- Medical instrument international certification
- 【Brief】：Medical equipment is directly related to people's life and health, the countries in the world on medical products have made the more strict laws and regulations of other products, with high standard and high safety of medical products to better serve the people.
- 【Series】：Medical instruments
- Description
Medical equipment is directly related to people's life and health, the countries in the world on medical products have made the more strict laws and regulations of other products, with high standard and high safety of medical products to better serve the people. As the authority of the CNAS professional medical equipment third party testing agency, and DNV, TUV, MED/CERT, UL, NQA, AP and many other international cooperation announcement mechanism is good, for medical products in the European and international market of professional testing, consulting, certification service Medical Equipment Directive (MDD 93/42 EEC), MDD command suitable for most sales of medical equipment to enter the eu. It is divided into 6 categories according to different requirements, which are evaluated by the certification bodies.
level
design phase
Production stage
Class I
Self satisfaction statement
Self satisfaction statement
Class I (measurement function)
Self satisfaction statement
Announcement body
Class I (sterilization)
Self satisfaction statement
Announcement body
II a
Self satisfaction statement
Announcement body
IIｂ
Announcement body
Announcement body
Category III
Announcement body
Announcement body
The directives issued by the European Community on medical device products are as follows:
Name
CE Ref. directive
Product example
Implantable medical device directive
(implantable medical device)
90/385/EEC
heart pacemaker
General medical device directive
93/42/EEC
Monitor, electric wheelchair,
ECG and ultrasoundIn vitro diagnostic medical device directive
Laboratory equipment for extracting laboratory tests and diagnostics of human secretions
98/79/EC
Urine analyzer, enzyme marker, blood glucose meter
2. in vitro diagnostic instruction IVDD98/79 CE certification: with the in vitro diagnostic medical device directive (IVDD 98/79/EC) adopted in Europe, the requirements of the medical device directive in vitro diagnostics are mandatory for all EU member states.
3. international standard ISO 13485 is an independent quality management system standard used in the medical device industry. It allows you to respond flexibly to market and international competition. Global pass testing, as the third party certification authority, integrates resources with international certification bodies and domestic consulting companies to provide the support you need. This international standard defines the quality assurance system for the design / development, production, customer service and assembly of medical devices. It includes all the GMP principles applied to the manufacture of medical devices (GMP=, good manufacturing management practices). On the basis of the requirements of ISO 9001, ISO 13485 must also meet a series of additional standards.
4. FDA510 (K): pre listing notification 510 (K) is the most common method for approval of medical products or in vitro diagnostic products in the United states. As a third party testing organization, global pass testing can carry out 510 (k) consulting, testing and certification services for most II instruments.
5. American FDA synopsis: Food and Drug Administration (FDA) is under the Services Of Health (U.S.Department and Human)
6. domestic SFDA in China domestic sales and use of medical devices shall be in accordance with the "SFDA" measures for the administration of medical device registration provisions are not allowed to apply for registration, medical device registration, may not be sold or used.
In addition, the following 7 types of medical device products must also obtain the FDA's medical device registration certificate and CCC certification:
Medical X ray diagnostic equipment
Hemodialysis devices
Hollow fiber dialyzer
Extracorporeal circulation of blood purification equipment
• electrocardiograph
Implantable heart pacemaker
Artificial heart lung machine
Common products
※The in vitro diagnostic equipment (IVD)
※The general medical equipment (MDD)
※The medical X - ray diagnostic equipment
※A blood dialysis apparatus
※The hollow fiber dialyzer
※The blood purification pipeline extracorporeal circulation device
※The electrocardiograph
※The implantable cardiac pacemaker
※The artificial heart lung machine
