Search Our News
Latest Headlines
- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
Blogs by Country
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
Asia Headquarters
116 Changi Road, #04-05
Singapore 419718
+65 8800-3197
Indian Industry Association Drafting a Uniform Code for Medical Device Marketing Practices
/in India, Latest Updates/by Gunjan VermaThe updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
India Temporarily Suspends Compulsory Medical Device Registrations
/in India, Latest Updates/by Gunjan VermaIn public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.
VietNam Expedites Registration of COVID-19 Related Medical Devices
/in Latest Updates, Vietnam/by David VoWith the release of Circular 13/2021/TT-BYT on September 16, 2021, the VietNamese Ministry of Health has provided a new, expedited review process for specified medical devices related to COVID-19.
India to Require All Medical Devices be Registered Before Importation
/in India, Latest Updates/by Gunjan VermaOn September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021.
The Philippines FDA Releases List of VAT Exempt Therapeutic Products
/in Latest Updates, Philippines/by Glend LlantadaOn September 14th, the Philippines FDA released FDA Advisory No.2021-2293, outlining the list of VAT-Exempt Products pursuant to Republic Act No. 11534, otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act.”
Asia Actual Launches Online Medical Device Approval Search Service
/in Latest Updates/by Bryan GilburgAsia Actual is excited to launch R.O.S.E., the Registration Optimized Search Engine. The goal of R.O.S.E. is to provide centralized access to medical device registration data in Asian markets.
Philippines Releases New Guidance on Class A Medical Devices
/in Latest Updates, Philippines/by Charmaine Rosonthe FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN).
Philippines Extends Grace Period for Non-Notified Class B, C, and D Medical Device Registration
/in Latest Updates, Philippines/by Charmaine RosonDuring this transition period, Class B, C, and D medical devices that are not included in the specified list in Circular No. 2021-001-A may continue to be manufactured, imported/exported, distributed, and/or sold without a CMDN until March 31, 2022.