Brazil

May 71 min read

Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)

On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...

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ARQon

Jun 30, 20202 min read

Brazil: UDI enforced & ANVISA RDC 356/2020 & RDC 379/2020 for Covid-19

RDC 232/2018 - Unique Device Identification (UDI) UDI will be enforced on 15 June 2020 that require product label with traceability using...

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ARQon

Dec 4, 20191 min read

Central & South America - Nov/Dec 2019

Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...

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ARQon

Aug 30, 20191 min read

Central & South America - Aug 2019

Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...

21 views0 comments

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...

25 views0 comments

ARQon

May 30, 20192 min read

Brazil Class I Medical Devices Notification

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of...

103 views0 comments

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...

21 views0 comments

ARQon

Nov 5, 20181 min read

Central & South America - Dec 2018

Brazil: Requirements drafted for custom-made and patient-specific medical devices Brazil: Procedure for handling imported medical devices...

13 views0 comments

ARQon

Sep 4, 20181 min read

Drugs - Aug/Sep 2018

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...

22 views0 comments

ARQon

Nov 1, 20172 min read

Drugs - October 2017

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...

21 views0 comments

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