Tag Archive for: Draft Guidance

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The 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.

China Publishes 9 Draft Guidelines for Registration of Medical Devices

Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.

Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.