Mới đây, chính phủ ban hành NĐ98-2021/NĐ-CP về quản lý trang thiết bị y tế. Từ 2022, các thiết bị y tế loại A, B sẽ phải làm công bố ở các Sở Y tế. Hệ thống BYT đã update phần công bố tiêu chuẩn áp dụng TBYT Loại B tuy nhiên tới 01.01.2022 mới nộp được nhé ạ.
Em xin gửi anh chị hồ sơ công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế loại A, B. Em Hà My 0949.755.806 nhận tư vấn, sửa, làm mới hồ sơ công bố tiêu chuẩn áp dụng TBYT loại A,B trên khắp cả nước.
Hồ sơ công bố tiêu chuẩn áp dụng đối với trang thiết bị y tế thuộc loại A, B bao gồm:
1. Văn bản công bố tiêu chuẩn áp dụng của trang thiết bị y tế thuộc loại A, B.
2. Giấy chứng nhận đạt tiêu chuẩn quản lý chất lượng ISO 13485 còn hiệu lực tại thời điểm nộp hồ sơ.
3. Giấy ủy quyền của chủ sở hữu trang thiết bị y tế cho tổ chức đứng tên công bố tiêu chuẩn áp dụng còn hiệu lực tại thời điểm nộp hồ sơ, trừ trường hợp theo quy định tại điểm a khoản 1 Điều 25 Nghị định này.
4. Giấy xác nhận đủ điều kiện bảo hành do chủ sở hữu trang thiết bị y tế cấp, trừ trường hợp trang thiết bị y tế sử dụng một lần theo quy định của chủ sở hữu trang thiết bị y tế hoặc có tài liệu chứng minh không có chế độ bảo hành.
5. Tài liệu mô tả tóm tắt kỹ thuật trang thiết bị y tế bằng tiếng Việt, kèm theo tài liệu kỹ thuật mô tả chức năng, thông số kỹ thuật của trang thiết bị y tế do chủ sở hữu trang thiết bị y tế ban hành.
Riêng đối với thuốc thử, chất hiệu chuẩn, vật liệu kiểm soát in vitro: tài liệu kỹ thuật bằng tiếng Việt kèm theo tài liệu về nguyên vật liệu, về an toàn của sản phẩm, quy trình sản xuất, các báo cáo nghiên cứu lâm sàng và tiền lâm sàng bao gồm báo cáo độ ổn định.
6. Giấy chứng nhận hợp chuẩn theo quy định hoặc bản tiêu chuẩn sản phẩm do chủ sở hữu trang thiết bị y tế công bố.
Riêng đối với trang thiết bị y tế sản xuất trong nước bổ sung kết quả đánh giá các thông số hóa, lý, vi sinh và các thông số khác do cơ sở đủ điều kiện theo quy định của pháp luật về đánh giá sự phù hợp cấp hoặc Giấy chứng nhận đánh giá chất lượng do cơ quan có thẩm quyền của Việt Nam cấp đối với trang thiết bị y tế chẩn đoán in vitro. Kết quả đánh giá phải phù hợp với tiêu chuẩn mà chủ sở hữu trang thiết bị y tế công bố.
7. Tài liệu hướng dẫn sử dụng của trang thiết bị y tế.
8. Mẫu nhãn sẽ sử dụng khi lưu hành tại Việt Nam của trang thiết bị y tế.
9. Giấy chứng nhận lưu hành tự do còn hiệu lực tại thời điểm nộp hồ sơ đối với trang thiết bị y tế nhập khẩu.
Yêu cầu đối với hồ sơ công bố tiêu chuẩn áp dụng
1. Hồ sơ công bố tiêu chuẩn áp dụng làm thành 01 bộ.
2. Yêu cầu đối với một số giấy tờ trong bộ hồ sơ công bố tiêu chuẩn áp dụng:
a) Đối với Giấy chứng nhận đạt tiêu chuẩn quản lý chất lượng: Nộp bản gốc hoặc bản sao có chứng thực hoặc bản sao có xác nhận của tổ chức đứng tên công bố tiêu chuẩn áp dụng.
Trường hợp Giấy chứng nhận đạt tiêu chuẩn quản lý chất lượng không bằng tiếng Anh hoặc không bằng tiếng Việt thì phải dịch ra tiếng Việt. Bản dịch phải được chứng thực theo quy định của pháp luật.
b) Đối với giấy ủy quyền của chủ sở hữu trang thiết bị y tế và giấy xác nhận cơ sở đủ điều kiện bảo hành:
– Đối với trang thiết bị y tế sản xuất trong nước: Nộp bản gốc hoặc bản sao có chứng thực;
– Đối với trang thiết bị y tế nhập khẩu: Nộp bản đã được hợp pháp hóa lãnh sự hoặc bản sao có chứng thực của bản đã được hợp pháp hóa lãnh sự.
c) Đối với Giấy chứng nhận hợp chuẩn hoặc Bản tiêu chuẩn mà chủ sở hữu trang thiết bị y tế công bố áp dụng: Nộp bản gốc hoặc bản sao có xác nhận của tổ chức đứng tên công bố tiêu chuẩn áp dụng.
Trường hợp Bản tiêu chuẩn không bằng tiếng Anh hoặc không bằng tiếng Việt thì phải dịch ra tiếng Việt. Bản dịch phải được chứng thực theo quy định của pháp luật.
d) Đối với tài liệu hướng dẫn sử dụng của trang thiết bị y tế: Nộp bản bằng tiếng Việt có xác nhận của tổ chức đứng tên công bố tiêu chuẩn áp dụng, kèm theo bản gốc bằng tiếng Anh do chủ sở hữu trang thiết bị y tế ban hành đối với trang thiết bị y tế nhập khẩu. Trường hợp tài liệu hướng dẫn sử dụng không bằng tiếng Anh hoặc không bằng tiếng Việt thì phải dịch ra tiếng Việt. Bản dịch phải được chứng thực theo quy định của pháp luật.
đ) Đối với mẫu nhãn: Nộp bản mẫu nhãn có xác nhận của tổ chức đứng tên công bố tiêu chuẩn áp dụng. Mẫu nhãn phải đáp ứng các yêu cầu theo quy định của pháp luật về nhãn hàng hóa.
e) Đối với giấy chứng nhận lưu hành tự do: Nộp bản đã được hợp pháp hóa lãnh sự hoặc bản sao có chứng thực của bản đã được hợp pháp hóa lãnh sự.
Trường hợp giấy chứng nhận lưu hành tự do không bằng tiếng Anh hoặc không bằng tiếng Việt thì phải dịch ra tiếng Việt. Bản dịch phải được chứng thực theo quy định của pháp luật.
g) Đối với bản kết quả đánh giá các thông số hóa, lý, vi sinh và các thông số khác do cơ sở đủ điều kiện theo quy định của pháp luật về đánh giá sự phù hợp cấp hoặc Giấy chứng nhận đánh giá chất lượng do cơ quan có thẩm quyền của Việt Nam cấp đối với trang thiết bị y tế chẩn đoán in vitro: Nộp bản gốc hoặc bản sao có chứng thực
Doanh nghiệp cần hỗ trợ thủ tục Nhập khẩu cho các loại hàng y tế thì liên hệ em tư vấn nhé:
Ms Hà My: 0949.755.806 (zalo/tel)
Mail: mynh@airseaglobalgroup.com.vn
Add: Phòng 2412 tòa Eurowindow 27 Trần Duy Hưng, Cầu Giấy, Hà Nội.
Hi there, just became aware of your blog through
Google, and found that it is truly informative.
I am gonna watch out for brussels. I’ll appreciate if you continue this in future.
Numerous people will be benefited from your writing.
Cheers!
Very interesting info!Perfect just what I was searching
for!.
I was reading through some of your articles on this internet site and I think this internet site is real instructive!
Keep on putting up. Euro travel
Aw, this was an extremely nice post. Taking a few minutes and actual effort to generate a good article… but what can I say… I hesitate a whole lot and don’t seem to get anything done.
Excellent write-up. I definitely appreciate this site. Stick with it!
I want to to thank you for this great read!! I definitely enjoyed every bit of it. I’ve got you book-marked to check out new stuff you post…
Greetings! Very useful advice in this particular article! It is the little changes that produce the biggest changes. Thanks for sharing!
Good post. I learn something new and challenging on blogs I stumbleupon everyday. It’s always useful to read content from other authors and use a little something from other sites.
This website certainly has all the information and facts I wanted concerning this subject and didn’t know who to ask.
Excellent site you have got here.. It’s difficult to find high quality writing like yours these days. I truly appreciate people like you! Take care!!
That is a really good tip particularly to those new to the blogosphere. Short but very precise info… Many thanks for sharing this one. A must read article!
Aw, this was an extremely good post. Finding the time and actual effort to produce a really good article… but what can I say… I put things off a whole lot and don’t manage to get anything done.
Hello there, There’s no doubt that your web site may be having web browser compatibility issues. When I look at your blog in Safari, it looks fine however, when opening in Internet Explorer, it’s got some overlapping issues. I simply wanted to provide you with a quick heads up! Besides that, fantastic blog!
Hi there! I simply wish to give you a huge thumbs up for your excellent info you’ve got here on this post. I am returning to your web site for more soon.
Discovering Sugar Defender has been a game-changer for me, as I have actually constantly been vigilant regarding handling my
blood sugar levels. I now feel equipped and positive in my capability to preserve healthy levels, and my
most current health checks have mirrored this progress. Having
a credible supplement to enhance my a massive resource of comfort, and I’m genuinely happy for the considerable difference Sugar Protector has actually
made in my overall health.
Integrating Sugar Protector right into my day-to-day regimen overall health.
As someone that prioritizes healthy consuming, I appreciate the additional
defense this supplement provides. Considering that beginning to take it, I
have actually discovered a significant improvement in my energy levels and a considerable reduction in my desire for harmful treats such a such a profound impact on my every day life.
Uncovering Sugar Protector has been a game-changer
for me, as I have actually always been vigilant regarding managing my blood sugar
levels. I currently really feel equipped and positive in my
ability to maintain healthy levels, and my most current checkup have actually reflected this progress.
Having a trustworthy supplement to match my a huge resource
of comfort, and I’m truly thankful for the substantial difference Sugar Protector has actually
made in my overall well-being.
As someone who’s always been cautious regarding my blood glucose, locating Sugar Protector has been a relief.
I really feel a lot extra in control, and my current examinations have revealed favorable enhancements.
Understanding I have a dependable supplement to support my regular provides me peace of mind.
I’m so grateful for Sugar Defender’s effect on my wellness!
Uncovering Sugar Defender has actually been a game-changer for me, as I have actually constantly been vigilant
about handling my blood glucose degrees. With this supplement, I really feel
equipped to take charge of my wellness, and my most recent clinical
exams have shown a significant turn-around. Having a trustworthy ally in my
edge supplies me with a sense of security and confidence, and I’m
deeply glad for the extensive difference Sugar Defender has made in my wellness.
There is definately a great deal to know about this subject. I love all the points you have made.
Hi! Do you know if they make any plugins to help
with Search Engine Optimization? I’m trying to get
my website to rank for some targeted keywords but I’m not seeing very
good gains. If you know of any please share.
Many thanks! I saw similar text here: Wool product
Very good information. Lucky me I discovered your website by accident (stumbleupon). I have bookmarked it for later!
sugar defender reviews Incorporating Sugar Defender into
my day-to-day routine total well-being. As someone that focuses on healthy
consuming, I appreciate the extra defense this supplement provides.
Because beginning to take it, I have actually observed
a significant enhancement in my power levels and
a substantial reduction in my wish for harmful treats such a such an extensive influence on my day-to-day live.
I’m impressed, I must say. Rarely do I encounter a blog that’s both educative and engaging, and without a doubt, you’ve hit the nail on the head. The problem is something not enough men and women are speaking intelligently about. I am very happy that I came across this in my search for something regarding this.
This is a topic which is close to my heart… Many thanks! Exactly where are your contact details though?
This is a topic that is near to my heart… Thank you! Where are your contact details though?
I’m impressed, I have to admit. Rarely do I encounter a blog that’s both educative and entertaining, and let me tell you, you’ve hit the nail on the head. The problem is something that too few folks are speaking intelligently about. I am very happy that I stumbled across this during my search for something concerning this.
You ought to be a part of a contest for one of the best blogs on the web. I will highly recommend this web site!
Oh my goodness! Amazing article dude! Many thanks, However I am going through issues with your RSS. I don’t know the reason why I cannot subscribe to it. Is there anybody else getting identical RSS issues? Anyone who knows the solution can you kindly respond? Thanx!
You are so awesome! I do not believe I’ve read something like this before. So nice to discover another person with a few genuine thoughts on this topic. Really.. many thanks for starting this up. This website is one thing that is required on the internet, someone with a bit of originality.
Your style is very unique compared to other people I have read stuff from. I appreciate you for posting when you’ve got the opportunity, Guess I’ll just book mark this page.
You are so awesome! I do not believe I’ve read something like that before. So great to discover somebody with some original thoughts on this issue. Seriously.. thanks for starting this up. This website is something that is needed on the internet, someone with some originality.
bookmarked!!, I love your website.
The next time I read a blog, I hope that it doesn’t disappoint me just as much as this particular one. I mean, Yes, it was my choice to read, nonetheless I truly believed you would probably have something useful to say. All I hear is a bunch of whining about something you could fix if you were not too busy looking for attention.
Way cool! Some extremely valid points! I appreciate you writing this write-up and the rest of the website is extremely good.
Everything is very open with a really clear explanation of the issues. It was really informative. Your site is extremely helpful. Thanks for sharing!
Pretty! This was an incredibly wonderful post. Many thanks for providing these details.
Your style is really unique compared to other people I have read stuff from. Thank you for posting when you’ve got the opportunity, Guess I will just bookmark this site.
After I initially left a comment I appear to have clicked the -Notify me when new comments are added- checkbox and from now on whenever a comment is added I receive four emails with the exact same comment. Is there a way you are able to remove me from that service? Thank you.
A motivating discussion is worth comment. There’s no doubt that that you need to write more about this issue, it may not be a taboo subject but usually people do not talk about these issues. To the next! Best wishes.
This page certainly has all of the information I wanted concerning this subject and didn’t know who to ask.
Spot on with this write-up, I seriously believe this web site needs a lot more attention. I’ll probably be returning to read more, thanks for the information!
This is a topic which is near to my heart… Many thanks! Where are your contact details though?
Good post. I learn something new and challenging on sites I stumbleupon everyday. It will always be helpful to read articles from other writers and practice a little something from other sites.
Good post. I learn something totally new and challenging on websites I stumbleupon on a daily basis. It’s always exciting to read through articles from other writers and use a little something from their websites.
I couldn’t refrain from commenting. Very well written.
I blog frequently and I really appreciate your information. The article has really peaked my interest. I will book mark your site and keep checking for new information about once a week. I opted in for your Feed too.
After looking at a handful of the articles on your blog, I honestly appreciate your way of blogging. I saved as a favorite it to my bookmark website list and will be checking back soon. Take a look at my web site as well and let me know what you think.
Aw, this was a really good post. Spending some time and actual effort to create a very good article… but what can I say… I put things off a lot and don’t seem to get nearly anything done.
Good information. Lucky me I came across your website by accident (stumbleupon). I’ve saved it for later!
May I simply just say what a relief to find someone who really knows what they’re talking about on the web. You actually understand how to bring a problem to light and make it important. A lot more people really need to look at this and understand this side of your story. I was surprised that you aren’t more popular since you surely possess the gift.
Good write-up. I absolutely appreciate this website. Keep it up!
I truly love your website.. Very nice colors & theme. Did you make this web site yourself? Please reply back as I’m attempting to create my own blog and would love to know where you got this from or just what the theme is called. Many thanks!
Everyone loves it when folks come together and share thoughts. Great site, keep it up.
Hi! I could have sworn I’ve visited your blog before but after looking at some of the posts I realized it’s new to me. Anyhow, I’m certainly happy I came across it and I’ll be bookmarking it and checking back often!
An outstanding share! I’ve just forwarded this onto a co-worker who has been conducting a little homework on this. And he actually ordered me dinner due to the fact that I found it for him… lol. So let me reword this…. Thank YOU for the meal!! But yeah, thanks for spending the time to talk about this subject here on your internet site.
I used to be able to find good advice from your articles.
This blog was… how do I say it? Relevant!! Finally I’ve found something which helped me. Cheers!
I was able to find good advice from your blog posts.
You ought to be a part of a contest for one of the greatest blogs online. I most certainly will highly recommend this web site!
I seriously love your site.. Pleasant colors & theme. Did you create this site yourself? Please reply back as I’m hoping to create my own blog and would love to know where you got this from or what the theme is named. Thanks!
Spot on with this write-up, I seriously believe this web site needs much more attention. I’ll probably be back again to see more, thanks for the information.
There is definately a lot to find out about this subject. I love all of the points you made.
Hello there! I simply wish to offer you a huge thumbs up for the excellent info you have got here on this post. I’ll be coming back to your website for more soon.
I really like reading an article that can make people think. Also, many thanks for allowing for me to comment.
I enjoy looking through a post that can make men and women think. Also, many thanks for allowing for me to comment.
An intriguing discussion is worth comment. I do think that you should publish more on this subject matter, it may not be a taboo subject but typically people don’t talk about such issues. To the next! Cheers!
I was able to find good info from your articles.
It’s hard to find well-informed people in this particular topic, however, you sound like you know what you’re talking about! Thanks
I’m more than happy to uncover this site. I need to to thank you for your time for this particularly fantastic read!! I definitely enjoyed every little bit of it and I have you book marked to look at new stuff on your blog.
Your style is very unique compared to other people I’ve read stuff from. I appreciate you for posting when you’ve got the opportunity, Guess I will just book mark this web site.
A fascinating discussion is worth comment. I think that you ought to publish more on this issue, it may not be a taboo subject but generally people don’t talk about these subjects. To the next! Many thanks!
I like it when people come together and share ideas. Great website, keep it up!
Hi! I could have sworn I’ve been to this site before but after going through some of the articles I realized it’s new to me. Nonetheless, I’m certainly pleased I found it and I’ll be bookmarking it and checking back frequently!
I really like it when people get together and share thoughts. Great site, continue the good work!
Good post. I am facing some of these issues as well..
Hey there! I simply would like to offer you a huge thumbs up for the great information you have here on this post. I’ll be returning to your website for more soon.
I used to be able to find good information from your blog posts.
I really like reading through a post that will make men and women think. Also, thanks for allowing me to comment.
Good post. I learn something totally new and challenging on blogs I stumbleupon on a daily basis. It’s always exciting to read articles from other authors and use something from their sites.
Hey there! I simply want to offer you a big thumbs up for your excellent information you have here on this post. I am coming back to your site for more soon.
Hi, I do believe this is an excellent web site. I stumbledupon it 😉 I’m going to revisit yet again since i have book-marked it. Money and freedom is the greatest way to change, may you be rich and continue to help others.
I really love your blog.. Pleasant colors & theme. Did you create this website yourself? Please reply back as I’m looking to create my own blog and would like to learn where you got this from or just what the theme is named. Cheers!
Having read this I believed it was rather enlightening. I appreciate you spending some time and effort to put this short article together. I once again find myself spending way too much time both reading and posting comments. But so what, it was still worth it.
Hi, I do believe this is a great web site. I stumbledupon it 😉 I will revisit yet again since i have bookmarked it. Money and freedom is the best way to change, may you be rich and continue to help others.
Can I just say what a relief to discover somebody that truly knows what they are talking about on the web. You definitely know how to bring an issue to light and make it important. More and more people really need to check this out and understand this side of the story. It’s surprising you’re not more popular since you surely have the gift.
May I just say what a comfort to uncover someone who genuinely knows what they’re talking about on the net. You definitely realize how to bring a problem to light and make it important. A lot more people ought to look at this and understand this side of the story. I was surprised you aren’t more popular given that you most certainly have the gift.
After I originally left a comment I seem to have clicked on the -Notify me when new comments are added- checkbox and from now on every time a comment is added I recieve four emails with the exact same comment. Is there an easy method you are able to remove me from that service? Many thanks.
I blog quite often and I truly thank you for your content. This great article has truly peaked my interest. I am going to book mark your site and keep checking for new information about once a week. I subscribed to your Feed as well.
Everyone loves it whenever people get together and share ideas. Great site, keep it up.
Good post. I am dealing with some of these issues as well..
I couldn’t refrain from commenting. Well written.
This web site really has all of the info I needed concerning this subject and didn’t know who to ask.