Regulatory

Announcement on the Results of Defining the Attributes of the Third Batch of Pharmaceutical Device Combination Products

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第190号 Pre-Market 2017-06-27 2017-06-27

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Announcement on the Results of Defining the Attributes of the Second Batch of Pharmaceutical Device Combination Products

Regulation No. Product LifeCycle Issued Date Implemented Date ASHCFDA公告2017年第183号 Pre-Market 2017-03-02 2017-03-02

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product

Announcement on the Results of Defining the Attributes of Pharmaceutical Device Combination Products

Regulation No. Product LifeCycle Issued Date Implemented Date ASHCFDA公告2017年第181号 Pre-Market 2017-02-13 2017-02-13

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product

Interpretation of the Amendment to the Management Measures for Registration of In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170208-2 Supervision & Inspection,Pre-Market 2017-02-08 2017-02-08

Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents IVD

Reply from the General Office of the State Council on the Classification and Definition of Penile Enlargement, Thickening and Stretching Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]480号 Pre-Market 2016-07-01 2016-07-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device

Implementation Regulations of the Drug Administration Law of the People's Republic of China

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第360号国务院令第666号 Pre-Market 2016-06-01 2002-09-15

Status Issued By Level of Legal Effect Product Category Valid State Council … Administrative Regulations IVD Regulated as Pharmaceuticals

Reply from the General Office of the State Administration on Issues Related to Medical Molecular Sieve Oxygen Production

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]117号 Pre-Market 2016-02-25 2016-02-25

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device

Announcement of the State Food and Drug Administration on Standardizing the Registration and Management of Medical Devices Containing Silver Salts

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第225号 Pre-Market 2015-11-09 2015-11-09

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 127 Products, including Multi functional Ultrasound Bone Knife

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]104号 Pre-Market 2015-07-20 2015-07-20

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD

FILTER

Product Life Cycle

Status

Level of Legal Effect

Product Categories

Issuing Organization

Latest Regulations

150 Results

Announcement on the Results of Defining the Attributes of the Third Batch of Pharmaceutical Device Combination Products

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Announcement on the Results of Defining the Attributes of the Second Batch of Pharmaceutical Device Combination Products

Announcement on the Results of Defining the Attributes of Pharmaceutical Device Combination Products

Interpretation of the Amendment to the Management Measures for Registration of In Vitro Diagnostic Reagents

Reply from the General Office of the State Council on the Classification and Definition of Penile Enlargement, Thickening and Stretching Devices

Implementation Regulations of the Drug Administration Law of the People's Republic of China

Reply from the General Office of the State Administration on Issues Related to Medical Molecular Sieve Oxygen Production

Announcement of the State Food and Drug Administration on Standardizing the Registration and Management of Medical Devices Containing Silver Salts

Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 127 Products, including Multi functional Ultrasound Bone Knife