GB/T 16886.11-1997
Replaced
DB31/T 1378-2022
Active
Shanghai CityLocal standards
DB31/T 1378-2022 Specification for Class Ⅱ medical device registration service
DB31/T 1378-2022 Specification for Class Ⅱ medical device registration service
Basic Information
Standard Code:
DB31/T 1378-2022
Standard Type:
Local standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2022-10-28
Implement Date:
2023-02-01
Pages:
16 pages
Scope
This document stipulates the general requirements, service process, file review requirements, technical review requirements, administrative approval requirements, expert consultation, communication and service, and document management for the registration of Class II medical devices.
This document is applicable to the evaluation and approval services provided by the medical device approval authorities and review institutions in Shanghai for the registration applicants of Class II medical devices (including in vitro diagnostic reagents managed as medical devices).
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced