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, 2019
- 1 min
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, 2019
- 1 min
Central & South America - Aug 2019
Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...
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ARQon
- Aug 30, 2019
- 1 min
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, 2019
- 1 min
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
- May 30, 2019
- 2 min
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...
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ARQon
- Mar 29, 2019
- 1 min
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
- Nov 5, 2018
- 1 min
Central & South America - Dec 2018
Brazil: Requirements drafted for custom-made and patient-specific medical devices Brazil: Procedure for handling imported medical devices...
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ARQon
- Sep 4, 2018
- 1 min
Drugs - Aug/Sep 2018
International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...
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ARQon
- Nov 1, 2017
- 2 min
Drugs - October 2017
US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...
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