Cisema (@cisemahk) 's Twitter Profile
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

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China released Cosmetic Challenge Test Guidelines in July to standardize safety evaluations for cosmetics. Mandatory for registration, these tests assess preservative effectiveness by monitoring microbial contamination. Read more: cisema.com/en/china-chall…

China released Cosmetic Challenge Test Guidelines in July to standardize safety evaluations for cosmetics. 

Mandatory for registration, these tests assess preservative effectiveness by monitoring microbial contamination. 

Read more: cisema.com/en/china-chall…
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China’s IVDC released 16 new veterinary disinfectant test report templates on June 24, 2024, to standardize testing and enhance registration quality. Get more detail here: cisema.com/en/china-veter… #VeterinaryDisinfectants #Regulatory

China’s IVDC released 16 new veterinary disinfectant test report templates on June 24, 2024, to standardize testing and enhance registration quality. 

Get more detail here: cisema.com/en/china-veter…

#VeterinaryDisinfectants #Regulatory
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China’s NMPA approved 134 medical devices in June 2024, maintaining 2023's average monthly trend. Highlights: 109 domestic Class III, 25 imported Class II & III. Read more: cisema.com/en/china-medic… #medtech #Regulation

China’s NMPA approved 134 medical devices in June 2024, maintaining 2023's average monthly trend. 

Highlights: 
109 domestic Class III, 
25 imported Class II & III. 

Read more: cisema.com/en/china-medic…

#medtech #Regulation
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China’s NMPA proposes revised GMPs for Excipients & Packaging Materials. Deadline for industry comment: Aug 20, 2024. Learn more: cisema.com/en/gmp-for-exc… #gmp #pharmaceuticals #excipients

China’s NMPA proposes revised GMPs for Excipients & Packaging Materials. 

Deadline for industry comment: Aug 20, 2024. 

Learn more: cisema.com/en/gmp-for-exc… 

#gmp #pharmaceuticals #excipients
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New CCC rules for e-bike chargers & lithium batteries start Oct 15, 2024. Mandatory certification for China is required from Nov 1, 2025, or face market restrictions. cisema.com/en/china-elect… #CCC #chinacertification #ebike #battery

New CCC rules for e-bike chargers & lithium batteries start Oct 15, 2024. 

Mandatory certification for China is required from Nov 1, 2025, or face market restrictions. 

cisema.com/en/china-elect…

#CCC #chinacertification #ebike #battery
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Unlock Hong Kong's healthcare potential & leap into the 80M-strong Greater Bay Area! Join our webinar next Tues to learn how others did it. Register now! @ event.webinarjam.com/register/95/no… #Healthcare #webinarseries #China #HongKong #Pharmaceuticals #MEDTECH

Unlock Hong Kong's healthcare potential & leap into the 80M-strong Greater Bay Area! 

Join our webinar next Tues to learn how others did it. 

Register now! @ event.webinarjam.com/register/95/no…

#Healthcare #webinarseries #China #HongKong #Pharmaceuticals #MEDTECH
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Daewoong Bio Inc.'s import of Cefodizime Sodium for Injection suspended by China's NMPA after failing to comply with on-site inspection. A vital compliance reminder! Read more: cisema.com/en/nmpa-inspec… #Pharmaceuticals

Daewoong Bio Inc.'s import of Cefodizime Sodium for Injection suspended by China's NMPA after failing to comply with on-site inspection. 

A vital compliance reminder! 

Read more: cisema.com/en/nmpa-inspec…

#Pharmaceuticals
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Is your medical device needed for life-threatening conditions with no alternatives in China? NMPA’s new temporary import scheme for urgent clinical need could help. Learn more: cisema.com/en/class-iii-m… #MEDTECH #Urgent #China

Is your medical device needed for life-threatening conditions with no alternatives in China? 

NMPA’s new temporary import scheme for urgent clinical need could help. 

Learn more: cisema.com/en/class-iii-m…

#MEDTECH #Urgent #China
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Benötigen Sie eine CCC-Zertifizierung, um in China zu verkaufen? Jetzt für unser kostenfreies Seminar am 10.09. anmelden! 🇨🇳📅 Mehr Infos: cisema.com/en/seminar-chi… #China #certification #regulation

Benötigen Sie eine CCC-Zertifizierung, um in China zu verkaufen? 

Jetzt für unser kostenfreies Seminar am 10.09. anmelden! 

🇨🇳📅 

Mehr Infos: cisema.com/en/seminar-chi…

#China #certification #regulation
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China's NMPA has approved 282 innovative medical devices since 2014, including Shanghai Wicresoft's stent system. Learn about fast-track, green pathway approvals and how Cisema can help you bring cutting-edge technology to China quicker: cisema.com/en/innovative-… #MedTech

China's NMPA has approved 282 innovative medical devices since 2014, including Shanghai Wicresoft's stent system. 

Learn about fast-track, green pathway approvals and how Cisema can help you bring cutting-edge technology to China quicker:
cisema.com/en/innovative-…

#MedTech
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China’s CDE has released a draft on clinical trial requirements for drugs listed overseas but not in China. Public comments are open until Sept 26, 2024. #Pharma #China #ClinicalTrials

China’s CDE has released a draft on clinical trial requirements for drugs listed overseas but not in China. 

Public comments are open until Sept 26, 2024. 

#Pharma #China #ClinicalTrials
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China’s new Compulsory Certification for gas hoses & shut-off valves starts Oct 1, 2025. Manufacturers must comply to stay competitive in the market. #GasSafety #Compliance

China’s new Compulsory Certification for gas hoses & shut-off valves starts Oct 1, 2025. 

Manufacturers must comply to stay competitive in the market. 

#GasSafety #Compliance
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Earlier this month, Jacky Li joined the InvestHK HKSAR seminar on Hong Kong's role as a medtech hub and gateway to China via the GBA. Key takeaways and insights here: lnkd.in/dBpBuiGc #MEDTECH #HongKong #Regulatory

Earlier this month, Jacky Li joined the <a href="/InvesthkH30948/">InvestHK HKSAR</a> seminar on Hong Kong's role as a medtech hub and gateway to China via the GBA. 

Key takeaways and insights here: lnkd.in/dBpBuiGc

#MEDTECH #HongKong #Regulatory
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🚨 Big news for the health food industry! Over the summer, China added 4 new substances to its Dual-Use Substances Catalogue, blending health food & traditional medicine!🌱🍃 China health food 4 new dual-use substances (cisema.com) #RegulatoryUpdate #HealthFood

🚨 Big news for the health food industry!  

Over the summer, China added 4 new substances to its Dual-Use Substances Catalogue, blending health food &amp; traditional medicine!🌱🍃 

China health food 4 new dual-use substances (cisema.com)

#RegulatoryUpdate #HealthFood
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Here is an insightful video that dives deep into how the MDACS listing can be your gateway to success in Hong Kong and the GBA. Cisema will guide you through the regulatory updates and market entry strategy. Language: Chinese youtube.com/watch?v=8xqspC… #HongKong #MedicalDevice

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China's NMPA mandates overseas drug license holders to appoint a Domestic Responsible Person by July 2025, ensuring stricter post-market drug oversight and compliance. Visit: cisema.com/en/drp-for-ove… for more info

China's NMPA mandates overseas drug license holders to appoint a Domestic Responsible Person by July 2025, ensuring stricter post-market drug oversight and compliance.
Visit: cisema.com/en/drp-for-ove… for more info
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NMPA flags 49 batches of cosmetics for non-compliance, including banned substances & mislabeling. Risk control & recalls ordered. QA must prioritize strict compliance! #cosmetics #china #Compliance cisema.com/en/china-non-c…

NMPA flags 49 batches of cosmetics for non-compliance, including banned substances &amp; mislabeling. Risk control &amp; recalls ordered. QA must prioritize strict compliance!

#cosmetics #china #Compliance 

cisema.com/en/china-non-c…
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🚨 Watch our 2024 Round-Up of China Medical Device Regulations on-demand webinar! 🚨 Insights on registration trends, GBA strategies, & 2025 compliance prep. Watch now: youtube.com/watch?v=-fEJ_q… #medicaldevice #medtech #china

🚨 Watch our 2024 Round-Up of China Medical Device Regulations on-demand webinar! 🚨

Insights on registration trends, GBA strategies, &amp; 2025 compliance prep. 

Watch now: youtube.com/watch?v=-fEJ_q…

#medicaldevice #medtech #china
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As we wrap up another remarkable year at Cisema, we want to take a moment to express our heartfelt gratitude to our incredible team, clients and partners worldwide. This festive season, we wish you and your loved ones peace, joy, and memorable moments together!

As we wrap up another remarkable year at Cisema, we want to take a moment to express our heartfelt gratitude to our incredible team, clients and partners worldwide.

This festive season, we wish you and your loved ones peace, joy, and memorable moments together!
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#Cisema is excited to announce that our team will be attending 3 major events in Jan! 1) BIO Partnering @JPM Week 2025, 13 – 16 Jan 2) 24th Annual regulanet® Conference, 22 – 24 Jan 3) Arab Health 2025, 27 – 30 Jan #JPMWeek #BioWeekSF #JPM2025 #regulanet #ArabHealth2025

#Cisema is excited to announce that our team will be attending 3 major events in Jan!

1) BIO Partnering @JPM Week 2025, 13 – 16 Jan 

2) 24th Annual regulanet® Conference, 22 – 24 Jan 

3) Arab Health 2025, 27 – 30 Jan

#JPMWeek #BioWeekSF #JPM2025 #regulanet #ArabHealth2025