China SFDA Registration manufacturer & supplier

Medical Device FDA Factory Inspection Consulting

Medical Device FDA Factory Inspection Consulting

American FDA is a public health and services department of the state department. Every year, thousands of inspectors in FDA are sent to 1500

2013-03-20

Explanation on basic requirements of medical device software registration and declaration

Details of medical device software documents are as follow:
1. Basic information
Product identification, safety level, construction and

2013-03-20

Approval consultation for Advertisements of medical devices

Medical devices advertisements approval number application should summit from local medical device advertisement verification body.

2013-03-20

GHTF Medical Device Regulations

In 1992, medical device government competent department and industry representatives from America, European Union, Japan

2013-03-20

Medical Device AIMDD Active Implant Instruction Service Consulting

AIMDD instruction was drawn up in 1990 and was applied for compulsory matters since January, 1995. Therefore, selling active implant medica

2013-03-20

CMDCAS Registration and Certification Consulting

From January 1st, 2003, a new medical device regulation, Canada medical device law is put into practice. All medical devices sol

2013-03-20

EO Sterilization Confirm and Routine Control Training

1. Sterilization medical device packing training
Related standard regulations
Common packing forms
Basic principles and require

2013-03-20

xplanation on basic requirements of medical device software registration and declaration

Details of medical device software documents are as follow:
1. Basic information
Product identification, safety level, construction and funct

2013-03-20

16 Basic Principles of GMP

1. Drugs production enterprises must have enough technicians who are qualified and meet the standard of drugs production. Moreover,

2013-03-20

Disinfection Methods Consulting of Medical Device

In order to provide sterile medical device and Exempt from the patient's infection from each other, medical devices must be disinfected strictly.

2013-03-20

Obtain the Medical Device Manufacturing Enterprise License

Obtain the Medical Device Manufacturing Enterprise License

2013-03-20

The Meaning of Australian TGA registration

The Meaning of Australian TGA registration

2013-03-20

Acceptance Criteria IVD Reagent Registration Procedur

Acceptance Criteria of In Vitro Diagnostics (IVD) Reagent And Registration Procedures For Enterprises

2013-03-20

American Medical Device Authorized Representative

American medical device agent must be American or enterprise agent in America, not a answering machine or a fax machine or just an email address.

2013-03-20

GB 9706. IEC 60601

Safety sgs-cstc of medical electrical equipment place an important role in the process of guiding research and development, inspecting, producing , u

2013-03-20

sterility test medical device

Introduce the newest regulation and standard requirements in quality management process of sterility testing

2013-03-20