by admin | Oct 20, 2016 | MtaI News
The second draft of the medical devices regulations, which were notified by the Union health ministry on Wednesday, four months after the first draft was issued, have once again drawn industry flak. The fresh rules, while dividing the medical devices into four groups...
by admin | Aug 15, 2018 | MtaI News
On Independence Day, Prime Minister Narendra Modi announced the launch of Ayushman Bharat,now Jan Aarogya Abhiyan covering 50 crore people. The mission is to give access to the country’s poor to quality and affordable healthcare. Around 10 crore families will get...
by admin | Aug 14, 2018 | MtaI News
The top medical association representing global MedTech firms has announced that it is organizing the ‘MTaI Medtekon’ on September 20, 2018 to address outstanding issues in the government’s premier healthcare flagship scheme New Delhi: The National Health...
by admin | Oct 20, 2016 | MtaI News
The Union government has notified a set of new rules to regulate the medical device sector – worth thousands of crores and growing. For the first time, the rules will make a distinction between medical devices and drugs and pharmaceuticals, creating separate standards...
by admin | Oct 20, 2016 | MtaI News
The health ministry’s medical devices rules still deviate from globally accepted practices, insisting on conditions like different labelling requirements and shorter expiry dates for the products, argue global medical device makers upset with the third draft of...
by admin | Oct 17, 2016 | Circulars & Notices
The second draft of Medical Device Rules, 2016 have been shared with the medical device industry/ associations for Objections and suggestions to be submitted to MoHFW for their consideration.
by admin | Oct 15, 2016 | MtaI News
The multinational medical technology majors are seeking the authorities to remove regulatory hurdles for importing pre-owned medical equipment to the country. While these companies manufacture in India and support the Centre’s initiatives to promote...
by admin | Oct 15, 2016 | MtaI News
The medical devices industry remains bitterly divided even as the Centre looks to regulate import of pre-owned products Away from the glare of very public discussions on stents, a device used largely in the heart, another debate engulfs the medical devices...
by admin | Oct 11, 2016 | MtaI News
The center-right government of Indian Prime Minister Narendra Modi says it has the medical devices sector squarely in its sights as one of its priority “Make in India” sectors to boost domestic manufacturing and spur job creation, and global medical device makers are...
by admin | Oct 5, 2016 | Circulars & Notices
The circular lists down the documents required to be uploaded & submitted online though the SUGAM Portal along with the necessary Form No. for Import and Registration of Medical Device & Diagnostic
by admin | Oct 5, 2016 | Circulars & Notices
Information/ data in respect of notified medical devices, manufactured/ imported/ marketed by the companies has been sought in a prescribed format. All the companies whose names are mentioned in the annexures are requested to take urgent action within 7 days of issue...
by admin | Oct 5, 2016 | MtaI News
Contemporary bare-metal stents are as good as drug-eluting stents—their newer generation counterparts—a new Norwegian study on over 9,000 patients has found. The observation comes at a time when India has decided to clamp price controls on stents and the government is...
by admin | Sep 5, 2016 | Circulars & Notices
In consultation with the stakeholders and with the concurrence of the Ministry of Health & Family Welfare (MoHFW), it has been decided that the validity period of approval of Bioavailability, Bioequivalence study centre and Bioanalytical laboratory will be...
by admin | Aug 30, 2016 | Circulars & Notices
The Drugs & Cosmetics Act has come into force to regulate the drugs & medical devices sector in India.
by admin | Aug 30, 2016 | Circulars & Notices
The Pharma/ Medical Device Associations are requested to intimate the action taken by them including the constitution of the “Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP)” urgently.
by admin | Aug 8, 2016 | Circulars & Notices
The proposed requirements for the regulatory control over notified medical devices are being uploaded for the information of all stakeholders. The document is intended to provide guidance for use in the registration of notified medical devices (excluding notified...
by admin | Aug 6, 2016 | Circulars & Notices
The Second Health Cricket Cup Tournament is scheduled to be held from September 24, 2016-October 2, 2016 at Central Secretariat Ground, VinayMarg, Chanakyapuri, New Delhi featuring six teams.
by admin | Jun 29, 2016 | Uncategorized
Text – Quality Management System – For Notified Medical Devices and In-Vitro Diagnostics
