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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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INDIA PLANS TO REGULATE ALL MEDICAL DEVICES
/in India, Latest Updates/by Bryan GilburgThe CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.
KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS
/in Latest Updates, South Korea/by Bryan GilburgAny company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to several new requirements. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
India to Regulate Surgical Drapes and Gowns
/in India, Latest Updates/by Bryan GilburgSurgical drapes and gowns have been added to the Indian list of notified medical devices. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.
PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS
/in Latest Updates, Philippines/by Bryan GilburgThe Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed. Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.
INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION
/in India, Latest Updates/by Bryan GilburgThis Notification announcement represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.
THAILAND TO REGULATE HAND SANITIZER AS A MEDICAL DEVICE
/in Latest Updates, Thailand/by Bryan GilburgPHILIPPINES NEW MEDICAL DEVICE REGULATIONS TO LAUNCH IN APRIL
/in Latest Updates, Philippines/by Glend LlantadaHONG KONG OPENS THE VOLUNTARY REGISTRATION SYSTEM TO CLASS B & C IVD DEVICES
/in Hong Kong, Latest Updates/by Bryan Gilburg