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New Drugs, Cosmetics & Medical Devices bill should align with MDR...

Download existing Acts: A high-level government committee was constituted back in September 2021 to draft the New Drugs, Cosmetics and Medical Devices Bill which will...

Classifications of Medical Devices under the provisions of MDR 2017

Download Classifications of Medical Devices Download Classifications of Medical Devices: Safety, quality and performance of medical devices are...

Quality Medical Devices with low manufacturing cost a challenge

Medical devices development can gain traction only with innovation and research. But maintaining and sustaining quality while keeping the manufacturing costs down...

All Legislation of India (for Pharma and Health professionals)

Download All latest Legislation of India (for Pharma and Health professionals) Download latest legislation of India: Govt. of...

CDSCO to remove 8 redundant compliances related to D&C Rules, MD...

To reduce and rationalize compliance burden for improving cost and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will...

Govt to amend MDR 2017 to include UK in list of...

The Union health ministry will soon amend sub rule (3) of Rule 36 of Medical Device Rules (MDR)-2017 to include United Kingdom...

Govt to amend Rule 87 of Medical Devices Rule 2017

The Union health ministry will soon amend provisions of sale of notified medical devices as per Medical Device Rules (MDR)-2017 to effectively...

New Regulatory Regime for 8 Medical Devices under D&C Act

Adopting a proactive and sensitive approach to address the needs of the Indian Industry, the Union Ministry of Health & Family Welfare...

Safe Medical Devices: 1,257 reports evaluated through reporting tools at IPC

The Materiovigilance Programme of India (MvPI) has in total received and evaluated 1,257 Medical Devices Adverse Events (MDAE) reports till date through...

DCGI extends deadline to submit documents for Import & Regn. of...

As the situation arising out of the C-19 pandemic is worsening further in the country, the Drugs Controller General of India (DCGI)...

DCGI’s Directions for HIV kit Mfrs on kit inserts

In a bid to avoid unnecessary delay of evaluation, the Drugs Controller General of India (DCGI) has directed all the manufacturers and...

IPC to host International webinar on safety of Medical Devices

In order to create awareness on safe use of ocular devices, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Co-ordination...

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Pressure Monitoring Devices Picture: Pixabay Q 1: Whether Blood Pressure...

Drugs & Cosmetics Act should be renamed as MMDTC Act, 2021

The taskforce constituted by Patient Safety & Access Initiative of India Foundation (PSAIF) now sees the need for a major transformation on...

Govt issues draft notification to include ASTM for Medical Devices

The Union health ministry has issued draft notification vide No. GSR 98 (E) dt 05-02-2021 on Medical Devices Amendment Rules, 2021 to...

Pharma marketing: Govt soon to share draft Uniform Code

Even as the Department of Pharmaceuticals (DoP) has been seeking compliance reports from industry regarding implementation of the Uniform Code of Pharmaceutical...

6 month extension for licenses for 4 notified medical devices

The medical device industry has welcomed the Centre’s move to notify additional 6 months timeline for getting licenses for 4 notified medical...

License required to import, manufacture medical devices

New Delhi: Importers and manufacturers required to take licence from the Central Licensing Authority or State Licensing Authority for the import and manufacture of...

DCGI: Deadline extended – Import and Regn of cosmetics

The Drugs Controller General of India (DCGI) has further extended deadline by 4 months or till normalization of C-19 scenario to submit...

Govt to amend MDR-2017: Import of medical devices

The Union health ministry will soon amend Medical Device Rules (MDR)-2017 to include the provision for allowing the import of medical devices...

Medical Device: Centre to amend MDR 2017 to include ASTM

Centre is planning to amend Medical Device Rules (MDR-2017) to include American Standard Test Method (ASTM) in product standards for medical devices...

DoP: Revised guidelines for procurement of medical devices

The Department of Pharmaceuticals (DoP) has issued revised guidelines for implementing the provisions of public procurement (preference to Make in India) Order...

AiMeD to NPPA: Reduce prices of melt blown face masks

The Association of Indian Medical Device Industry (AiMeD) has sought National Pharmaceutical Pricing Authority (NPPA)’s intervention to exercise its powers under the...

1,34,298 applications related to drugs & medical devices approved: CDSCO

The Central Drugs Standard Control Organisation (CDSCO)’s Sugam portal has approved 1,34,298 out of the total 1,51,724 applications during the lockdown period...

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From makeup to shampoo: Widely-used chemical linked to 1 lakh deaths...

The research, which was carried out by New York University's Grossman School of Medicine and includes some 5,000 adults aged 55 to...

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