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- Key Takeaways from Vietnam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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Good Distribution Practice Requirements in Indonesia
/in Indonesia, Latest Updates/by Ilham HidayattulahIn 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.
Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
/in China, India, Japan, Latest Updates, South Korea, Taiwan, United States/by Albert PranotoAn outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
India Issues New Sales License Requirement for Medical Devices
/in India, Latest Updates/by Gunjan VermaOn September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.
Expedited Market Access Now Available in Philippines
/in Latest Updates, Philippines/by Charmaine RosonOn September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.
India Grants Import License Grace Period for Class A/B Devices
/in India, Latest Updates/by Gunjan VermaReleased on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.
India Issues Draft Notification for Exempting Certain Class A Medical Devices
/in India, Latest Updates/by Gunjan VermaThe Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.
Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR
/in Latest Updates, Philippines/by Charmaine RosonAnnounced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.
Vietnam’s DMEC Provides Update on Issuance of C/D Licenses
/in Latest Updates, Vietnam/by David VoOn September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.