Drugdu.com expert's response:

Key Processes for Medical Devices from R&D to Production

Medical devices must undergo several critical processes, including infrastructure establishment, quality management system (QMS) development, product design and development, registration testing, clinical evaluation, product registration application, on-site QMS verification, production license application, and market launch. The specifics are as follows:

Infrastructure Establishment

Business Registration: Determine the business scope based on corporate development plans and product positioning, then complete registration under the current registered capital subscription system and the "three-in-one" registration system (merging business licenses, organization code certificates, and tax registration certificates).

Hardware Preparation: Construct facilities compliant with the Medical Device Production Quality Management Standardsaccording to the category and process requirements of the intended medical devices. If the product requires a sterile environment, a qualified cleanroom must be built. Additionally, acquire production equipment and inspection instruments necessary for manufacturing and testing. If a company faces challenges in hardware investment or seeks to expedite the process, it may opt for the registered person system, entrusting production to a qualified and established medical device manufacturer to reduce initial capital expenditure and time costs.

Quality Management System Development

After the appointment of key personnel, including the corporate leader, management representative, quality manager, and R&D manager, establish a comprehensive QMS tailored to the manufactured products. This system should adhere to the Medical Device Production Quality Management Standards and the recommended standard GB/T42061-2022 (equivalent to ISO 13485). The QMS encompasses a quality manual, procedural documents (e.g., document control, design and development control, procurement control, risk management control, adverse event management control, recall management control), work instructions, and records. This process can be conducted concurrently with design and development, but attention must be paid to the logical sequence of events.

Product Design and Development

According to ISO 13485, the design and development of medical devices can be broadly divided into seven stages:

Project Planning Stage: Define project objectives, scope, resource requirements, timelines, and risk management plans.

Design Input Stage: Integrate regulatory requirements, incorporating national and industry standards, as well as registration requirements, into design specifications. Refine technical requirements, including functionality (e.g., precision, stability), safety (e.g., biocompatibility, sterility), and software compliance. Prioritize the operational habits and practical pain points of doctors and patients.

Design Output Stage: Translate design inputs into specific, achievable outcomes, including product drawings, technical specifications, bill of materials (BOM), preliminary product technical requirements, preliminary production processes, risk management reports, and preliminary packaging and labeling designs.

Design Verification Stage: Confirm through objective evidence (e.g., testing, calculations, comparative analysis) that design outputs meet design input requirements. This includes basic performance testing (e.g., electrical safety, mechanical strength, software stability) and specialized testing (e.g., environmental testing, EMC testing, aging testing).

Design Confirmation Stage: Validate through objective evidence (typically clinical evaluation data) that the final product meets user needs and intended uses under specified conditions. Clinical evaluation can be conducted through three pathways: exemption from clinical trials for products listed in the Catalog of Medical Devices Exempt from Clinical Trials; analysis and evaluation of clinical trial data or clinical use data from similar medical devices; or conducting clinical trials in accordance with the Good Clinical Practice for Medical Device Trials.

Design Transfer Stage: Ensure that design outputs can be accurately, consistently, and efficiently translated into repeatable mass production. Verify whether production processes, equipment, tooling, and inspection methods can stably produce products that meet design requirements.

Design Change Stage: Design changes may be necessary during or after the design and development process due to various reasons (e.g., input changes, issues identified during verification/confirmation, regulatory updates). Any changes must undergo review, verification/confirmation (if necessary), approval, and an assessment of their impact on product safety and effectiveness in accordance with specified procedures.

Registration Testing

After completing design and development and producing prototype samples, registration or备案 (filing) applications for medical devices must include testing conducted in accordance with product technical requirements, as stipulated by the Medical Device Registration and Filing Administration Measures. Only samples that pass testing can be used for clinical trials (if required) or as the basis for registration/filing applications. Testing samples should be representative and capable of demonstrating the safety and effectiveness of the registered or filed products, with their production adhering to the relevant requirements of the Medical Device Production Quality Management Standards. Registration testing is typically entrusted to qualified medical device testing institutions, with testing items determined based on product technical requirements and potentially covering safety performance, electromagnetic compatibility (EMC), and biocompatibility.

Product Registration Application

Upon completing R&D, testing, and clinical evaluation (if required), and preparing for QMS verification, proceed to the product registration application stage. This is a complex and systematic task requiring close collaboration and support from all relevant departments, including R&D, quality, production, and regulatory affairs. Submit applications to different regulatory authorities based on product category and origin:

Domestic Class I Medical Devices: Submit filing documents to the municipal drug regulatory authority responsible for medical device supervision.

Domestic Class II Medical Devices: Submit registration documents to the provincial, autonomous regional, or municipal drug regulatory authorities.

Domestic Class III Medical Devices: Submit registration documents to the National Medical Products Administration (NMPA).

Imported Class I Medical Devices: Submit filing documents to the NMPA.

Imported Class II and III Medical Devices: Submit registration documents to the NMPA.

On-Site QMS Verification

Applicants must submit QMS-related documents concerning product research, development, and production when applying for registration. If the accepting authority deems on-site verification necessary, it shall organize a QMS inspection. For domestic Class III medical devices, the NMPA's Center for Medical Device Evaluation notifies the provincial, autonomous regional, or municipal drug regulatory authorities where the applicant is located to conduct the inspection. For domestic Class II medical devices, the provincial, autonomous regional, or municipal drug regulatory authorities where the applicant is located organize the inspection. The inspection focuses on verifying whether the applicant has established a QMS compliant with the Medical Device Production Quality Management Standards and tailored to the product, as well as inspecting design and development, production management, quality control, and the authenticity of testing and clinical trial products. Emphasis is placed on reviewing records related to the design and development process and the production of testing and clinical trial products.

Production License Application

Upon obtaining the registration certificate, apply for a production license from the provincial, autonomous regional, or municipal drug regulatory authorities. Submit the required certification documents along with the registration certificate of the medical device to be produced. For manufacturers of Class I medical devices, file with the municipal drug regulatory authorities.

Market Launch

After obtaining both the registration certificate and production license, the medical device product can be launched on the market.