ISO13485

1. Certification Introduction

ISO13485 is known in Chinese as "Quality Management System for Medical Devices—Requirements for Regulatory Purposes." Since medical devices are special products used for saving lives, healing the injured, and preventing and treating diseases, it is insufficient to regulate them solely based on the general requirements of the ISO9000 standard. Therefore, the ISO organization issued the ISO13485:1996 standard (YY/T0287 and YY/T0288), which sets specific requirements for the quality management systems of medical device manufacturers. This has significantly contributed to ensuring that medical devices are safe and effective.

2. Applicable Entities

Medical product manufacturers and service providers that comply with international, European, and national legal and regulatory requirements, as well as enterprises seeking to implement a documented management system according to this standard.

Enterprises involved in the development, manufacturing, and sales of medical devices that wish to demonstrate their competitive and performance capabilities in international, European, and domestic markets. Suppliers and other service providers within the value-added chain must ensure their products align with customer requirements.

3. Certification Process

ISO13485 certification is divided into initial certification, annual supervision audits, and recertification, as detailed below:

（1）Initial Certification

1. The enterprise completes and submits the "ISO13485 Certification Application Form." Upon receiving the application materials, the certification center conducts a preliminary document review. If the requirements are met, an "Acceptance Notice" is issued.

2. One week before the on-site audit, the composition of the audit team and the audit plan are formally submitted to the enterprise for confirmation.

3. The on-site audit is conducted in accordance with the guidelines for environmental labeling product assurance measures and the corresponding technical requirements for environmental labeling product certification.

4. The audit team prepares a comprehensive evaluation report based on the enterprise’s application materials, on-site audit findings, and the product environmental behavior test report, which is then submitted to the technical committee for review.

5. After receiving the technical committee’s review comments, the certification center consolidates the feedback.

6. The certification center issues the environmental labeling certification certificate to the qualified enterprise and organizes announcements and promotions.

7. If certified enterprises require labels, they can place orders with the certification center. For special printing requirements, an application must be submitted to the certification center for filing.

8. Annual supervision audits are conducted once a year.

（2）Annual Supervision Audits

1. Based on the issuance date of the enterprise’s certification certificate, the certification center develops an annual inspection plan and notifies the enterprise in advance. The enterprise pays the annual supervision fee as per the contract, and the certification center forms an audit team to conduct the on-site inspection.

2. During the on-site audit, if product testing is required, the audit team is responsible for sampling and sealing the products applying for certification, which are then sent to a designated testing agency.

3. The audit team prepares a comprehensive evaluation report based on the enterprise’s materials, audit reports, and product test reports, which is submitted to the general manager of the certification center for approval.

4. Annual supervision audits are conducted once a year.

（3）Recertification

Enterprises with certificates expiring after three years must re-submit the "ISO13485 Certification Application Form" along with relevant materials to the certification center. The remaining certification process is the same as the initial certification.

4. Certification Materials

（1）Product quality certification application and quality system certification application signed by the authorized representative of the applicant;

（2）The applicant’s quality manual, and if necessary, the enterprise’s procedural documents;

（3）Standards for the products applying for certification or covered by the quality system;

（4）Standards declared by the applicant for implementation;

（5）Medical device product registration certificate (copy);

（6）Summary of the entire product production process, including the production workflow and descriptions of special and key processes;

（7）Sales performance and customer feedback over the past three years;

（8）List of major purchased and outsourced components;

（9）Other materials, such as the enterprise’s product catalog, product introductions, promotional materials, and information about organizations and personnel that have provided certification consulting services.

5. Certification Significance

（1）Enhance and improve the enterprise’s management level, mitigate legal risks, and increase the enterprise’s visibility;

（2）Improve and ensure product quality, enabling the enterprise to achieve greater economic benefits;

（3）Facilitate the removal of trade barriers and obtain a passport to enter the international market;

（4）Strengthen product competitiveness and increase market share;

（5）Effectively reduce the risk of product quality incidents or adverse events through robust risk management.