aforementioned product technical requirements, inspection reports, and clinical evaluation materials, more detailed clinical trial data and risk analysis reports must also be provided. After approval, a Class III medical device registration certificate will be obtained.
CRO registration preparation and process
Preparation of application materials:
- Technical documents: including product manuals, labels, production process flow charts, quality management system documents, etc., detailing the product's structure, performance, usage methods, production processes, and quality control measures.
- Performance data: such as product testing reports, which must be issued by qualified testing institutions to prove that the product's performance indicators meet relevant standards and requirements; for some Class III medical devices, clinical trial reports must also be provided to verify
the safety and effectiveness of the product.
- Design specifications: including product structure diagrams, dimensions, materials, etc., which help regulatory authorities fully understand the design characteristics of the product.
- Accepting entrusted registration agents (if applicable): Foreign manufacturers usually need to entrust a registration agent established in China. The registration agent must be authorized by NMPA to represent the applicant in the registration application and communication with NMPA.
- Online application and pre-review: Submit the registration application through the online platform designated by NMPA and conduct a preliminary review. NMPA will conduct a preliminary examination of the format and content of the application materials to confirm whether they are complete and meet requirements.
- Technical review: NMPA organizes professionals to conduct an in-depth technical review of the application materials, focusing on reviewing information related to the technical performance, safety, effectiveness of medical devices, etc., to ensure that products comply with relevant regulations and standards.
- On-site audit (if necessary): For high-risk medical devices or situations deemed necessary by regulatory authorities, NMPA will conduct on-site audits to inspect the production process and quality management system of medical devices, including checks on production sites, production equipment, personnel operations, quality control measures, etc., to ensure that product quality and safety are effectively guaranteed.
- Clinical trial review (if applicable): If the applied medical device requires clinical trials, NMPA will strictly review the clinical trial protocol and report, assessing the scientificity, rationality, and feasibility of the clinical trial protocol as well as analyzing the authenticity, reliability, and effectiveness of clinical trial results to ensure that clinical trial data can support the product's registration application.
- Review decision: After comprehensive review and audit, NMPA will make a review decision to approve or reject the medical device's registration application. If approved, NMPA will issue a medical device registration certificate; if rejected, enterprises can improve or adjust based on the review decision and resubmit their application.
- Issuance of registration certificate and follow-up work: After obtaining the registration certificate, enterprises must comply with relevant regulations and provisions of NMPA, such as regularly submitting annual reports, applying for changes or renewals, etc., to ensure that product quality and safety meet requirements throughout its lifecycle.
Registration process that producers need to understand and cooperate with:
Product Classification Positioning:First, manufacturers need to determine the classification of their products. Medical devices are generally divided into three categories based on their risk levels. Class I products have lower risks while Class III products have higher risks.
Preparation of registration materials:Manufacturers need to prepare a series of materials including product technical requirements, product manuals, product testing reports, clinical evaluation materials, etc. These materials need to detail the design, manufacturing process, intended use as well as relevant safety and effectiveness data of the product.
Submission of registration application:Manufacturers submit prepared registration materials to NMPA. The submitted materials must comply with relevant regulations and standard requirements.
Technical review:The technical review department of NMPA will conduct a detailed examination of the submitted materials to assess the safety and effectiveness of the product. This process may include evaluations of product design, manufacturing processes, clinical data, etc.
On-site inspection and audit:For certain high-risk products, NMPA may arrange on-site inspections to verify whether the production processes and quality control measures meet requirements.
Registration approval and certificate issuance:If the product's registration application passes all reviews and assessments, NMPA will issue a medical device registration certificate allowing the product to be sold and used in the market.
Post-market supervision:Even if a product has obtained a registration certificate, manufacturers still need to continuously monitor and evaluate their products to ensure long-term safety and effectiveness. Manufacturers are required to regularly submit usage reports and related adverse event reports to NMPA.
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Contact Information
Customer service hotline:
E-mail:customer@cnphds.com
Address: Building A, Ocean Express,66 Xia Guang Li, Dong San Huan North Road,Chaoyang district, Beijing, China
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