The latest! 117 medical device industry standards to change! What is the impact on the enterprise
On May 12, 2023, the NMPA issued the Announcement of the Comprehensive Department of the NMPA on the 2023 Medical Device Industry Standard Formulation and Revision Plan Project. In accordance with the requirements of the Medical Device Standard Management Measures and the Medical Device Standard Formulation and Revision Work Management Specification, 117 medical device industry standard formulation and revision plan projects were determined for 2023.
Among the announced plans, there are 15 mandatory industry standard system revision projects.
Medical electrical equipment – Part 2-87: Basic safety and basic performance of high-frequency ventilators special requirements for this 1, according to international standards for the development of new industry standards; The remaining 14 items, including electric gastric lavage machines, blood pressure sensors, bone joint implant devices, metal bone screws and bone plates, were revised on the basis of existing industry standards.
There are a total of 102 recommended industry standard development and revision project plans, of which 56 are recommended to develop new industry standards based on international standards, and 46 are revised based on existing industry standards.
- The purpose of revising the latest medical device industry standard is to:
- Strengthening the quality control of medical device products to improve user experience and safety.
- To unify the technical standards and norms of the medical device industry and promote the technological progress and innovation of the industry.
- To enhance the competitiveness of the medical device industry and promote the healthy development of the industry.
For enterprises, the new medical device industry standards will directly affect product development, production, sales and other links. Enterprises need to understand the new standards, according to the requirements of the standard product design, manufacturing and sales. If companies fail to meet the new standards, they may be subject to criticism, penalties and market competition.
#22 standard projects were developed and revised under the leadership of the enterprise!（See the table below）
Standard Project Name
Standard Properties
Preparation
and Revision
Revised
Standard
Number
Adopted International Standard No
Attribution Units
(Standards Committee/
Technical Attribution Point)
Remark
Disposable sterile incision protective Cover
Recommendation
Formulation/Revation
/
/
National Technical Committee
for Standardization of Surgical Instruments
Enterprise led
Standard Project
Materials for surgical instruments – Part 1 Metallic materials Recommendation
Revision YY/T 0294.1-2016 ISO 7153-1:2016 National Technical Committee for Standardization of Surgical Instruments
Enterprise led
Standard Project
Medical nickel titanium alloy powder for
additive manufacturing
Recommendation Formulation / / Medical Additive Manufacturing Technology Medical Device Standardization Technical Attribution Point
Enterprise led
Standard Project
AI medical devices – Quality requirements
and evaluation – Part 5: pre-training model
Recommendation Formulation / / Artificial Intelligence Medical
Device Standardization
Technology Attribution Point
Enterprise led
Standard Project
Blood melting equipment
Recommendation Formulation / / Medical Equipment Sub Technical Committee of the
National Technical Committee for Standardization of Safety in Measurement, Control, and
Laboratory Electrical
Equipment
Enterprise led
Standard Project
17 alpha-hydroxyprogesterone Assay Kit
(Labeled Immunoassay)
Recommendation Formulation / / National Technical Committee for Standardization of Medical Clinical Laboratory and in Vitro Diagnostic system
Enterprise led
Standard Project
Microalbumin assay kit
(immunoturbidimetry)
Recommendation
Formulation / / National Technical Committee for Standardization of Medical Clinical Laboratory and in Vitro Diagnostic system
Enterprise led
Standard Project
Anesthesia and respiratory equipment
Peak expiratory flow meter for evaluating.
lung function in spontaneous breathing
patients
Recommendation Revision YY/T 1438-2016 ISO 23747:2015 National Technical Committee for Standardization of
Anesthesia and Respiratory
Equipment
Enterprise led
Standard Project
EEG electrode
Recommendation Formulation / / Sub Technical Committee of the National Technical
Committee for
Standardization of Electrical
Appliance
Enterprise led
Standard Project
Disposable sterile insulin syringe
Recommendation Revision YY/T 0497-2018 ISO 8537：2016 National Technical Committee for Standardization of Medical Syringes (Needles)
Enterprise led.
Standard Project
Far infrared magnetic therapy Patch (bag)
Recommendation Formulation / / National Technical Committee for Standardization of Medical Appliances physical therapy equipment sub-technical committee Enterprise led
Standard Project
Orthopedic drill instruments – Part 1:
Drill, tap and countersunk milling cutter
Recommendation Revision YY/T 0958.1-2014 ISO 9714-1:2012 National Technical Committee for Standardization of Surgical
Implants and Orthopedic
Devices
Enterprise led
Standard Project
Meniscus suture system of sports medicine implant instrument Recommendation
Revision / / National Technical Committee for Standardization of Surgical
Implants and Orthopedic
Devices
Enterprise led
Standard Project
Special technical specifications for oral
digital X-ray imaging system
Recommendation Formulation / / Medical X Ray Equipment & Appliance Sub Branch for the National Standardization of
Medical Electric Appliance
Technical Committee
Enterprise led
Standard Project
Special technical conditions for medical
X – ray high – voltage generator
Recommendation Formulation / / Medical X Ray Equipment & Appliance Sub Branch for the National Standardization of
Medical Electric Appliance
Technical Committee
Enterprise led
Standard Project
Ophthalmology type A ultrasonic
measuring instrument
Recommendation Revision YY/T 0107-2015 / Medical Sound Sonic Equipment Subbranch for the National Standardization of Medical Electric Appliance Technical Committee
Enterprise led
Standard Project
Contact wound dressings – Part 7:
Carboxymethyl cellulose dressings
Recommendation Formulation / / National working Group on Standardization of Medical
Protective equipment
Enterprise led
Standard Project
Medical sodium hyaluronate dressing
Recommendation Formulation / / National working Group on Standardization of Medical
Protective equipment
Enterprise led
Standard Project
Ophthalmic instruments Projection and
electronic visual acuity charts for visual
acuity measurement
Recommendation Revision YY/T 0764-2009 ISO 10938：2016 National Sub-Technical Committee for Standardization of Medical Optics and Instruments
Enterprise led
Standard Project
Dentistry Dental forceps
Recommendation Revision YY/T 1284.1-2015，YY/T 1284.2-2015，YY/T 1284.3-2015 ISO 15098:2020 Dentistry Equipment & Appliance Subbranch of the National Standardization of Oral Cavity
Material and Appliance Technical Committee.
Enterprise led
Standard Project
Dentistry soft tissue circumferential knife
Recommendation Formulation / ISO 23445:2021 Dentistry Equipment & Appliance Subbranch
of the National
Standardization of Oral Cavity
Material and Appliance
Technical Committee.
Enterprise led
Standard Project
Negative pressure cleaning sterilizer
Recommendation Formulation / / National Technical Committee for Standardization of
Disinfection Technology and
Equipment
Enterprise led
Standard Project
Usually, the recommended industry standard for medical devices is drafted under the leadership of industry associations, professional committees, scientific research institutions and other organizations. However, for enterprises, if they are the main production and sales enterprises of a certain medical device, or have a certain advanced technology or special experience, they may be invited to participate in the formulation of the standard for the medical device.
# There is now a working specification for the drafting of medical device industry standards led by companies!
On April 24, 2023, the NIFDC of NMPA issued a notice: In order to encourage the initiative of enterprises to take the lead in drafting recommended industry standards for medical devices and promote the supply of medical device standards to be more high-quality, timely and diversified, the Working Standards for Enterprises to take the lead in Drafting Recommended Industry Standards for Medical Devices (Trial) has been formulated in accordance with the relevant provisions of the Measures for the Management of
- China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
- Article Source:Device Market
Translated & edited ： Bradyknows
