1、 International General Basic Standards (Safety and Performance)

These standards are the technical cornerstone of medical device regulations in various countries and are often used as the testing basis for certification.

1. Basic safety and general requirements

• ISO 14971- Risk Management for Medical Devices. This is the most fundamental of all standards, requiring manufacturers to identify risks from the design source and take control measures.

• ISO 13485- Quality Management System for Medical Devices. It is a prerequisite for certification, proving that the enterprise has the ability to produce qualified products stably.

• IEC 60601 series - General requirements for safety of medical electrical equipment. Applicable to all active (live) medical devices, covering electrical safety, mechanical safety, radiation protection, etc. Its derived standards include IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-8 (Alarm Systems), etc.

• ISO 10993 series - Biological evaluation of medical devices. Assess whether materials in contact with the human body cause toxicity, irritation, sensitization, genetic toxicity, etc. Conduct corresponding tests based on the contact site and duration (such as cytotoxicity, intradermal reactions, post implantation reactions, etc.).

2. Specific product standards (for example)

• Passive implants: such as ISO 5840 (artificial heart valves), ISO 14630 (orthopedic implants), ISO 25539 (vascular stents).

• In vitro diagnostics (IVD): ISO 15197 (blood glucose monitoring systems), ISO 18113 (IVD reagent instructions), CLSI EP series (American clinical laboratory standards commonly used for performance evaluation).

• Software/Artificial Intelligence (SaMD): IEC 62304 (Medical Device Software Lifecycle), IEC 82304-1 (Health Software Safety), and AI Model Transparency and Generalization Capability Evaluation (currently there is no unified international standard, but the EU AI Act and FDA's AI/ML Action Plan are being filled in).

2、 Certification system and core standards for the main target market

To go public, approval from local regulatory authorities or a declaration of conformity must be obtained.

Attention: The above standard numbers will be updated over time (for example, China will fully implement GB 9706.1-2020 from 2020, replacing the old version). Please check the latest version before applying.

3、 Key testing items (by technical field)

Regardless of the market, the following tests occur frequently:

1. Electrical safety (applicable to active devices)

• Grounding, insulation, withstand voltage, leakage current - according to IEC 60601-1.

• Electromagnetic compatibility (EMC) - according to IEC 60601-1-2. Test radiation emission and immunity (ESD, electrical fast transients, surges, etc.).

• Performance parameters: such as heart rate accuracy of the monitor and flow rate stability of the infusion pump.

2. Biocompatibility (applicable to materials that come into contact with the human body)

• Select the test items according to the "endpoint matrix" of ISO 10993-1:

  • Cytotoxicity, sensitization, and intradermal reactions (basic three)

  • Systemic toxicity, subchronic toxicity, genetic toxicity, and post implantation reactions (based on exposure time and depth)

• Chemical characterization (ISO 10993-18): Analyze leachables for exemption from certain animal experiments.

3. Sterility and Microbiology

• Aseptic testing (according to pharmacopoeia, such as Chinese Pharmacopoeia 1105, USP<71>, EP 2.6.1)

• Endotoxin test (such as USP<85>, gel method or dynamic color method)

• Sterilization validation (EO residue: ISO 10993-7; Radiation dose setting: ISO 11137; Damp heat: ISO 17665)

4. Packaging and stability

• Accelerated aging (ASTM F1980/domestic YY/T 0681.1) is used to determine shelf life.

• Packaging integrity (dye penetration, bubble method, sealing strength).

• Transportation simulation (ISTA or ASTM D4169).

5. Software and Network Security

• IEC 62304 classifies software security levels (A, B, C) and requires the provision of development documents, risk management, and testing reports.

• Cybersecurity: 21 CFR 820 (US), EU MDR Appendix I Chapter 17, as well as AAMI TIR57, IEC 81001-5-1, etc. Require threat modeling, vulnerability scanning, and penetration testing.

4、 Overview of Testing and Certification Process (Taking China NMPA as an Example)

1. Determine classification: Determine Class I/II/III based on the "Classification Catalogue of Medical Devices" and "Classification Rules".

2. Quality Management System: Establish a system that complies with ISO 13485 or Good Manufacturing Practice (GMP) for the production of medical devices.

3. Sample testing: Entrust testing institutions with national CMA/CNAS qualifications (such as China National Medical Products Administration, Shanghai/Tianjin/Guangdong Medical Device Testing Institute) to complete type testing according to product technical requirements.

4. Clinical evaluation: Low risk products can be compared or exempted with the same variety; High risk products require clinical trials (note the latest "Technical Guidelines for Clinical Evaluation of Medical Devices").

5. Registration application: Submit materials to NMPa, and the technical review usually takes 90-120 working days.

6. After obtaining the registration certificate, apply for a production license before going public.

For exports, the process is similar but with the corresponding certification body of the target country (such as FDA through electronic submission, CE-MDR through notified bodies).

5、 Frequently Asked Questions and Latest Trends

• AI Medical Devices (AIaMD): FDA releases' Scheduled Change Control Plan '; The China National Medical Products Administration has released the "Guidelines for Registration and Review of Artificial Intelligence Medical Devices"; Testing involves data quality control, generalization ability evaluation, and algorithm adversarial testing.

• Combination devices (drug device combination): such as drug coated catheters and antibacterial sutures. In addition to the equipment label, it is also necessary to meet the relevant regulations of the drug (in China, joint evaluation by the NMPA Drug Evaluation Center is required).

• Cybersecurity has become a 'mandatory requirement'. Each country requires the provision of SBOM (Software Bill of Materials), vulnerability mitigation plan, and cybersecurity manual.