The 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.
https://www.asiaactual.com/wp-content/uploads/2019/04/shutterstock_361019279.jpg6301200Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-04-22 14:50:282019-04-22 20:16:45INDIA PLANS TO REGULATE ALL MEDICAL DEVICES
Any 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.
https://www.asiaactual.com/wp-content/uploads/2019/04/shutterstock_1096141913.jpg6271200Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-04-20 22:47:432019-05-14 17:01:46KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS
Surgical 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.
https://www.asiaactual.com/wp-content/uploads/2019/04/shutterstock_1152711494.jpg6301120Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-04-18 15:14:182019-04-18 19:36:47INDIA TO REGULATE SURGICAL DRAPES AND GOWNS
The Philippines 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. No formal guidance on the new target implementation date has […]
https://www.asiaactual.com/wp-content/uploads/2019/04/shutterstock_670122391.jpg6271200Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-04-11 15:58:192019-04-18 20:23:50PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS
This 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.
https://www.asiaactual.com/wp-content/uploads/2019/04/shutterstock_281039342.jpg6271200Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-04-07 14:58:362019-04-18 20:40:15INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION
Thai FDA announced that hand sanitizer (alcohol gel) will require registration as a medical device (reference press released number สธ 1007/ว706 dated January 17, 2019). The change is expected to take place later this year when the new medical device classification guidelines are implemented. Since 2011, hand sanitizer with alcohol content of 62.4% by weight […]
https://asiaactual.com/wp-content/uploads/2017/03/logo2.png00Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-03-07 17:43:432019-03-12 16:15:50THAILAND TO REGULATE HAND SANITIZER AS A MEDICAL DEVICE
Today the Philippines FDA provided important guidance related to the new Medical Device Regulations at a public forum held in Manila. The target date for implementation of AO 2018-0002 was announced for April 11, 2019. At that time, Class A, B, C and D medical devices will require a Certificate of Medical Device Notification (CMDN) […]
https://asiaactual.com/wp-content/uploads/2017/03/logo2.png00Bryan Gilburghttps://asiaactual.com/wp-content/uploads/2017/03/logo2.pngBryan Gilburg2019-02-22 09:00:482019-02-28 16:59:20PHILIPPINES NEW MEDICAL DEVICE REGULATIONS TO LAUNCH IN APRIL