Cisema(@CisemaHK) 's Twitter Profileg
Cisema

@CisemaHK

Regulatory Affairs & CRO in China for Life Sciences, Cosmetics, Health Foods, Industrial & Consumer Goods

ID:1262937137130795013

linkhttp://cisema.com calendar_today20-05-2020 02:44:23

284 Tweets

247 Followers

987 Following

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Unique Device Identifiers for certain Class II Medical Devices for China come into effect on June 1, 2024.

Are you ready?

Join us and Reed Tech for our upcoming webinar on Tuesday 23 April at 16:00CET / 10:00EST

Register: hubs.ly/Q02rm56v0

Unique Device Identifiers for certain Class II Medical Devices for China come into effect on June 1, 2024. Are you ready? Join us and @ReedTechLifeSci for our upcoming webinar on Tuesday 23 April at 16:00CET / 10:00EST Register: hubs.ly/Q02rm56v0 #china #regulatory
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Various cosmetics stability & evaluation guidelines have been released for public comment by China's National Institute for Food & Drug Control.

The deadline is 17 April 2024.

Read our article for the highlights:
cisema.com/en/china-cosme…

Various cosmetics stability & evaluation guidelines have been released for public comment by China's National Institute for Food & Drug Control. The deadline is 17 April 2024. Read our article for the highlights: cisema.com/en/china-cosme… #Cosmetics #china #regulatory
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China’s medical device sampling inspection plan 2024 is out. A total of 66 product varieties are listed.

The focus is primarily on medical electrical equipment, eg carbon dioxide laser therapy, electrocardiographs & medical pulse oximeters.

More info at lnkd.in/eD6uV3UM

China’s medical device sampling inspection plan 2024 is out. A total of 66 product varieties are listed. The focus is primarily on medical electrical equipment, eg carbon dioxide laser therapy, electrocardiographs & medical pulse oximeters. More info at lnkd.in/eD6uV3UM
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Hong Kong authorities have made 2 important announcements for medical devices:

1) A new online platform for listing medical devices in Hong Kong has been announced

2) Singapore HSA marketing approvals will now be accepted

Read our article cisema.com/en/hong-kong-m…

Hong Kong authorities have made 2 important announcements for medical devices: 1) A new online platform for listing medical devices in Hong Kong has been announced 2) Singapore HSA marketing approvals will now be accepted Read our article cisema.com/en/hong-kong-m… #regulatory
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Clinical evaluation pathways for certain have been updated by China's NMPA, notably, these include:

- surgical navigation systems
- ex vivo organ perfusion transportation devices
- implantable wires for plastic surgery.

Read our article: cisema.com/en/china-medic…

Clinical evaluation pathways for certain #medicaldevices have been updated by China's NMPA, notably, these include: - surgical navigation systems - ex vivo organ perfusion transportation devices - implantable wires for plastic surgery. Read our article: cisema.com/en/china-medic…
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China's NMPA has released 15 new toothpaste testing methods.

They've been incorporated into China’s Cosmetics Safety & Technical Standards and come into effect on 1 December 2024.

Discover the 15 tests here: cisema.com/en/china-tooth…

China's NMPA has released 15 new toothpaste testing methods. They've been incorporated into China’s Cosmetics Safety & Technical Standards and come into effect on 1 December 2024. Discover the 15 tests here: cisema.com/en/china-tooth… #cosmetics #china #regulatory #toothpaste
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China witnessed unprecedented growth in drug registration applications & approvals in 2023.

Chemical drugs remain the dominant modality, nearly 2x that of 2019.

Read our article for highlights of the NMPA's Annual Report: cisema.com/en/china-drug-…

China witnessed unprecedented growth in drug registration applications & approvals in 2023. Chemical drugs remain the dominant modality, nearly 2x that of 2019. Read our article for highlights of the NMPA's Annual Report: cisema.com/en/china-drug-… #China #pharma #regulatory
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It’s day 1 of the Association Cosmed Regulatory Conference in Paris.

Victoria Caldy from CISEMA is speaking tomorrow at 14:30 CET on the latest regulatory updates for cosmetics in China

It’s day 1 of the @AssoCosmed Regulatory Conference in Paris. Victoria Caldy from CISEMA is speaking tomorrow at 14:30 CET on the latest regulatory updates for cosmetics in China #regulatory #cosmetics #china
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China's NMPA is restarting overseas factory inspections, with recent notifications to medical device manufacturers.

Our article discusses the process and compares it to EU and US inspections.

Contact Cisema for tailored compliance advice.



cisema.com/en/nmpa-restar…

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Join our webinar tomorrow, Tuesday 26 march at 9.00am CET for essential information on

Accessing the Greater Bay Area via a Hong Kong Listing for Life Sciences companies.

Register here> event.webinarjam.com/register/93/44…

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Do you know the special pathway for importing medical devices & pharmaceuticals from Hong Kong into China's Greater Bay Area?

Join our 30-minute webinar on Tuesday 26 March 2024 at 9:00 CET/ 16:00 CST

Register now: lnkd.in/dgzymj9T

Do you know the special pathway for importing medical devices & pharmaceuticals from Hong Kong into China's Greater Bay Area? Join our 30-minute webinar on Tuesday 26 March 2024 at 9:00 CET/ 16:00 CST Register now: lnkd.in/dgzymj9T #medtech #pharmaceutical #HongKong
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Some in China are now subject to new standards. 

A total of 8 new standards came into effect on March 1, 2024; another 10 will come into effect in 2025.

cisema.com/en/china-medic…

Some #medicaldevices in China are now subject to new standards.  A total of 8 new standards came into effect on March 1, 2024; another 10 will come into effect in 2025. cisema.com/en/china-medic… #regulatory #MedTech
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China Compulsory Certification (CCC) is now being delivered in electronic format.

Other changes include new content and style for the CCC certificate, and automobiles & motorcycles have a special identification with additional letters “DC”

cisema.com/en/china-compu…

China Compulsory Certification (CCC) is now being delivered in electronic format. Other changes include new content and style for the CCC certificate, and automobiles & motorcycles have a special identification with additional letters “DC” cisema.com/en/china-compu… #regulatory
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Over 2700 new medical devices & IVDs were approved by China's NMPA in 2023.

Will you be joining them in the world's 2nd largest healthcare market?

Get the highlights of the NMPA's annual report on our blog: cisema.com/en/china-medic…

Over 2700 new medical devices & IVDs were approved by China's NMPA in 2023. Will you be joining them in the world's 2nd largest healthcare market? Get the highlights of the NMPA's annual report on our blog: cisema.com/en/china-medic… #china #medtech #medicaldevices #regulatory
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Join us, the Belgian-Chinese Chamber of Commerce (BCECC) & Horsten International this Thursday 22 February @ 10.30am CET for the latest trends, regulatory hurdles & market entry strategies for Life Sciences in China

Register here: bcecc.be/life-science-r…

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Don't forget to register for our upcoming 30-minute webinar on China Registration Pathways for Medical Devices & IVDS!

It's this Thursday, February 15, 2024 @ 08.00 EST / 14.00 CET

Sign up here: event.webinarjam.com/register/91/l9…

Don't forget to register for our upcoming 30-minute webinar on China Registration Pathways for Medical Devices & IVDS! It's this Thursday, February 15, 2024 @ 08.00 EST / 14.00 CET Sign up here: event.webinarjam.com/register/91/l9… #regulatory #china #MedTech
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In-Vitro Diagnostic Reagents' Instructions for Use (IFU) guidelines have been revised and updated by China's NMPA.

These guidelines cover key aspects such as naming, packaging, testing, whilst ensuring user-friendliness & compliance.



cisema.com/en/news/page/2/

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Happy Chinese New Year of the Dragon!

The Cisema team wishes you joy and abundance,

May the dragon's spirit inspire success and innovation as you fearlessly pursue your dreams in this prosperous year!

Happy Chinese New Year of the Dragon! The Cisema team wishes you joy and abundance, May the dragon's spirit inspire success and innovation as you fearlessly pursue your dreams in this prosperous year!
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China’s Energy Label Catalogue has been updated with new requirements for various product types incl:

-Welding machines
-LED flat panel lights
-Commercial induction cookers
-AC contactors
-Display monitors

cisema.com/en/china-energ…

China’s Energy Label Catalogue has been updated with new requirements for various product types incl: -Welding machines -LED flat panel lights -Commercial induction cookers -AC contactors -Display monitors cisema.com/en/china-energ… #regulatory #China #EnergyEfficiency
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Want to know more about the various registration pathways for medical devices & IVDs in China?

Join us for a 30-minute webinar on 15 February 2024 @ 14:00-14:30 CET / 08:00-08:30 EST

Register now: event.webinarjam.com/register/91/l9…

Want to know more about the various registration pathways for medical devices & IVDs in China? Join us for a 30-minute webinar on 15 February 2024 @ 14:00-14:30 CET / 08:00-08:30 EST Register now: event.webinarjam.com/register/91/l9… #china #regulatory #medicaldevices #medtech #webinar
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