In the first half of 2022, the Center for Medical Device Evaluation, NMPA organized the drafting of and issued 29 guiding principles for medical device registration review in order to strengthen the supervision and guidance of medical device product registration, further improve the quality of registration application data, and increase review efficiency.
S/N
Title
Document No.
1
Guiding Principles for Review of Registration of Drug-Device Combinations with Device Taking Primary Mode of Action
Announcement No. 3 [2022] of the National Medical Products Administration
2
Guiding Principles for Review of Registration of Qualitative, Quantitative, and In Vitro Release Studies of Drugs in Drug-Device Combinations with Device Taking Primary Mode of Action
Announcement No. 3 [2022] of the National Medical Products Administration
3
Guiding Principles for Review of Registration of Single-use High-pressure Angiographic Syringes and Accessories
Announcement No. 4 [2022] of the National Medical Products Administration
4
Guiding Principles for Review of Registration of Metal Bone Plate Internal Fixation System Products (2021 Revision)
Announcement No. 4 [2022] of the National Medical Products Administration
5
Guiding Principles for Review of Registration of Biodegradable Magnesium Metal Orthopedic Implants
Announcement No. 4 [2022] of the National Medical Products Administration
6
Guiding Principles for Review of Registration of Microcatheters
Announcement No. 4 [2022] of the National Medical Products Administration
7
Guiding Principles for Review of Registration of Disposable Endoscopic Injection Needles
Announcement No. 4 [2022] of the National Medical Products Administration
8
Guiding Principles for Review of Registration of Intraocular Lenses
Announcement No. 4 [2022] of the National Medical Products Administration
9
Guiding Principles for Review of Registration of Biosafety Cabinets
Announcement No. 108 [2021] of the National Medical Products Administration
10
Guiding Principles for Review of Registration of Positron Emission Tomography / X-ray Computed Tomography Imaging Systems (Special for Digital Technology)
Announcement No. 108 [2021] of the National Medical Products Administration
11
Guiding Principles for the Preparation of Product Technical Requirements for Medical Devices
Announcement No. 8 [2022] of the National Medical Products Administration
12
Guiding Principles for Review of Registration of Additively Manufactured Polyetheretherketone Implants
Announcement No. 3 [2022] of the Center for Medical Device Evaluation
13
Guiding Principles for Research on Homogeneity of Physicochemical Properties of Additively Manufactured Metal Implants
Announcement No. 4 [2022] of the Center for Medical Device Evaluation
14
Guiding Principles for Review of Registration of Additively Manufactured Selective Laser Melted Metal Materials for Prosthodontics
Announcement No. 5 [2022] of the Center for Medical Device Evaluation
15
Guiding Principles for Review of Registration of Ophthalmic Laser Photocoagulators
Announcement No. 6 [2022] of the Center for Medical Device Evaluation
16
Guiding Principles for Review of Registration of Medical Device Cybersecurity (2022 Revision)
Announcement No. 7 [2022] of the Center for Medical Device Evaluation
17
Guiding Principles for Review of Registration of AI-based Medical Devices
Announcement No. 8 [2022] of the Center for Medical Device Evaluation
18
Guiding Principles for Review of Registration of Medical Device Software
Announcement No. 9 [2022] of the Center for Medical Device Evaluation
19
Guiding Principles for Review of Registration of Intravascular Guidewires
Announcement No. 11 [2022] of the Center for Medical Device Evaluation
20
Guiding Principles for Research on Stability of Passive Implantable Medical Devices (2022 Revision)
Announcement No. 12 [2022] of the Center for Medical Device Evaluation
21
Guiding Principles for Review of Registration of High-strength High-toughness Titanium Orthopedic Internal Fixation Implants
Announcement No. 14 [2022] of the Center for Medical Device Evaluation
22
Guiding Principles for Review of Registration of 2019-nCoV Nucleic Acid Detection Reagents
Announcement No. 18 [2022] of the Center for Medical Device Evaluation
23
Guiding Principles for Review of Registration of 2019-nCoV Antibody Detection Reagents
Announcement No. 18 [2022] of the Center for Medical Device Evaluation
24
Guiding Principles for Review of Registration of 2019-nCoV Antigen Detection Reagents
Announcement No. 18 [2022] of the Center for Medical Device Evaluation
25
Guiding Principles for Review of Registration of Extracorporeal Membrane Oxygenation (ECMO) Equipment
Announcement No. 19 [2022] of the Center for Medical Device Evaluation
26
Guiding Principles for Review of Registration of Pulmonary Nodule CT Image-assisted Detection Software
Announcement No. 21 [2022] of the Center for Medical Device Evaluation
27
Guiding Principles for Review of Registration of Diabetic Retinopathy Fundus Image-assisted Diagnosis Software
Announcement No. 23 [2022] of the Center for Medical Device Evaluation
28
Guiding Principles for Review of Registration of PD-L1 Detection Reagent Clinical Trials - Results Reproducibility Studies
Announcement No. 27 [2022] of the Center for Medical Device Evaluation
29
Guiding Principles for Review of Registration of Clinical Trials of Original Companion Diagnostic Reagents Developed in Parallel to Oncology Drugs
Announcement No. 28 [2022] of the Center for Medical Device Evaluation
Source: Center for Medical Device Evaluation