Chinese guidance of medical deivce und IVD (2021- up to date)

In General

We will trace all issued general and product specific guidance of medical device and IVD with analysis as of 2021. In additional to general and product specific standards in parallel, it helps you as legal manufacturers to prepare upcoming registration of medical device and IVD with full compliance.

Why is guidance important

The new issued guidance incorporates essential requirements of submission dossier. Oft are details of performance parameters, risk management, type testing, product technical requirement, clinical evaluation, clinical study, labelling, verification and validation specified. It is wise to fulfil these new additional requirements to avoid deficiency in the next product registration.

Unlike standards, guidance of medical device and IVD has no transition period. It means when draft is to published, legal manufacturers should be aware of new requirements. Once the guidance is issued, the new requirements have to be fulfilled in the upcoming and next registration. 

Guidance as a glance (2021- 2022)

Guidance for Registration Review of Epstein-Barr Virus Antibody Detection Reagents

Guidance for Registration Review of Quality Control Products—Research on Value Assignment of Quality Control Products

In vitro diagnostic reagents reference interval determination registration review Guidance

Qualitative detection in vitro diagnostic reagents analytical performance evaluation registration review Guidance

Hepatitis E virus IgM/IgG antibody detection reagent registration review Guidance

Guidance for preclinical registration review of human immunodeficiency virus antigen antibody detection reagents

Issued date: 2022-09-28

Oral retainer registration review Guidance

Guidance for registration review of fungal (1-3)-β-D glucan assay reagents

Guidance for product registration review of dental root canal lubricant cleaner

Guidance for registration review of medical center oxygen supply system

Dental blasting powder registration review Guidance

Guidance for registration review of fecal calprotectin detection reagents

Guidance for registration review of medical sterile ultrasonic gel

Guidance for registration review of medical infrared forehead thermometers

Guidance for Registry Review of Disposable Surgical Caps

Guidance for registration review of cyclosporine and tacrolimus detection reagents

Guidance for registration review of heart-type fatty acid binding protein assay reagents

Acid Oxidation Potential Water Generator Registration Review Guidance

Guidance for Registration Review of Medical Protective Clothing Products

Guidance for the registration review of high-sensitivity cardiac troponin detection reagents

Guidance for Registration Review of Shortwave Therapeutic Devices

Guidance for Registration Review of Medical Air Compressor Units

Guidance for registration review of non-chronic wound dressings

Guidance for product registration review of scar repair materials

Guidance for registration review of single-use EEG electrodes

Guidance for Registration Review of Estradiol Detection Reagents

Guidance for the registration review of prealbumin detection reagents

Guidance for Registration Review of Glycated Hemoglobin Analyzers

Guidance for Registration Review of Vascular Clip Products

Guidance for Product Registration Review of Electroacupuncture Therapy Devices

Guidance for Registration Review of Disposable Sterile Urine Drainage Bags

Guidance for Registration Review of Fibrin Monomer Determination Reagents

Guidance for Product Registration Review of Disposable Incision Protectors

Issued date: 2022-09-15

Guidance for Registration Review of Analytical Performance Evaluation of Quantitative Detection In Vitro Diagnostic Reagents

Issued date: 2022-08-26

Guidance for Registration Review of Clinical Trials of Original Companion Diagnostic Reagents Developed Simultaneously with Antineoplastic Drugs

Issued date: 2022-06-28

PD-L1 Detection Reagent Clinical Trials—Guidance for Registration Review of Results Reproducibility Studies

Issued date: 27.06.2022

Guidance for the registration review of fundus image-assisted diagnosis software for diabetic retinopathy

Issued date: 02.06.2022

Guidance for registration review of CT image-assisted detection software for pulmonary nodules

Issued date: 26.05.2022

Guidance for Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Devices

Issued date: 28.04.2022

Guidelines for the registration review of high-strength and toughness pure titanium orthopaedic internal fixation implants

Issued date: 01.04.2022

Guidance for Stability Studies of Passive Implantable Medical Devices   

Guidance for registration and review of Intravascular Guide Wires Guidelines   

Issued date: 16.03.2022

Guidance for registration and review of Ophthalmic Laser Photocoagulation Machines 

Issued date: 09.03.2022

Guidance for registration and review of Laser Selective Melting Metal Materials for Additive Manufacturing of Prosthodontics

Issued date: 03.03.2022

Guidance for registration and review of Additively Manufactured Polyetheretherketone Implants

Issued date: 02.03.2022  

Guidance for research on uniformity of physical and chemical properties of additively manufactured metal implants   

Issued date: 28.02.2022

Guidance for registration and review of Positron Emission/X-ray Computed Tomography Systems (Special for Digital Technology)  Guidance for registration and review of Biosafety Cabinet   

Guidance for registration and review of Additively Manufactured Polyetheretherketone Implants

Issued date: 19.01.2022  

Guidance for registration Review of drug-device combination products focusing on the role of medical devices   

Guidance for registration and review of Intraocular Lens   

Guidance for registration and review of Single-Use Endoscopic Needles

Guidance for registration and review of Microcatheter   

Guidance for registration and review of Biodegradable Magnesium Metal Orthopedic Implants 

Guidance for registration and review of metal bone plate internal fixation system   

Guidance for registration and review of Disposable High Pressure Contrast Syringe and Accessories

Issued date: 17.01.2022  

1. Guidance for registration and review of fluorescence immunochromatographic analyzers

2. Guidance for registration and review of net atomizers

3. Guidance for registration and review of medical diagnostic X-ray equipment including pediatric applications

4. Guidance for registration and review of ultrasound transcranial Doppler blood flow analyzers

5. Guidance for registration and review of hydrogen peroxide sterilizers

6. Guidance for registration and review of blue light therapy devices for newborns

7. Guidance for registration and review of root canal preparation machines

8. Guidance for registration and review of blood cell analyzers

9. Guidance for registration and review of gait training equipment

10. Guidance for registration and review of pepsinogen I/II detection reagents

11. Guidance for registration and review of Prothrombin time/activated partial thromboplastin time/thrombin time/fibrinogen detection reagent

12. Guidance for registration and review of Retinol binding protein assay kit (immunoturbidimetric method)

13. Guidance for registration and review of folic acid determination reagents

14. Guidance for registration and review of anti-Mullerian hormone determination reagents
Issued date: 28.12.2021

1. Guidance for registration and review of Extracorporeal membrane oxygenation (ECMO) circulation package

2. Guidance for registration and review of single-use abdominal puncture devices

3. Guidance for registration and review of ossicle prosthesis products

4. Guidance for registration and review of artificial ligaments

5. Guidance for registration and review of the pectus excavatum system product" 

Issued date: 20.12.2021

1. Guidance for registration and review of passive surgical devices under arthroscopy

2. Guidance for registration and review of single-use ureteral introducer sheaths

3. Guidance for registration and review of orthodontic filaments

4. Guidance for registration and review of single-use minimally invasive fascial closure devices

5. Guidance for registration and review of anesthesia mask products

6. Guidance for registration and review of non-vascular luminal guidewire products

7. Guidance for registration and review of circumcision staplers

8. Guidance for registration and review of dental desensitizers
Issued date: 16.12.2021

Guidance for registration and review of Nerve and Cardiovascular Surgical Instruments-Knives, Scissors and Needles

Issued date: 01.12.2021

Guidance for registration and review of Medical Device Animal Experimental Research

issued date 27.09.2021

There are two guidances regarding animal test: I Decision-making principle; II Test design, implementation quality assurance. These guidelines are applicable to deciding whether medical devices need to be tested in vivo on live animals, excluding research conducted on non-living animals, isolated tissues or organs. In the first guidance the product code for potencial ainmal testing is given as example.

Guidance for registration and review of Registration of Mammary X-ray System

issued date 27.09.2021

Product code: 06-01-03 and 06-05-12

This guidance is applicable to the mammography machine with product code 06-01-03 and its attached product code 06-05-12 stereo positioning device for mammography. In annex there are valuable examples of 
1. Product composition
2. Risk management
3. Product technical requirements template
4. Configuration table
5. Change product component inspection standards
6. Requirements for clinical evaluation through medical devices of the same variety
7. Clinical trial requirements
8. List of terms and abbreviations

Guidance for registration and review of the registration of vision screeners

issued date 27.09.2021

This guidance applies to vision screeners, not to refractors (including: desktop refractors and hand-held refractors)

Guidance for the technical review of registration of single-use sterile closed clips

issued date 08.05.2021

Product code: 02-06-01

The products applicable are disposable sterile closure clips (hereinafter referred to as closure clips) mainly used to clamp blood vessels or close tubular tissues in surgical operations, including small and medium arteries and veins, bile ducts, etc. It is not suitable for large arteries and large veins.

Guidance for technical review of registration of dental glass ionomer cements

Issued date 08.05.2021

Product code: 17-05-01

It applies to dental glass ionomer cement products. Dental glass ionomer cements are also known as polyalkenate glass cements, glass ionomer cements, glass ionomer cements. They are generally powdery or pasty. They are reacted by fluoroaluminosilicate glass powder and polyalkenic acid aqueous solution, or Cement cured by reacting fluoroaluminosilicate glass powder/polyalkenic acid powder mixture with water or tartaric acid aqueous solution.

Guidance for registration and review of registration of needles for disposable injection pens

Issued date 08.05.2021

Product code: 14-01-06

Needle for injection pen refers to the injection needle product used with injection pen. It is provided aseptically and used for one time. It usually consists of outer sheath, inner sheath, needle tube, needle seat, and sealing dialysis paper (sealing film). The outer sheath and the sealing dialysis paper (sealing film) together constitute the initial packaging of the product. The needle tube is generally a double-ended needle, which is often used for subcutaneous injection of drugs.

Guidance for registration and review of registration of citric acid disinfectant

Issued date 08.05.2021

Product code: 10-04-03

The disinfectant involved in this guidance, the main active ingredient is citric acid, and generally can also contain lactic acid and malic acid, which are used for heating and disinfecting the internal pipelines of the hemodialysis machine. This guidance does not apply to disinfectants that use peracetic acid, sodium hypochlorite, hydrogen peroxide, etc. as the main components to disinfect the internal pipelines of hemodialysis machines.

Guidance for registration and review of registration of human parvovirus B19 IgM/IgG antibody detection reagents

Issued date 15.04.2021

IVD.

Human parvovirus B19 IgM/IgG antibody detection reagent is based on the principle of antigen-antibody reaction, using immunochromatography, enzyme-linked immunoassay, chemiluminescence and other detection techniques to detect B19 IgM/IgG in human samples such as serum or plasma. Reagents for in vitro qualitative detection of IgG antibodies.

Guidance for registration and review of registration of group B streptococcal nucleic acid detection reagents

Issued date 15.04.2021

IVD.

It applies to real-time polymerase chain reaction to detect GBS nucleic acid. It is for in vitro qualitative testing of GBS from human samples such as vaginal swabs, rectal swabs, vaginal and rectal joint swabs from pregnant women or in vitro cultured human samples.

Guidance for registration and review of registration of rotavirus antigen detection reagents

Issued date 15.04.2021

IVD.

It applies to reagents for in vitro qualitative detection of rotavirus in human stool samples or other applicable samples based on the principle of antigen-antibody reaction, and is clinically used for the auxiliary diagnosis of rotavirus infection in patients with acute gastroenteritis

Guidance for update of instructions and technical review of tumor companion diagnostic reagents based on similar therapeutic drugs.

Issued date 15.04.2021

IVD.

The similar therapeutic drugs mentioned in this guidance refer to at least two drugs that are applicable to the same applicable population, the same biomarkers, and the same mechanism of action (such as the same gene mutation, amplification and fusion, etc.) that have been approved for marketing by the National Medical Products Administration Tumor treatment drugs

Guidance for registration and review of real-time fluorescent PCR analyzer

Issued date 15.04.2021

Prouct Code: 22-05-03

It applies to the above real-time fluorescent PCR instruments that perform qualitative or quantitative detection based on real-time fluorescent PCR detection technology, and is suitable for the amplification part of fully automatic equipment. It is not suitable for other nucleic acid analyzers with non-real-time fluorescent PCR amplification principles, nor for digital PCR machines. For non-applicable nucleic acid analyzers, please refer to the relevant applicable provisions of this guidance to prepare registration application materials.

Guidance for registration and review of clinical evaluation of the same type of medical magnetic resonance imaging system

Issued date 01.02.2021

It applies to clinical evaluation of common MR systems as well as MR components of multi-modal systems such as PET/MR systems. Intraoperative MR systems, special MR systems suitable for special parts such as breast/limbs, and special MR systems suitable for specific populations such as pediatrics can also be clinically evaluated according to the applicable requirements of this guidance. It does not apply to the clinical evaluation of MR systems with magnetic field strength greater than 3.0T, software parts with auxiliary decision-making functions, quantitative imaging and magnetic resonance spectroscopy imaging technologies

Guidance for registration and review of registration of cryptococcal capsular polysaccharide antigen detection reagents

Issued date 19.01.2021

IVD. 

It applies to the use of enzyme-linked immunosorbent assay, latex agglutination test and lateral immunochromatography based on the principle of antigen-antibody reaction, for the detection of human samples derived from serum and/or plasma and/or whole blood and/or cerebrospinal fluid. Reagent for in vitro qualitative detection of cryptococcal capsular polysaccharide antigen.

Guidance for registration and review of registration of genetic deafness-related gene mutation detection reagents

Issued date 19.01.2021

IVD. 

It applies to the use of enzyme-linked immunosorbent assay, latex agglutination test and lateral immunochromatography based on the principle of antigen-antibody reaction, for the detection of human samples derived from serum and/or plasma and/or whole blood and/or cerebrospinal fluid. Reagent for in vitro qualitative detection of cryptococcal capsular polysaccharide antigen.

Guidance for registration and review of registration of Mycoplasma pneumoniae IgM/IgG antibody detection reagents

Issued date 19.01.2021

IVD. 

It applies to reagents for the in vitro qualitative detection of Mycoplasma pneumoniae IgM and/or IgG antibodies in human serum, plasma or whole blood by immunochromatography, enzyme-linked immunoassay or chemiluminescence method.

Guidance for registration and review of clinical evaluation of the same type of imaging ultrasound diagnostic equipment

issued date 19.01.2021

Product code 06-07-xx

It applies clinical evaluation of Imaging Ultrasound Diagnostic Equipment.

Contact us

The original guidance is all in Chinese. Write us an email to get the link and the English translation with corresponding cost if needed.

If you need all regulations matching your product code. Upon request we can provide you periodic regulatory update in service as below in customer need with precise gap analysis:

1. Scope (product code with description)
2. Key points of registration review 

• device description
• product technical requirement
• risk management with typical hazards
• biocompatibility
• sterilization
• raw material control
• shelf life, packaging
• clinical evaluation and study,
• labelling
• New: quality management system document