OMC Medical (@omc_medical) 's Twitter Profile
OMC Medical

@omc_medical

๐ŸŒ Your trusted global regulatory & compliance partner since 2020. Simplifying EU-MDR, UKCA, FDA, TGA & more for pharmaceuticals, medical devices & cosmetics

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linkhttps://omcmedical.com/ calendar_today01-07-2024 13:33:20

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The Product Information File (PIF) is a crucial document that contains key details on a productโ€™s composition, safety, efficacy, and more for regulatory approval Read More: shorturl.at/pDs7H

The Product Information File (PIF) is a crucial document that contains key details on a productโ€™s composition, safety, efficacy, and more for regulatory approval

 Read More: shorturl.at/pDs7H
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๐‘ช๐‘ฌ ๐‘ด๐’‚๐’“๐’Œ๐’Š๐’๐’ˆ ๐’—๐’” ๐‘ผ๐‘ฒ๐‘ช๐‘จ ๐‘ด๐’‚๐’“๐’Œ๐’Š๐’๐’ˆ โ€“ Whatโ€™s the Difference? ๐Ÿ’ก Know which one you need before entering the market ๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical ๐Ÿ“ข Stay Updated. Subscribe to our Regulatory Newsletter on LinkedIn: tinyurl.com/RegulatoryNewsโ€ฆ

๐‘ช๐‘ฌ ๐‘ด๐’‚๐’“๐’Œ๐’Š๐’๐’ˆ ๐’—๐’” ๐‘ผ๐‘ฒ๐‘ช๐‘จ ๐‘ด๐’‚๐’“๐’Œ๐’Š๐’๐’ˆ โ€“ Whatโ€™s the Difference?
๐Ÿ’ก Know which one you need before entering the market
๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical
๐Ÿ“ข Stay Updated. Subscribe to our Regulatory Newsletter on LinkedIn: tinyurl.com/RegulatoryNewsโ€ฆ
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๐Ÿ‘‰ Click to explore how OMC Medical helps maintain the highest quality in clinical settings across the UAE. ๐Ÿ”— Read more on our blog โ€“ shorturl.at/RJZ9B ๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical #MedicalDevicesUAE #qualityassurance #omcmedical

๐Ÿ‘‰ Click to explore how OMC Medical helps maintain the highest quality in clinical settings across the UAE.

๐Ÿ”— Read more on our blog โ€“ shorturl.at/RJZ9B

๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical

#MedicalDevicesUAE #qualityassurance #omcmedical
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๐Ÿ‡ธ๐Ÿ‡ฆ Planning to enter the Saudi medical market? Hereโ€™s what you need to know about SFDA medical device registration โ€“ your key to compliant & successful product launch in KSA ๐Ÿฉบโœ… ๐ŸŽฏ Fast-track your market access with OMC Medical ๐Ÿ‘€ Watch the reel to learn more #sfida

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๐ŸŒ OMC Medical at #CMEF2025 โ€“ Shanghai's global hub for #MedicalDevices & #HealthcareTech! ๐Ÿค 5000+ exhibitors | 150+ countries | 310K professionals ๐Ÿ“ฉ Ready to enter Chinaโ€™s medtech market? Letโ€™s connect: omcmedical.com #DigitalHealth #MedTech #RegulatoryExperts

๐ŸŒ OMC Medical at #CMEF2025 โ€“ Shanghai's global hub for #MedicalDevices & #HealthcareTech!
๐Ÿค 5000+ exhibitors | 150+ countries | 310K professionals
๐Ÿ“ฉ Ready to enter Chinaโ€™s medtech market? Letโ€™s connect: omcmedical.com
#DigitalHealth #MedTech #RegulatoryExperts
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๐Ÿ‡ช๐Ÿ‡บ ๐‘พ๐’‰๐’ ๐’Š๐’” ๐’‚๐’ ๐‘ฌ๐‘ผ ๐‘จ๐’–๐’•๐’‰๐’๐’“๐’Š๐’”๐’†๐’… ๐‘น๐’†๐’‘๐’“๐’†๐’”๐’†๐’๐’•๐’‚๐’•๐’Š๐’—๐’† (๐‘ฌ๐‘ผ๐‘จ๐‘น)? Swipe โžก๏ธ to understand why non-EU medical device manufacturers need one ๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical

๐Ÿ‡ช๐Ÿ‡บ ๐‘พ๐’‰๐’ ๐’Š๐’” ๐’‚๐’ ๐‘ฌ๐‘ผ ๐‘จ๐’–๐’•๐’‰๐’๐’“๐’Š๐’”๐’†๐’… ๐‘น๐’†๐’‘๐’“๐’†๐’”๐’†๐’๐’•๐’‚๐’•๐’Š๐’—๐’† (๐‘ฌ๐‘ผ๐‘จ๐‘น)?  Swipe โžก๏ธ to understand why non-EU medical device manufacturers need one  

๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical
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๐Ÿ“ท Discover the importance, benefits, and potential risks of medical translation in our blog ๐Ÿ“ท Read More: tinyurl.com/2s394dcn ๐Ÿ“ท Book a Consultation: tinyurl.com/BookOMCMedical #MedicalTranslation #globalhealth #pharmatranslation #ClinicalTrials #omcmedical

๐Ÿ“ท Discover the importance, benefits, and potential risks of medical translation in our  blog
๐Ÿ“ท Read More: tinyurl.com/2s394dcn

๐Ÿ“ท Book a Consultation: tinyurl.com/BookOMCMedical

#MedicalTranslation #globalhealth #pharmatranslation #ClinicalTrials  #omcmedical
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๐Ÿšจ Expanding to Saudi Arabia? Youโ€™ll need a local ๐—”๐˜‚๐˜๐—ต๐—ผ๐—ฟ๐—ถ๐˜‡๐—ฒ๐—ฑ ๐—ฅ๐—ฒ๐—ฝ๐—ฟ๐—ฒ๐˜€๐—ฒ๐—ป๐˜๐—ฎ๐˜๐—ถ๐˜ƒ๐—ฒ (๐—”๐—ฅ) to comply with SFDA regulations! ๐Ÿ‡ธ๐Ÿ‡ฆ ๐Ÿ“ˆ Expand into Saudi Arabia smoothly and confidently. ๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical #sfida #saudiarabia

๐Ÿšจ Expanding to Saudi Arabia? Youโ€™ll need a local ๐—”๐˜‚๐˜๐—ต๐—ผ๐—ฟ๐—ถ๐˜‡๐—ฒ๐—ฑ ๐—ฅ๐—ฒ๐—ฝ๐—ฟ๐—ฒ๐˜€๐—ฒ๐—ป๐˜๐—ฎ๐˜๐—ถ๐˜ƒ๐—ฒ (๐—”๐—ฅ) to comply with SFDA regulations! ๐Ÿ‡ธ๐Ÿ‡ฆ

๐Ÿ“ˆ Expand into Saudi Arabia smoothly and confidently.

๐Ÿ“… Book a Consultation: tinyurl.com/BookOMCMedical

#sfida #saudiarabia
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Clinical Study vs. Clinical Evaluation โ€“ Whatโ€™s the Real Difference? ๐Ÿค”๐Ÿ” Understanding the two is key for regulatory success in the EU & UK medical device markets. ๐Ÿ“– Dive deeper to know when & why each is required. ๐Ÿ‘‰ Read more: tinyurl.com/mra238k9 #clinicalresearch

Clinical Study vs. Clinical Evaluation โ€“ Whatโ€™s the Real Difference? ๐Ÿค”๐Ÿ”
Understanding the two is key for regulatory success in the EU & UK medical device markets.
๐Ÿ“– Dive deeper to know when & why each is required.
๐Ÿ‘‰ Read more: tinyurl.com/mra238k9

#clinicalresearch
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Understand Medical Device Grouping in Saudi Arabia โ€” what devices can be grouped and how it affects your registration. ๐ŸŽฅWatch now & simplify your compliance journey! Link - youtu.be/blgLUcAByKA #MedicalDevices #RegulatoryAffairs #SaudiArabia #SFDA #OMCMedical

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What is FDA 501(k)? ๐Ÿค” It's a premarket submission to show your medical device is substantially equivalent to one already on the market. โœ… Faster approval โœ… Essential for Class II devices #FDA #510k #MedicalDevices #RegulatoryAffairs

What is FDA 501(k)? ๐Ÿค”
It's a premarket submission to show your medical device is substantially equivalent to one already on the market.
โœ… Faster approval
โœ… Essential for Class II devices

#FDA #510k #MedicalDevices #RegulatoryAffairs
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๐Ÿšจ Planning to sell medical devices in India? CDSCO registration is a mustโ€”for both Indian & foreign manufacturers. โœ… Classification โœ… Indian Authorized Agent โœ… SUGAM Portal submission ๐Ÿ“– Learn more: omcmedical.com/cdsco-registraโ€ฆ ๐Ÿ“… Book a consult: tinyurl.com/BookOMCMedical

๐Ÿšจ Planning to sell medical devices in India?

CDSCO registration is a mustโ€”for both Indian & foreign manufacturers.
โœ… Classification
โœ… Indian Authorized Agent
โœ… SUGAM Portal submission

๐Ÿ“– Learn more: omcmedical.com/cdsco-registraโ€ฆ
๐Ÿ“… Book a consult: tinyurl.com/BookOMCMedical
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Selling medical devices in India? ๐Ÿ‡ฎ๐Ÿ‡ณ Make sure you have: โœ… Form MD-14 โœ… Device Master File โœ… ISO 13485 And more. CDSCO compliance starts with the right documents. ๐Ÿ“– Learn more: omcmedical.com/cdsco-registraโ€ฆ ๐Ÿ“ท Book a consult: tinyurl.com/BookOMCMedical #CDSCO #MedicalDevices

Selling medical devices in India? ๐Ÿ‡ฎ๐Ÿ‡ณ
Make sure you have:
โœ… Form MD-14
โœ… Device Master File
โœ… ISO 13485
And more.
CDSCO compliance starts with the right documents.

๐Ÿ“– Learn more: omcmedical.com/cdsco-registraโ€ฆ
๐Ÿ“ท Book a consult: tinyurl.com/BookOMCMedical

#CDSCO #MedicalDevices
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Expanding to India? Foreign manufacturers need an India Authorized Agent for CDSCO registration. OMC Medical is here to help! ๐Ÿ“– Learn more: omcmedical.com/cdsco-registraโ€ฆ

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Challenges with CDSCO registration in India? ๐Ÿ˜“ OMC Medical helps you tackle documentation, delays & compliance hurdles. โœ… Expert solutions for smooth market entry. ๐Ÿ”— [omcmedical.com/cdsco-registraโ€ฆ] ๐Ÿ“ท Book a consult: tinyurl.com/BookOMCMedical

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๐Ÿ“ข Post-Market Surveillance is critical in South Korea! Ensure ongoing safety + compliance with MFDS rules for medical devices. FSCA, vigilance, & PMS reports โ€” all covered. Stay compliant โ†’ [omcmedical.com/post-market-suโ€ฆ] #MFDS #MedicalDevices #PMS #Regulations

๐Ÿ“ข Post-Market Surveillance is critical in South Korea!
Ensure ongoing safety + compliance with MFDS rules for medical devices.
FSCA, vigilance, & PMS reports โ€” all covered.
Stay compliant โ†’ [omcmedical.com/post-market-suโ€ฆ]

#MFDS #MedicalDevices #PMS #Regulations
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Planning to enter the Korean medical device market? You'll need to appoint a Local Authorized Representative (Korea AR). โœ… Learn how to choose the right AR and meet MFDS requirements. ๐Ÿ‘‰ [omcmedical.com/how-to-appointโ€ฆ] #MFDS #SouthKorea #MedicalDevices #AuthorizedRepresentative

Planning to enter the Korean medical device market?
You'll need to appoint a Local Authorized Representative (Korea AR).
โœ… Learn how to choose the right AR and meet MFDS requirements.
๐Ÿ‘‰ [omcmedical.com/how-to-appointโ€ฆ]

#MFDS #SouthKorea #MedicalDevices #AuthorizedRepresentative
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South Korea ๐Ÿ‡ฐ๐Ÿ‡ท medical device registration in under 30 seconds! Classify โžก๏ธ Appoint AR โžก๏ธ Submit docs โžก๏ธ MFDS approval โœ… Reel it. Learn it. Expand your market. Read More: ๐Ÿ‘‰omcmedical.com/south-korea-meโ€ฆ #MFDS #MedicalDevice #RegulatoryAffairs #Korea #OMCMedical

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Looking to Appoint a Local Authorized Representative (AR) in South Korea! OMC Medical offers expert MFDS AR services from our Korea office. ๐Ÿ‘‰ Learn more: [omcmedical.com/how-to-appointโ€ฆ]

Looking to Appoint a Local Authorized Representative (AR) in South Korea! OMC Medical offers expert MFDS AR services from our Korea office. ๐Ÿ‘‰ Learn more: [omcmedical.com/how-to-appointโ€ฆ]
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๐Ÿ“‹ MFDS Medical Device Registration? Start with the right documentation. From device specs to clinical evidence, hereโ€™s what South Koreaโ€™s MFDS expects: โœ… Click here: [omcmedical.com/technical-docuโ€ฆ] #MedicalDevices #SouthKorea #RegulatoryCompliance #OMCMedical

๐Ÿ“‹ MFDS Medical Device Registration? Start with the right documentation.
From device specs to clinical evidence, hereโ€™s what South Koreaโ€™s MFDS expects:

โœ… Click here: [omcmedical.com/technical-docuโ€ฆ]
#MedicalDevices #SouthKorea #RegulatoryCompliance #OMCMedical