CAHO Webinars

Webinar on Understanding Technical Regulations and Standards

Healthcare services rely on a number of products – from drugs to medical devices to food to electronic items. Many of these items not only need to be of high quality but also safe to use.

Since many products have health and safety implications, they are or should be regulated while others may not need to be regulated but quality needs to be assured.It is therefore necessary for healthcare industry to understand the world of what are called technical regulations and standards, how it should go about procurement of products it needs and what kind of certificates it should rely on

CAHO is hosting a webinar on the topic Understanding Technical Regulations and Standards by Mr.Anil Jauhri , (Former CEO,National Accreditation Board for Certification Bodies (NABCB)) on 23rd March 2023 between 4.00 to 5.30 pm.

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:

➢ Accounting and Auditing Services

➢ Educational Services

➢ Healthcare Services

➢ Architectural, Construction & Related Engineering, Environmental Services

➢ KPO/ ITO Services

➢ Logistics Services

➢ Tourism Services

➢ Entertainment Services

➢ Other Professional services

Benefits you may get while participating at BSM to ASEAN region.

• Focused pre scheduled B2B meetings in each country

• Understand the market potential from experts in ASEAN region.

• Networking Opportunities with potential buyers in ASEAN region.

• Generate business leads and sign MOUs for collaborations.

• Meetings with relevant government and related stakeholders.

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry

THE MEDICAL DEVICES RULES, 2017

THE MEDICAL DEVICES RULES, 2017

The draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government.

All objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the Medical Devices Rules, 2017

These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018

These rules shall be applicable in respect of,—
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 2 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Source:https://www.drugscontrol.org/pdf/Medical%20Devices%20Rules,%202017.pdf

Andhra Chamber – Business Delegation Tour

Andhra Chamber – Business Delegation to Vietnam Expo April 2023

Andhra Chamber of Commerce has been organising Business Delegations to various countries for the members to explore export / business opportunities. Due to Covid 19 Pandemic, we could not organise the delegation in the last three years.

Vietnam is one of the fast-growing countries in Asia, even worldwide and now since the travel industry has also opened up, the Chamber is planning for a Business Delegation to Vietnam.

The Vietnam Expo happens every year and this year it is happening in the first week of April 2023. The Expo targets many sectors like Agricultural products, Food & Beverage, Machinery & Supporting industries, Digital technology & E-commerce; Electric & Electronics; Home Living, Trade promotion; Logistics & services etc.,

The details of the delegation along with the Registration form are enclosed and we invite you to be part of this Delegation to expand your business.

Last date of Registration is extended to 04th March 2023. Please fill up and send the registration form to enable us to enroll you for the Business Delegation to Vietnam.

For any further clarifications, please feel free to contact:

Ms.R.Vijayalakshmi
Secretary General,
Andhra Chamber of Commerce,
“Velagapudi Ramakrishna Bldg.”
No. 23, Third Cross Street,
West CIT Nagar, Nandanam,
Chennai-600035.
Phone: 24315278/79
Email: andhrachamber1@gmail.com
Web: http://www.andhrachamber.com

Announcement – ISO 45002:2023 Guidance Document published by ISO

ISO 45002:2023 Occupational health and safety management systems — General guidelines for the implementation of ISO 45001:2018

As we all know, an organization is responsible for the occupational health and safety (OH&S) of its workers. This responsibility includes promoting and protecting their physical and mental health and for taking steps to protect others who may be affected by its activities. This is best achieved through an OH&S management system.

ISO 45002’s main goal is to instruct businesses on how to implement one of these systems within their workplace.

In short, this document gives guidance on the establishment, implementation, maintenance, and continual improvement of an OH&S management system that can help organizations conform to ISO 45001.

In addition, for illustration, most of the clauses in ISO 45002:2023 include real life examples of how different types of organization have implemented the requirements.

The OH&S management system approach that ISO 45002 addresses is founded on the concept of Plan-Do-Check-Act (PDCA). It can be applied to an OH&S management system and to each of its individual elements, as follows:

  • Plan: determine and assess OH&S risks, OH&S opportunities and other risks and other opportunities that can influence the intended outcomes of the OH&S management system, establish OH&S objectives and processes necessary to deliver results in accordance with the organization’s OH&S policy;
  • Do: implement the processes as planned;
  • Check: monitor and measure activities and processes with regard to the OH&S policy and OH&S objectives, and report the results;
  • Act: take actions to continually improve the OH&S performance to achieve the intended outcomes.

The PDCA concept outlined above is an iterative process used by organizations to achieve continual improvement. This is intended to help companies implement the ISO 45001 standards effectively and to routinely maintain them as their workplace evolves

Source:https://www.iso.org/standard/76619.html

Announcement – ICAI issues Social Audit Standards

Social Audit Standards – Sustainability Reporting

The Institute of Chartered Accountants of India (ICAI) has issued the Social Audit Standards (SAS) for the members. These Social Audit Standards will be applicable from the date of their hosting on ICAI website. (SAS 100 should be read in conjunction with the “Preface to the Social Audit Standards” and “Framework for the Social Audit Standards”, issued by the ICAI

This Social Audit Standard relates to the thematic area of “eradicating hunger, poverty, malnutrition and inequality’’. The Standard aims to provide the Social Auditor with the necessary guidance in relation to independent impact assessment engagement of Social Enterprises engaged in eradicating hunger, poverty, malnutrition and inequality and the audit steps and procedures that should be applied while conducting the social impact assessment. The Standard sets out the minimum requirements to be followed while conducting impact assessment. Laws or regulations may establish additional requirements which should be followed, as applicable.

The Social Auditor should conduct a desk review of existing documents to gain further insight into the evaluation procedure and impact assessment.

The social auditor should review the evaluation questions addressed through Questionnaires, In – depth Interviews and Focused Group Discussions to assess the responses received from various stakeholders and to understand what has changed.

The Social Auditor should review the project/program documents to frame the evaluation criteria for assessing impact. Such key metrics may be collated from base-line, mid-line (monthly / quarterly) and end-line assessment (if available), respectively at the beginning, middle and end of the reporting period/project/program to effectively understand and evaluate impact.

The Social Auditor should identify the inherent limitations of the evaluation process which might have an influence on the impact assessment.

Source – https://resource.cdn.icai.org/72658srsb58573.pdf;

Source: https://www.taxscan.in/icai-issues-social-audit-standards/245984/

Admission Open – ISO 13485:2016 – Lead Auditor Training

ISO 13485:2016 – Lead Auditor Training Program (Medical Device Quality Management Systems )

Indian Biomedical Skill Consortium (IBSC) is conducting Lead Auditor Training Program on ISO 13485:2016 standard.

Program Details are given below:

Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )

Certificate: CQI & IRCA Certified Course

Duration: 5 Days (23rd – 27th January 2023)

Last date for Registration : 12th January 2023

Location: Kalam Convention Center, AMTZ Campus, Vizag

Program Details: https://ibsc-amtz.in/coursedetails/23

For quotation send email to n.nareshkumar@ibsc_amtz.in
➖➖➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

Source: https://ibsc-amtz.in/

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.

Notified Bodies registered with CDSCO under MDR 2017

List of Notified Bodies registered with CDSCO under MDR 2017

CDSCO has released the list of Notified Bodies registered with CDSCO under Medical Devices Rules 2017 to carry out audit of manufacturing site under the provisions of said rules.

Please click the link below to know the list of registered Notified Bodies