The cost of MDSAP (Medical Device Single Audit Program) registration for Class II medical devices in the United States can vary depending on several factors, including the certification body you choose and the complexity of the audit. MDSAP is a global audit program recognized by multiple regulatory authorities, including the FDA, and it allows manufacturers to satisfy the regulatory requirements of several countries through a single audit.
Certification Body Fees:
Audit Duration and Complexity:
Additional Costs:
MDSAP Registration Fees (FDA):
The total cost for MDSAP registration for a Class II medical device manufacturer in the U.S. typically ranges from $10,000 to $30,000 for the initial certification audit, with ongoing annual costs for surveillance audits ranging from $5,000 to $15,000 per year. These costs can vary based on the complexity of your operations and the certification body you choose
Contact Us:
Whatsapp or Wechat:+86 15816864648;email address:hito.lin@grzan.cn
Grzan News
Tel:0755-33509057
Adress:Room 103-108, Building B, Block 2, Bangkai Science and Technology Park, No. 9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
E-mail:hitolin@grzan.com
Grzan medical can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact Grzan medical!
Popular keywords:UK authorised representative CTDA registration HSC EU common list Canada cmdcas certification Canadian del certification Australian TGA certification Registered in Hong Kong Medical device certification Variant strain test Who Eul application IVDD CE certification IVDR CE认证 EU authorized representative SRN registration Ukca certification
友 情 链 接:国瑞质量检验中心
Copyright © Grzan medical technology (SZ) Co., Ltd All rights reserved