MINISTRY OF HEALTH AND FAMILY WELFARE RELEASES DRAFT GUIDELINES FOR MEDICAL DIAGNOSTIC LABORATORIES IN THE COUNTRY

May 9, 2017 by · Leave a Comment
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MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION – New Delhi, the 5th May, 2017

Central Govt proposes to introduce new rules called the Clinical Establishments (Central Government) Amendment Rules, 2017 by defining Minimum Standards for diagnosis or treatment of diseases. These rules are drafted by the Govt after consultation with the National Council for Clinical Establishments in the country.

Every clinical establishment relating to diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Rules.

Draft rules clearly defined the following :

- classification of laboratories based on their size;

- infrastructure specification for these labs;

- Scope of services that can be offered by these labs;

- mandatory human resource requirements for these labs,

- Minimum requirements on usage of equipments, instruments, consumables in labs

- Legal and Statutory compliances

- Record Keeping Guidelines

- basic systems and processes that should be followed by these labs in the country to be eligible    for licensing and registration of the labs.

Above guidelines are released by MoH as draft guidelines on May 5, 2017 and same are open for public comments.

Objections and suggestions, if any, on the above guidelines may be addressed to

The Under Secretary (Medical Services),

Ministry of Health and Family Welfare,

Government of India,

Room No. 508, D Wing, Nirman Bhavan, New Delhi – 110011

or send email to sunil.kumar20@gov.in

Draft guidelines are published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

Click here for the full announcement :

Minimum Standards for Medical Labs – Clinical Establishments Act

Training Programs for the month of April 2017

April 11, 2017 by · Leave a Comment
Filed under: Uncategorized 

Team Value Added is conducting the following Training programs in April 2017.

 

Training Program on New Medical Devices Rules 2017 on  April 20, 2017, between 10 am to  1 pm @ Andhra Chamber of Commerce, “Velagapudi Ramakrishna Building”, 23 Third Cross Street, West CIT Nagar, Nandanam, Chennai – 600 035

Training is conducted by Dr.G.S.Bhuvaneshwar who has got more than 3 decades of experience in Medical Devices Design, Development, Testing and Quality Management

Training focus will be on the

  1. Current Regulations & Systems in Medical Devices
  2. Overview of the New Medical Devices Rules 2017
  3. Applicable regulations for Manufacturers, Dealers, Distributors, Importers etc

Please click here for Training brochure

Please click here for Registration form

 

NABL 112 – Specific Criteria on Accreditation of Medical Laboratories – April 22nd 2017 between 9.30 am to 1 pm @ Andhra Chamber of Commerce, “Velagapudi Ramakrishna Building”, 23 Third Cross Street, West CIT Nagar, Nandanam, Chennai – 600 035

 

NABL has revised the specific criteria document recently based on ISO 15189:2012 standard requirements. The new document comes into effect from 1st July 2017.

This new NABL 112 document supersedes the NABL 112 3rd Issue. All Medical Laboratories either applying for accreditation from now on or NABL applicant laboratories & laboratories awaiting surveillance or recertification assessment are to conform to this new NABL 112 document requirements

A sensitization & Awareness session on the recently released NABL 112 – specific criteria on Accreditation of Medical Laboratories by Dr.V.K.Ramadesikan

Please click here for Training brochure

Please click here for Registration form

 

Please go through the Training brochures and send us your nominations to padma@valueadded.in or info@valueadded.in.

Call us @ 24462337 / 24462338 to confirm your participation in the above training programs.

CII Health, TN & Star Health Initiative on Health Insurance Awareness Campaign at Chennai on Feb 24th 2017

February 22, 2017 by · Leave a Comment
Filed under: Announcements, Health Insurance, Healthcare, Hospital 

CII, Tamil Nadu has formed a Tamil Nadu Healthcare Panel under the convenorship of Dr. S. Prakash, Senior Executive Director, Star Health along with Dr Rohini Sridhar, COO, Apollo Hospitals Limited as co-convener.

Panel has decided to organise forum meetings across Tamil Nadu. The forum shall address issues with the major players in the Healthcare Industry, namely, Hospitals, Customers, TPAs, Pharmaceutical companies and Insurers.

We have used this panel as a platform to address the growing trust deficit in the healthcare system and have successfully conducted 3 programs so far.

The 4th forum meeting is scheduled to happen on the 24th February 2017 on promoting Best Practices in Health Insurance to Hospital front desk personnel.

This session is part of Health Insurance Education Series to Hospital Front Office Desks, Insurance Desk Teams.

Interested Teams from Hospitals can send formal confirmation mail to the contact person’s details mentioned in the poster….There is no participation fee.

CII Star Health Insurance Mailer

Workshop on GCLP (Good Clinical Laboratory Practices) on International Standards (ISO 15189:2012) @ Chennai

February 9, 2017 by · Leave a Comment
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YRG Centre for AIDS Research and Education (YRG CARE), Chennai & Sri Ramachandra University, Chennai is organizing a workshop on GCLP (Good Clinical Laboratory Practices)  on International Standards  (ISO 15189:2012) @ Chennai.

Program Details are given below:

Organized by: YRG Centre for AIDS Research and Education (YRG CARE), Chennai & Sri Ramachandra University, Chennai

Dates: 23-25, March 2017

Venue: Harvard Auditorium, Sri Ramachandra University, Chennai

Download Brochure and Registration form HERE

Contact Info: Email: gclp@yrgcare.org

UNION BUDGET 2017 – TAKE AWAYS FOR HEALTHCARE INDUSTRY

February 3, 2017 by · Leave a Comment
Filed under: Announcements, Healthcare 

Union Budget 2017 has included Healthcare as one of the 10 themes announced by Finance Minister.

Specific announcements were made for healthcare sector covering both industry players and users / beneficiaries..

Industry had mixed responses on the budget announcements…

Team Value Added has prepared a quick pointer from both industry as well as consumers persepective, on various announcements made by FM.

Click on the link below to know more about the announcements made to healthcare sector. Healthcare Industry players response to the budget announcements  was captured here.

BUDGET 2017 – WHAT IT MEANS TO HEALTHCARE INDUSTRY

Click on the link below to know more about the announcements made to the  beneficiaries ie consumers of healthcare sector

BUDGET 2017 – WHAT IT MEANS TO CONSUMERS

In continuation of the budget announcement on Medical Devices, GoI – MoH released new rules for Medical Devices Sector. Medical Devices sector representatives welcomed the prompt move by the GoI, MoH in this direction.

 

 

 

 

FICCI – India Medical Device 2017 l February 11-13, 2017l Bangalore

January 28, 2017 by · Leave a Comment
Filed under: Events 

2nd International Exhibition & Conference on Medical Device Sector –  February 11-13, 2017 @ Bangalore

 

Dept. of Pharmaceuticals, AiMed, Ministry of Chemicals & Fertilizers, Government of India  is hosting a Medical Device Conference that’s being managed by FICCI on 11th to 13th February at Bangalore

 

The show will bring together key decision makers from the realms of industry, academia, regulators, government to gauge opportunities and estimate the potential of indigenous manufacturing for Medical Electronics & Devices in India and also create an ecosystem to enable path breaking initiatives & innovations for care provision.

 

To know more

click here for brochure

click here for invite

click here for registration form

MSME Expo – National Vendor Development program in Kakinada on January 24 – 25, 2017

January 18, 2017 by · Leave a Comment
Filed under: Events 

MSME Expo is jointly organised by MSME – Development of Institute, Ministry of MSME, Government of India and Department of Industries & Commerce. Government of Andhra Pradesh with the support of Industry / Trade Bodies in Visakhapatnam on.

Session to be held on January 24th and 25th 2017 at Kakinada.

For booking of stalls at the above exhibition, further information and registration, we request you to contact:

Shri G.V.R. Naidu, Asst. Director, MSME Development Institute,

F19 to 22,D Block, Auto Nagar, Visakhapatnam – 530 012.

Tel: 0891-2517042; Mob: 09437045079;

Email: brmsmedivizag@gmail.com/ brdcdi-vish@dcmsme@gov.in;

Web: www.msmehyd.ap.nic.in.

 

DOWNLOAD BROCHURE HERE 

 

 

 

Pongal Greetings !

January 13, 2017 by · Leave a Comment
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BIO ASIA 2017 @ HYDERABAD

January 13, 2017 by · Leave a Comment
Filed under: Healthcare, Medical Devices 

Dear AiMeD Members,

Greetings!!!

It is our pleasure to inform you regarding the 14th BioAsia being organized by the Government of Telangana in partnership with the Government of India and with support from AiMeD. This event will take place from February 6-8, 2017 at Hyderabad International Convention Center.

In light of the partnership with AiMeD, our Members will be entitled to a special discount of 50% on the registration fee (MOU enclosed).

The event will serve as a networking platform for about 1500 industry leaders, corporates, healthcare & medical professionals from over 50 countries. The event will feature about 50 start-ups with extraordinary promise to transform the life sciences and healthcare sectors.

BioAsia 2017 will feature a focused conference and CME on Automation in Diagnostics on February 7th and will bring together PoC users, regulators, diagnostic companies and suppliers to also discuss future of rapid testing, automation challenges, quality control, legislation, diagnostics, and the future of PoCT going forward. More information is available at www.2017.bioasia.in

The likes of Dr. Paul Stoffels (J&J Worldwide Chairman of Pharmaceuticals & CSO), Dr. Patrick Vallance (President Worldwide R&D, GSK), Mr. Narayan Murthy (Founder, Infosys), Nobel Laureate Prof. Kurt Wuthrich (Scripps Institute), among others have already confirmed their participation.

Given the participation of policy makers, R&D institutes and industry leaders, we would like to encourage our members to take part actively in the deliberations.

click here for the Catalouge / Brochure 
click here for the AiMed Mou
click here for the Bioasia 2017 Speakers list

Registration enquiries can be forwarded to Ms. Paridhi Gupta at paridhi@biofaba.org

Warm regards,

Rajiv Nath
Forum Coordinator
Association of Indian Medical Device Industry (AiMeD)
GL-3, Ashoka Estate,
24, Barakhamba Road,
New Delhi – 110 001
Ph. +91-129-4289000/4061151
Fax. +91-129-4061164 & 2233242
E-mail : forumcoordinator@aimedindia.com
Web : www.aimedindia.com

UDYOG AADHAAR MEMORANDUM (UAM) – MSME Registration

January 9, 2017 by · Leave a Comment
Filed under: Events & Updates, Manufacturing & Services 

Udyog Aadhaar Memorandum is an initiative of MSME Ministry Government of India, simplifying the registration procedure for Entrepreneurs and promoting ease of doing business.

As per Ministry of Micro,Small & Medium Enterprises, Government of India notification No. SO 2576 (E) date 18.09.2015, the filing of Entrepreneur Memorandum (EM) Part-I && II and issuance of Acknowledgement has been replaced by Udyog Aadhar Memorandum (UAM) and Udyog Aadhar Acknowledgement respectively.

UAM is applicable only for existing running units and not for any upcoming units.

The process of filing UAM is a simple one page document through ONLINE.

UAM shall be filed on self declaration basis and no supporting documents are required to be uploaded while filing.

No Registration fee is applicable.

Existing enterprises, which have filed Entrepreneurship Memorandum-I or Entrepreneurship Memorandum-II or both, or the holders of Small Scale Industry registration, prior to the coming into force of the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006) shall not be required to file Udyog Aadhaar Memorandum, but if they so desire, they may also file the Udyog Aadhaar Memorandum

Udyog Aadhaar Memorandum shall be filed online by MSMEs in the Udyog Aadhaar portal (http://udyogaadhaar.gov.in), maintained by the Ministry of MSME Government of India by every MSME.

Documents Required For Udyog Aadhaar MSME Registration

 

Aadhaar Number 12 digits Aadhaar number issued to the applicant.

This Aadhaar number shall be of the Managing partner in case of Proprietary Enterprise, of the Authorised Partner in case of Partnership Enterprise and of the Authorised Person in case of Other forms of Enterprises

Name of Owner The applicant name as mentioned on the Aadhaar Card issued by UIDAI
Social Category General / Scheduled Caste / Scheduled Tribe / Other Backward Castes
Name of Enterprise Name of the Legal Entity to conduct business. One applicant can have more than one enterprises doing business and each one can be registered for a separate Udyog Aadhaar and with the same Aadhaar Number
Type of Organization Type of Business entity or Legal Entity. (Proprietorship, Partnership Firm, Hindu Undivided Family, Private Limited Company, Co-Operative, Public Limited Company, Self Help Group, LLP, Others)
Postal Address Address of the business including mobile and email address
Date of Commencement The date on which businesses was started
Previous Registration Details Details of previous MSME registration, if applicable should be entered here
Bank Details Details of the bank account of the company including IFSC Code and Bank Account number
Major Activity Major area of activity of the business – manufacturing or service
NIC Code The appropriate NIC Code should be entered from the National Industrial Classification (NIC) handbook. The Applicant may choose multiple National Industrial Classification-2008 (NIC) Codes to includes all their activities. Which means user can select multiple NIC code of Manufacturing and Service sector by clicking “Add More” button
The person employed The total number of people employed in the business
Investment in Plant & Machinery / Equipment Amount of money invested in terms of machinery and equipment by the business
DIC Details of the District Industry Center nearest to the business, if required
SUBMIT The Applicant must click on Submit button to generate acknowledgment number

On submission of the form, Udyog Aadhaar Acknowledgement shall be generated and mailed to the email address provided in the Udyog Aadhaar Memorandum which shall contain unique Udyog Aadhaar Number  (UAN).

Please click here for the MSME Notification                                http://bit.ly/2iXJjEg

Please click here for the Udyog Aadhar Guide/ Booklet       http://bit.ly/2hXSzq2

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