India: CDSCO Secures IMDRF Affiliate Membership
In a major step towards strengthening its medical device regulatory framework, India’s Ministry of Health and Family Welfare has...
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ARQon
Aug 131 min read
India: CDSCO Announces New Updates to Cosmetic Division Affecting the SUGAM portal (w.e.f 16 August 2024)
Effectively starting 16 August 2024 , all stakeholders are reminded to note that the number of application submissions into the...
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ARQon
Jul 302 min read
India: Requirement of Toxicity Studies for New Drugs, SNDs, and FDCs
On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity...
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ARQon
Jun 251 min read
India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)
On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...
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ARQon
Jun 41 min read
India: CDSCO Grants Extension for Import Licenses of Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) released a circular on 16 May announcing an extension for the importation of the...
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ARQon
Dec 4, 20192 min read
Asia, Africa & Middle East - Nov/Dec 2019
Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
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ARQon
Aug 30, 20191 min read
Asia, Africa & Middle East - Aug 2019
Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...
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ARQon
Aug 30, 20191 min read
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
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ARQon
Jun 28, 20191 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
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ARQon
Mar 29, 20191 min read
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
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ARQon
Mar 28, 20191 min read
e-IFU Accepted in Medical Devices (Amendment) Rules, 2019 by India
India's Ministry of Health and Family Welfare published a new gazette notification on 15 Jan 2019, regarding an amendment to the Medical...
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ARQon
Nov 5, 20181 min read
Asia, Africa & Middle East - Dec 2018
AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...
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ARQon
Nov 5, 20181 min read
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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