China's Medical Device Classification and 45-Day Approval Process Highlighted in Recent IPO Filing

Medical DevicesBy Risk Level, from Low to High, and are classified into Class I, Class II, and Class III in sequence.

Class I: Medical devices whose safety and effectiveness can be adequately ensured through routine management.

For example: basic surgical knives (scalpel handles and blades, dermatome, wart removal knife, lancet, scraper, shaving knife, dandruff scraper, pick knife, sharp knife, pedicure knife, manicure knife, dissection knife, etc.).

Class II: Medical devices whose safety and effectiveness must be controlled.

For example:(a) General Examination Instruments (6820): Thermometers, blood pressure monitors;(b) Physical Therapy and Rehabilitation Equipment (6826): Magnetic therapy devices;(c) Clinical Laboratory Analytical Instruments (6840): Home blood glucose analyzers and test strips;(d) Equipment and instruments for operating rooms, emergency rooms, and examination/treatment rooms (6854): Medical Portable Oxygen Concentrator; Handheld Oxygen Generator;(e) Medical hygiene materials and dressings (6864): Use absorbent cotton and medical absorbent gauze;(f) Medical polymer materials and products (6866): Condoms, diaphragms, etc.

Class III: Medical devices that are implanted into the human body; used to support or sustain life; pose potential risks to the human body, and whose safety and effectiveness must be strictly controlled.

For example: (A)、Single-Use Sterile Medical Devices1. Sterile syringes for single use; 2. Infusion sets for single use; 3. Blood transfusion sets for single use; 4. Anesthesia puncture packs for single use; 5. Intravenous infusion needles for single use; 6. Sterile injection needles for single use; 7. Plastic blood bags for single use; 8. Blood collection devices for single use; 9. Burette-type infusion sets for single use. (B),Orthopedic Implant Medical Devices1. Surgical implant joint prostheses (excluding single-use sterile medical devices, hearing aids, contact lenses and care solutions, in vitro diagnostic reagents, Class 6846 implantable materials and artificial organs, Class 6877 interventional devices), etc.

The classification of a medical device for approval is not fixed; it is determined by its safety profile. The China Food and Drug Administration (CFDA) has the authority to change its classification. For instance, masks are generally classified as Class I devices, but they were reclassified as Class II during the SARS outbreak.

Procedures for the Initial Filing of Class I Medical Device Products

Entities establishing a manufacturing enterprise for Class I medical devices shall apply to the municipal-level authority in the locality where the enterprise is situated.Municipal Food and Drug AdministrationFor the filing of Class I medical device production, the food and drug administration department shallVerify the completeness of the documents submitted by the enterprise on-site, and grant record-filing to those meeting the regulatory requirements., and issue the Class I Medical Device Production Record-filing Certificate.

List of Required Documents for Filing Class I Medical Devices:

(1) Copies of the Business License and Organization Code Certificate;

(2) Submit a copy of the filing certificate for the medical devices produced, held by the enterprise submitting the filing;

(3) Copies of identification documents for the legal representative and the person in charge of the enterprise;

(4) Copies of identity documents, academic credentials, and professional title certificates for the heads of production, quality, and technology;

(5) Summary Table of Educational Background and Professional Titles for Personnel in Production Management and Quality Inspection Positions;

(6) Documentation proving the manufacturing site; for sites with special environmental requirements, copies of documentation proving the facilities and environment shall also be submitted;

(7) List of main production equipment and inspection equipment;

(8) Quality manual and procedural documents;

(9) Process Flow Diagram;

(10) Authorization certificate for the handling agent;

(11) Other Supporting Documents.

Approval Procedures for the Initial Registration of Class II and III Medical Devices

For the establishment of manufacturing enterprises for Class II and Class III medical devices, application shall be submitted to the localApply for a production license from the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government.

List of Required Materials for Class II Medical Device Application:

In addition to the list of materials required for the filing of Class I medical devices (excluding Article 2),Submit copies of the medical device registration certificates and product technical requirements held by the applicant enterprise for the devices it manufactures.

Application Process

The initial registration approval for Class II and III medical devices takes 45 days.The Medical Device Production License is valid for five years. Where a medical device manufacturer seeks to renew the license upon its expiration, it shall apply toOriginal Issuing AuthoritySubmit an application for the renewal of the Medical Device Production License. The application will then be re-reviewed in accordance with the procedures for initial applications.

In addition, when applying for Class II and Class III medical devices,Clinical trial data shall be submitted.For medical devices undergoing clinical trials within China, the clinical trial documentation shall include the clinical trial contract, clinical trial protocol, and clinical trial report. For Class III medical devices that are implanted into the human body or developed based on Traditional Chinese Medicine (TCM) theories and are not yet available on the market, the clinical trial protocol shall be filed with the medical device technical review institution.

Disclaimer: This article is primarily for popular science education. Enterprises applying for a medical device license should refer to the Measures for the Supervision and Administration of Medical Device Production (Order No. 7 of the China Food and Drug Administration), issued on July 30, 2014, on the official website of the China Food and Drug Administration. Please note that the Measures for the Supervision and Administration of Medical Device Production issued in 2004 has been abolished; please ensure you are referring to the correct version.