FDA 医疗器械注册难不难

  和国内注册一样，精通了FDA的注册流程、法规要求，掌握了申报产品的特性、性能、注册要求，FAD医疗器械产品列名LISTING，注册 REGISTRATION510(K)如同国内医疗注册一样并没有想像中的难，FDA每完成一步工作都有邮件沟通和确认，时间大致可以掌控。对有FDA医疗器械注册经验的小伙伴来说其实还不是很难，真所谓知之非难，行之不易。

1、FDA CDRH邮件通知

Successful2023 Medical Device EstablishmentRegistration

• 发件人：

CDRH Registration and Listing

• 收件人：

bcc2015319@163.com

• 时   间：

2023年04月14日 03:23 (星期五)

• 附   件：

2个 (Header.jpg 等) 查看附件

Dear Peng YunFan:

This e-mail provides confirmation that the annual registration forthe following medical device establishment has been successfullycompleted for 2023:

Registration Number:
Owner Operator Number: 10087731
SHANDONG LIANGYUE MEDICAL DEVICE TECHNOLOGY CO.,LTD
Building A4, Tancheng Hi-Tech Electronics Industrial Park, Q
LinYi, Shandong 276100
CHINA

If you do not see a registration number assigned to theestablishment and your establishment previously had one, pleasesend an email to reglist@cdrh.fda.gov andinclude the registration number you believe is assigned to yourestablishment. We will review and determine if a duplicateregistration has been created for your establishment.

Your registration is valid until December 31, 2023. Registrationfor 2024 will be conducted between October 1 and December 31,2023.

Please note that registering your device facility and listing yourdevices does not, in any way, constitute FDA approval of yourfacility or your devices.

Should you have any questions, please send an e-mail to the CDRHRegistration and Listing Helpdesk at reglist@cdrh.fda.gov.

CDRH Registration and Listing Helpdesk
Imports & Registration and Listing Team
Division 2 Establishment Support
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Tel: 301-796-7400, Option 1
Email: reglist@cdrh.fda.gov

PIN 50402427 Successfully Created

·      发件人：

userfees+

·      收件人：

我

·      时   间：

2023年03月25日 13:36 (星期六)

Hello,

Thank you for completing step one of the payment process for your2023 Establishment Registration Fee.

For your reference, your Payment Identification Number (PIN)is: 50402427.

Now that you have received your PIN, you can proceed to make yourpayment. Once you make your payment, allow at least 2-3 businessdays for FDA to process online payments. It takes at least 7-10business days for FDA to process paper checks and wiretransfers.

After your payment has been processed you will receive an emailabout next steps.

Online Payments - PleaseNote: If you submit your payment online you willreceive a real-time tracking email, indicating that your paymenthas been submitted for processing. This Pay.gov paymentconfirmation email is not yourPCN; please allow 2-3 business days for the FDA to process youronline payment. You will receive a second email from FDA once yourPCN is available.

Thank you,
FDA Office of Financial Management

更多美国FDA医疗器械产品注册备案常见问题及方案解决请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。