[Summary] Major New Regulations of Medical Device Industry Issued in 2019

Documents

Date

Electronic Declaration of Medical Device Registration (eRPS)

Notice on the implementation of electronic reporting of medical device registration (2019 No. 46)

2019/05/31

Announcement on Technical Guidelines for Electronic Submission of Medical Device Registration Applications (2019 No. 29)

2019/05/31

Notice of the NMPA on Issuing the "Requirements for Examination of Medical Device Product Registration Projects (Trial)" and other documents (2019 No. 42)

2019/07/10

Notice of the NMPA on the requirements for the electronic declaration of medical devices (2019 No. 41)

2019/07/10

Notice regarding matters related to the repeated submission and related submission of electronic declaration for medical device registration (2019 No. 14)

2019/09/19

Unique Device Identification ( UDI )

Notice of the NMPA on issuing the Pilot Work Plan of the UDI System for Medical Devices ([2019] No. 56)

2 019/07/03

Announcement of the NMPA on the Rules for the UDI System of Medical Devices (2019 No. 66)

2019/08/27

Notice of the NMPA on the implementation of the first batch of issues related to the unique identification of medical devices (2019 No. 72)

2019/10/15

Medical Device UDI Database goes online

2 019/12/10

M arketing Authorization Holder (MAH) System

Notice of the NMPA to expand the pilot work of the medical device MAH system ([2019] No. 33)

2 019/08/01

Notice on Implementation Plan of Pilot Work of Medical Device MAH System in Yangtze River Delta Region

2019/10/29

Provincial implementation plan for the medical device MAH system, implementation guidelines for the quality management system for commissioned production, and guidelines for the commissioned production quality agreement

M edical Device Software

Key points of evaluation and related explanations of medical device software capable of deep learning to aid decision making

2019/06/28

Notice of the NMPA on Issuing the Appendix of independent software to the Good Manufacturing Practices for Medical Devices

2019/07/12

Catalog of Medical Devices Exempted from Clinical Trials

Notice of the NMPA on publishing added and revised catalogs of medical devices exempted from clinical trials (2019 No. 91)

2019/12/20

Other Regulations

Announcement on Adjusting the Approval Process for Clinical Trials of Medical Devices (2019 No. 26)

2019/04/01

Announcement on matters related to the adjustment of the definition of the properties of combination products of medicine and medical device (2019 No. 28)

2019/05/31

Announcement of the NMPA on the Provisions on the Supervision and Administration of Customized Medical Devices (Trial) (2019 No. 53)

2019/07/04

Notice of the NMPA on Issuing the Guiding Principles for the Conditional Approval of Medical Devices for marketing (2019 No. 93)

2 019/12/20

Notice of the NMPA on Issuing the Guiding Principles for the Naming of Medical Devices (2019 No. 99)

2019/12/25