HIV Testing and Counselling Training

Online HIV Testing and Counselling Training (HTCT) Certification Program – 6th & 7th (Tuesday and Wednesday) December 2022 (1.00 PM to 5.00 PM)

ABOUT THE COURSE DETAILS
As per the World Health Organization (WHO) Geneva, HIV testing and counselling is a package service intended to allow people to make informed decisions regarding knowledge of their HIV status and the implications of those decisions. HIV testing and counselling helps people to cope with their HIV sero-status, make informed choices about their future practices and modify risk behaviours. Importantly, it is a gateway to prevention, care, treatment and support.

As per the National AIDS Control Organization (NACO), Government of India, New Delhi the health care settings should offer a service to protect an individual and their families by practicing the “5 Cs – Consent, Confidentiality, Counselling, Correct test results and Connection)”. This is also implemented through the standards and guidelines of the National Accreditation Board for Testing and Calibration Laboratories (NABL) and National Accreditation Board for Hospitals & Healthcare Providers (NABH) in public and private health care settings.

Program Organiser :
SDC, Saveetha University, Chennai (https://www.saveetha.com) is a not-for-profit private organization recognized by the DSIR, conducts this training program on HIV test counselling as part of its social commitment and educational services. This HIV Testing and Counselling Training (HTCT) program consists of 5 core components:
1. Pre-test counselling that outlines the testing process
2. A risk-behaviour assessment
3. Informed consent of each participant
4.Administration of the HIV test
5. Post-test counselling based on the test result(s). This course is based on the NACO guidelines.

The next session of a 2-day Online HIV Testing and Counselling Training (HTCT) Certification Program will be held on 6th & 7th (Tuesday and Wednesday) December 2022 (1.00 PM to 5.00 PM).

This HTCT program is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are accredited to be accredited by the NABL (ISO 15189: 2012) or NABH.

This certification program provides training as per the NABL-112 document and NACO guidelines, occupational post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing

Lectures, case studies and interactive sessions. Professionals including laboratory experts, clinicians, scientists with years of HIV/AIDS training experience will facilitate the program.

The participants can enrol for the program by paying Rs. 1,500/- per person and the payment can be done using net-banking or from GooglePay account to the following bank account:

Account No. 1248135000009037,
Account Name: SDC Microbiology CME,
Bank: Karur Vysya Bank,
IFSC Code: KVBL0001248,
Branch: PH Road,
Chennai600077 or scanning the QR Code as shown in the program brochure

Please refer to the attached brochure for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7

About academic partnering institutions:
Ashakirana Hospital, Centre for AIDS Care and Research, Mysuru (https://www.ashakirana.org) is a not-for-profit private organization recognized by the DSIR and providing out-patient and in-patient services as HIV speciality tertiary care centre.
Adolescent Health Foundation of India, Chennai (https://www.ahfi.in) is a not-for-profit private organization working on adolescent health, sexuality and related infections.

About Course Coordinator:
Dr. Pachamuthu Balakrishnan (http://micro.sdc.saveetha.com/faculty) has more than 25 years of experience in the field of HIV research and diagnostics. He was trained at the HIV Branch, Centre for Disease
Control and Prevention (CDC), Atlanta, USA and, also contributed to the international (World Health Organization, WHO) and national (National AIDS Control Organization, NACO) guidelines as an expert, which are accessible online.

For queries, please contact via email:
Dr. Pachamuthu Balakrishnan
HTCTSAVEETHA@gmail.com
Mobile: +91 7667444221

Download the program brochure from here

Pathcon & Lab Expo 2022

6th Annual Conference of the Association of Practising Pathologists, India
(PATHCON & Lab Expo 2022)

Pleasure to invite you all to “6th Annual Conference of the Association of Practising Pathologists, India (PATHCON & Lab Expo 2022), which is going to be held virtually on 17th (Saturday) December 2022 &  in Hybrid mode at The Hotel Vivanta by Taj, Dwarka, New Delhi on 18th (Sunday) December 2022. This conference will bring together all of us who have put in a lifetime of effort to bring this association to this landmark event.

Date: 17th (Saturday) December 2022Virtual Mode
Date: 18th (Sunday) December 2022Hybrid Mode

Participants will learn of the rapid development and spread of technical advancement in recent years, the people who made this possible and the necessary equipment, regulations and other requirements for setting up new centres. The scientific program will cover the latest developments in all disciplines of Lab medicine. The emphasis will be on interactive sessions and panel discussions with clinical colleagues to encourage active participation of all delegates. We hope the students and residents will benefit from the experience of their colleagues and teachers and gather encouragement from the pioneers in research. Several well renowned speakers have confirmed their active participation, and this will add to the academic benefits of this conference. Save the dates in your diary today. We look forward to greeting you in what promises to be an exciting and fruitful meeting with a high scientific standard.

Keeping in mind the interest of our young participants, we shall be inviting posters and abstracts for oral presentation from all across the country and details are available on the website.

This year the venue which we have finalised is situated in Dwarka, New Delhi which is well connected all across Delhi & NCR through Delhi metro and other modes of transportation. It is just 3.5 Kms away from the IGI Airport. Delhi has a wide choice of hotel accommodation for different budgets. Kindly make your arrangements for travel and stay well in advance. The weather in Delhi in December is cool and pleasant, though light jackets may be required in the evenings. The organising committee welcomes all delegates to avail the discounted early registration rates and actively participate in this landmark event in the history of our Association.

Delhi is a historical city & always been a centre of power with many monument, multiple cuisine restaurants & it is a shoppers’ paradise and very well connected by road, rail and air to all major cities of India.

Conference Registration Fee mentioned below in Brochure Please check

ABSTRACT SUBMISSION GUIDELINES

> Abstracts for Oral Presentation/Poster Presentation are to be submitted online through the conference website only.
> You need to register yourself on the online portal for submission of the abstract. You can make the registration payment later, but submission of relevant information is must.
> The presenting author MUST be registered for the conference.
> The number of papers to be accommodated are limited. You can indicate your preference during submission (oral/poster). Some abstract requests for Oral presentations will be shifted to the poster section. Case reports, unless carrying a very novel message, will not be considered for oral presentations.
> It is mandatory that the Presenting author is registered for the conference to be eligible for presentation and for awards.
> The cut-off date will be 31 Oct 2022 by 1700 hrs. No abstracts will be considered after this Deadline.
> Abstracts will be listed on the conference website by 10 Nov 2022. The abstract is restricted to a maximum of 300 words. It should include: Objectives, Methods, Results, Conclusions, and Keywords.
> One participant may submit upto 3 abstracts, and only one abstract would be considered for Oral Presentation.

Conference Manager

Mr. Saurabh Sharma
Phone: +91 9871799136
Email: secretariat.pathcon@gmail.com

Conference Secretariat
Tripti : +91 – 9958697309
Dr Neeraj Jain : +91 – 9810492621
Dr Rajan Verma : +91 – 9999138158

IPC National Conference

National conference on Strengthening Medical Product Safety Surveillance

IPC in association with Ruby Hall Clinic, Pune is organizing a national conference on “Strengthening Medical Product Safety Surveillance” on November 12, 2022 at Sheraton Grand Hotel, Bund Garden Road, Pune- 411001

For more Information Please Check Here: https://bit.ly/3fvDobv

Source:https://www.ipc.gov.in/news-highlights/1048-ipc-in-association-with-ruby-hall-clinic,-pune-is-organizing-a-national-conference-on-%E2%80%9Cstrengthening-medical-product-safety-surveillance%E2%80%9D-on-november-12,-2022-at-sheraton-grand-hotel,-bund-garden-road,-pune-411001.html

MSME Notification

Notification issued for MSME enterprises

Notification issued for MSME enterprises to continue to avail of all non-tax benefits of the category it was in before the re-classification, for a period of three years from the date of such upward change

The Ministry of MSME vide S.O. 4926 (E) dated 18.10.2022 has notified that in case of an upward change in terms of investment in plant and machinery or equipment or turnover or both, and consequent re-classification, an enterprise shall continue to avail of all non-tax benefits of the category it was in before the re-classification, for a period of three years from the date of such upward change.

This decision has been taken after due deliberations with MSME stakeholders and is in line with the Aatma Nirbhar Bharat Abhiyan. The Ministry of MSME, Government of India, has allowed those registered MSMEs to continue to avail of non-tax benefits for three years, instead of one year, in case of an upward graduation in their category and consequent reclassification.

Non-tax benefits include benefits of various schemes of the Government, including Public Procurement Policy, Delayed Payments, etc.

Download the notification from here:

Classification of MSME Enterprises

Criteria for classifying the enterprises as Micro, Small and Medium Enterprises with effect from the 1st day of July, 2020:

(i) a micro enterprise, where the investment in plant and machinery or equipment does not exceed one crore rupees and turnover does not exceed five crore rupees;

(ii) a small enterprise, where the investment in plant and machinery or equipment does not exceed ten crore rupees and turnover does not exceed fifty crore rupees; and

(iii) a medium enterprise, where the investment in plant and machinery or equipment does not exceed fifty crore rupees and turnover does not exceed two hundred and fifty crore rupees.

Composite criteria of investment and turnover for classification.–

(1) A composite criterion of investment and turnover shall apply for classification of an enterprise as micro, small or medium.

(2) If an enterprise crosses the ceiling limits specified for its present category in either of the two criteria of investment or turnover, it will cease to exist in that category and be placed in the next higher category but no enterprise shall be placed in the lower category unless it goes below the ceiling limits specified for its present category in both the criteria of investment as well as turnover.

(3) All units with Goods and Services Tax Identification Number (GSTIN) listed against the same Permanent Account Number (PAN) shall be collectively treated as one enterprise and the turnover and investment figures for all of such entities shall be seen together and only the aggregate values will be considered for deciding the category as micro, small or medium enterprise.

Composite criteria of investment and turnover for classification

  1. A composite criterion of investment and turnover shall apply for classification of an enterprise as micro, small or medium.
  2. If an enterprise crosses the ceiling limits specified for its present category in either of the two criteria of investment or turnover, it will cease to exist in that category and be placed in the next higher category but no enterprise shall be placed in the lower category unless it goes below the ceiling limits specified for its present category in both the criteria of investment as well as turnover.
  3. All units with Goods and Services Tax Identification Number (GSTIN) listed against the same Permanent Account Number (PAN) shall be collectively treated as one enterprise and the turnover and investment figures for all of such entities shall be seen together and only the aggregate values will be considered for deciding the category as micro, small or medium enterprise.

Calculation of investment in plant and machinery or equipment

  1. The calculation of investment in plant and machinery or equipment will be linked to the Income Tax Return (ITR) of the previous years filed under the Income Tax Act, 1961.
  2. In case of a new enterprise, where no prior ITR is available, the investment will be based on self-declaration of the promoter of the enterprise and such relaxation shall end after the 31st March of the financial year in which it files its first ITR.
  3. The expression ‘’plant and machinery or equipment’’ of the enterprise, shall have the same meaning as assigned to the plant and machinery in the Income Tax Rules, 1962 framed under the Income Tax Act, 1961 and shall include all tangible assets (other than land and building, furniture and fittings).
  4. The purchase (invoice) value of a plant and machinery or equipment, whether purchased first hand or second hand, shall be taken into account excluding Goods and Services Tax (GST), on self-disclosure basis, if the enterprise is a new one without any ITR.
  5. The cost of certain items specified in the Explanation I to sub-section (1) of section 7 of the Act shall be excluded from the calculation of the amount of investment in plant and machinery.

Calculation of Turnover

  • Exports of goods or services or both, shall be excluded while calculating the turnover of any enterprise whether micro, small or medium, for the purposes of classification.
  • Information as regards turnover and exports turnover for an enterprise shall be linked to the Income Tax Act or the Central Goods and Services Act (CGST Act) and the GSTIN.
  • The turnover related figures of such enterprise which do not have PAN will be considered on self-declaration basis for a period up to 31st March, 2021 and thereafter, PAN and GSTIN shall be mandatory.

    In case of an upward change in terms of investment in plant and machinery or equipment or turnover or both, and consequent re-classification, an enterprise will maintain its prevailing status till expiry of one year from the close of the year of registration.

    In case of reverse-graduation of an enterprise, whether as a result of re-classification or due to actual changes in investment in plant and machinery or equipment or turnover or both, and whether the enterprise is registered under the Act or not, the enterprise will continue in its present category till the closure of the financial year and it will be given the benefit of the changed status only with effect from 1st April of the financial year following the year in which such change took place. Other aspects relating to registration of enterprises, grievance redressal, etc. are mentioned in the Gazette Notification S.O. 2119 (E) dated June 26, 2020.

Source : IBC Laws – Classification of MSME Enterprises under the Micro, Small and Medium Enterprises Development (MSMED) Act, 2006 – N. No. S.O. 2119(E) dated 26.06.2020- amended up to date

https://pib.gov.in/PressReleasePage.aspxPRID=1869091#:~:text=2022%20has%20notified%20that%20in,of%20three%20years%20from%20the

https://www.rbi.org.in/Scripts/NotificationUser.aspx?Id=11934&Mode=0

After 14 years since the MSME Development Act came into existence in 2006, a revision in MSME definition was announced in the Atmanirbhar Bharat package in May 2020

Eat Right Campus Certification Program

Eat Right Campus Certification Program from Andhra Chamber of Commerce –
Nov 3rd 2022 – 10 am – 1 pm

Program Announcement from Andhra Chamber of Commerce
Training Session on Eat Right Campus Certification

Greetings from Andhra Chamber of Commerce!

We have the pleasure of inviting you to the Program on “Eat Right Campus Certification “@ Chamber’s conference Hall, Chennai on the 03rd November 2022 (Thursday) from 10 am to 1 pm.

Mr Prem Kumar, Principal Consultant & MD, Jayvin Management Systems & Solutions P Ltd will be the Faculty for the Training Program and Ms Rama Venugopal , the Chairman of the Quality Systems & Productivity Sub Committee of the Chamber will be the session coordinator.

We are pleased to attach herewith the soft copy of the brochure for the Program, and the draft programme schedule, for your information.

Please register through https://Registration form to participate.

Participation Fee (Inclusive of Lunch, Refreshments & Course Kit)

For Members : Rs .600/- (Inclusive of taxes) per person
Non Members : Rs.750/- (Inclusive of taxes) per person

Delegates will be issued a Certificate of Participation .

Payment Instructions :

Mode of Payment : NEFT / DD / Cheque / GPAY – 9940267991

NEFT Payment Details :
Andhra Chamber of Commerce
Name of the bank : Indian Bank
Branch & Address : South Usman Road Branch, T. Nagar, Chennai – 600 017
Current Account Number : 701020952
IFSC Code Number : IDIB000T115

Program Brochure

Contact :

Chennai Office
ANDHRA CHAMBER OF COMMERCE
“Velagapudi Ramakrishna Bldg”,
New No.23, 3rd Cross Street, West CIT Nagar P.B.No.3368,
Nandanam, Chennai – 600 035.
Telephone: Office: 24315277

Secretary General : R.Vijayalakshmi
Tel : (Per)24315278 Fax : 24315279

Email – andhrachamber1@gmail.com

acc@andhrachamber.com

HTCT Certification Program

HIV Testing and Counselling Training (HTCT) Certification program

The forthcoming session of a 2-day online HIV Testing and Counselling Training (HTCT) Certification program will be on 15th & 16th (Tuesday and Wednesday) November 2022, this virtual program is conducted between 1.00 PM to 5.00 PM on these 2 days.

This HIV test counselling training certification program (HTCT) is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are NABL (ISO 15189: 2012) / NABH accredited or under preparation for accreditation. This certification program provides training as per the NABL-112 document and NACO guidelines, occupational exposure & post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing.

Please refer to the attached brochure below for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7 (this online form needs to be filled in after making the payment)

For queries,
please contact via email: HTCTSAVEETHA@gmail.com / mobile: 7448444221.

World Standards Day 2022 Program

Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm

Sustainable Trade Development and Voluntary Sustainable Standards

Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.

The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.

Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.

Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.

Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of  environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.

Sustainability standards can unlock new markets for developing countries.

Go Green, Go Sustainable

More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.

Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.

Program Objective

Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.

The program is designed on the topic Sustainability Standards based on the WSD Theme.

Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.

Program Details

Topic – Role of Sustainability Standards in International Trade

Date : October 14th 2022 – Friday

Time : 04 30 pm – 06 00 pm

Meeting Mode – Online / Virtual

Meeting Platform – Zoom

Fee : No Registration Fee.

Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.

Registration Link

Click the button below for registration

Upon registration, registered delegates will receive meeting link.

Contact

For enquiries, pls email to

contact@ccc-consultants.org

secretariat@ccc-consultants.org

New CSR Disclosure Rules

MCA Limiting Information sharing in Annual Reports of CSR

The Ministry of Corporate Affairs (MCA) has limited details that companies must give about their Corporate Social Responsibility (CSR) projects in their annual reports.

The Companies (Corporate Social Responsibility Policy) Amendment Rules, 2022, issued on September 20, has revised Annexure II – the format in which CSR activities are disclosed in the Annual Report.

Companies can now limit the information disclosed by them on CSR spending in their annual reports. The revised Annexure II excludes details concerning the companies’ expenditure towards ongoing and other CSR projects.

The details omitted include the name, the location and duration of the company’s CSR project, the amount allocated for the project, the amount spent in the current financial year on the project, mode of implementation, the name of the implementing agency along with their CSR registration number and amount transferred to the unspent CSR account.

But these omitted details must still be disclosed by the company while filing their CSR-2 form with MCA

Source: https://economictimes.indiatimes.com/news/company/corporate-trends/new-csr-disclosure-rules-let-companies-omit-key-details/articleshow/94690487.cms

CDSCO Notification on Resellers

Registration by Medical Device Distributors, Stockists, Exhibitors or Resellers made a must under Medical Device Regulations

Ministry of Health and Family Welfare (MoHFW) has asked Distributors, traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country.

In a notification dated September 30 2022, the Union Ministry of Health and Family Welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need to obtain a Certificate of Registration. These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022.

These rules shall come into force on the date of their publication in the Official Gazette.

Key points from the Notification released :

In the said rules, after rule 87, the following rules shall be inserted, namely:—

“87A. Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1) The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas as may be specified.

(2) Any person who intends to sell, stock, exhibit or offer for sale or distribute a  medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution.

(3) The application made under sub-rule (2) shall be accompanied with

  • a fees specified in Second Schedule;
  • self certificate of compliance with respect to Good Distribution Compliance;
  • details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card;
  • documentary evidence in respect of ownership or occupancy on rental of the premises;
  • details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:—
    • hold a degree from a recognized University/Institution; or
    • is a registered pharmacist; or
    • has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with sale of medical devices;
  • brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and
  • an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.

(4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate in Form MD42, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days from the date the application is made under sub-rule (2).

(5) If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such appeal.

87B. Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1)The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.

(2) The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.

(3) The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.

(4) The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity.

(5) Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained. 

(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing.

(7) All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.

(8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.

87C. Validity of registration certificate.— (1)A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority:

Provided that, if the registration certificate holder fails to pay the required registration certificate retention fee on or before due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within six months:

Provided further that in the event of non-payment of such fee within the period referred to in the first proviso, the registration certificate shall be deemed to have been cancelled.

87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause as to why such an order should not be passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the registration certificate.

(2) A registration certificate holder whose registration certificate has been suspended or cancelled by the State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government and the State Government, shall after giving the registration holder an opportunity of being heard, confirm, reverse or modify such order, with reasons to be recorded in writing.”.

Notification also contains other information like application format (MD 41), MD 42, fee details etc .

Download the notification here

CDSCO Notification

Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022 – Regulator’s Notification

MoHFW has released a recent notification on Sep 30th 2022 about the Registration / Licensing norms for Medical Device Manufacturers, Importers for Class A and B Devices .

Content of the notification is shared below for information purposes :

  • The Ministry of Health & Family Welfare (MoHFW) has published notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 01.04 2020.
  • In order to regulate all the medical devices, MoHFW has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class A & B medical devices will be under licensing regime from 01.10.2022.
  • In the meantime, representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2022 for Class A & B medical devices.
  • In view of the above, it has been decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Notification can be downloaded from here

Source – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw==

What the notification means ?

Manufacturers and importers of non notified devices (which are not regulated already) of Class A and B Categories were given time for 18 months timeframe – from April 2020 to Sep 30, 2021, to Voluntarily register their businesses and products sold by them in the market. This registration helps businesses to establish business identity with Regulator. Subsequent to this, thereafter, from October, 2021, Class A & B Medical Devices were brought under compulsory registration scheme up to 30th September- 2022. Regulator gave call of action to manufacturers and importers, to complete the mandatory registration process before 30th Sep 2022 as Licensing regime starts from Oct 1st 2022.

In the interim period, a draft notification was released by MoHFW inviting public comments about exempting Class A – non sterile and non measurement devices from Licensing . It was only a draft and no further announcement was made about the same. Members of the sector have assumed that this category of products was exempted . This interim notification has caused some confusion at the market place.

However, as per the recent notification, the status quo is clear where MoHFW has clarified that existing manufacturers, importers who were already manufacturing, importing Class A , B Devices in the market and who have already applied to CLA/SLA for License, after applying for voluntary or mandatory registration, can continue to operate in the market as their application for license will be deemed valid. They can continue to manufacture or import Class A, B devices for the next 6 months time from the date of this order or till the time the CLA/SLA takes a decision on the application whichever is earlier.

There are players who have not filed application under Voluntary & Mandatory registration process due to lack of awareness or various other business challenges and they are seeking clarification and guidance on how to apply now. They would like to know if they have to apply for Registration or Licensing now and if they are permitted to apply for Registration hereafter.

Some clarity and guidance from the Ministry on these concerns would certainly help the players/industry.