Summary of Medical Device Guidelines of 2015 in China

In order to standardize the supervision and strengthen the guidance of medical device registration, CFDA had conformed and released a series of Medical Device Guideline in 2015.
Those guidelines are regard as recommended requirements, not law enforcement. Generally, you shall follow the guideline during research and develop stage, manufacture management stage and registration application stage. It is helpful for you to prepare the dossier and it will be a standardized principle for registration evaluation.

What to include inside Guideline?

The Medical Device Guideline mainly includes as following:
(1). Application scope
(2). Key points of technical review: such as the requirements of product name, inspection, clinical evaluation, instruction and label, etc., reference standards, unit division, and so on.
(3). Core concerns of review

These guidelines enable registrant to proceed with the initial registration or certificate update, the product risk assessment and some other not mentioned in this guideline should be complied with the relevant CFDA regulations.

1. The list of guideline (Final Edition)

No.	Guideline	Issued Data
1	Technical Review Guidelines of Registration for Antibody Reagent and Detection Kit of Estrogen Receptor and Progestrone Receptor	2015.04.17
2	Technical Guidelines of Clinical Evaluation for Medical Device	2015.05.20
3	Technical Review Guidelines of Registration for Image Type Ultrasonic Diagnostic Device with new technology	2015.07.15
4	Technical Review Guidelines of Registration for Hepatitis b virus genotype points detection reagent	2015.07.15
5	Technical Review Guidelines of Registration for Medical Device Software	2015.08.05
6	Technical Review Guidelines of Registration for Nucleic Acid Detection Reagent of Mycobacterium tuberculosis	2015.09.21

2. The list of guideline (Exposure Draft)

NO.	Guideline (Exposure Draft)	Issued Data
1	Guidelines of Clinical Trial for Rigid Gas Permeable Contact Lens for Orthokeratology	2015.01.19
2	Application Materials Guidelines of Registration without Clinic for Sodium Hyaluronate for Facial Injection Filling	2015.01.27
3	Basic Requirements of Clinical Trial for Sodium Hyaluronate for Facial Injection Filling	2015.01.27
4	Technical Review Guidelines of Registration for Reagent of RNA Detection and Genetic Typing of HPV	2015.02.09
5	Technical Review Guidelines of Registration for Auto Chemiluminescence Immunity Analyzer	2015.02.09
6	Compiling Requirements for Electric Safety of Electrical Device for Medical Laboratory	2015.02.16
7	Compiling Requirements for Appendix of technical requirements for Class III In Vitro Diagnostic Reagent	2015.02.16
8	Technical Review Guidelines of Registration for RNA Detection Reagent of Hepatitis C Virus	2015.03.09
9	Application Materials Guidelines of Registration for Medical Device Software	2015.03.09
10	Review of Key Point of Animal Test for patch for Hernia Repair	2015.04.30
11	Technical Review Guidelines of Registration for Animal Derived Medical Device (Revised Edition)	2015.06.10
12	Technical Review Guidelines of Registration for Reagent of Red Blood Cell In Reverse	2015.06.18
13	Guidelines of Clinical Trial for Aorta Stent-Graft System	2015.09.22
14	Guidelines of Clinical Trial for Soft Contact Lens	2015.09.28
15	Technical Review Guidelines of Registration for Posterior Spinal Fixation System	2015.09.28
16	Technical Review Guidelines of Registration for Image Ultrasonic Diagnostic Device (Class III)	2015.09.30
17	Application Materials Guidelines of Registration for Particles Beam Therapeutic System	2015.10.19
18	Technical Review Guidelines of Registration for Disposable Hydrocephalus Shunt Device	2015.10.19
19	Technical Review Guidelines of Registration for Medical X-ray Diagnostic Device (Class III)	2015.10.26
20	Technical Review Guidelines of Registration without Clinic for Centrifugal Blood Component Separation Device	2015.10.26
21	Application Materials Guidelines of Registration for Implantable Pacemaker	2015.10.26
22	Technical Review Guidelines of Registration for Absorbable surgical suture	2015.10.27
23	Technical Review Guidelines of Registration for Respirator	2015.11.02
24	Technical Review Guidelines of Clinical Evaluation for Pulse Oximeter	2015.11.03
25	Technical Review Guidelines of Registration for High Frequency Surgical Device	2015.11.06
26	Technical Review Guidelines of Registration for Intense Pulsed Light Device	2015.11.06
27	Technical Review Guidelines of Registration for Dentistry-Denturebase Polymers Materials	2015.11.06

For More information, please contact Windy@cirs-group.com

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