China NMPA Updates Classification of Sodium Hyaluronate Products
On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
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On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
On October 14, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
In 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.
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
On 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.
On 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.
Released 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.