WAD 2022 Celebrations from CCC

2 Days Conference on Sustainability – World Accreditation Day 2022 Celebrations at Chennai on June 9-10 2022 (Hybrid Session)

About #WAD2022

June 9th 2022 marks World Accreditation Day (#WAD2022), a global initiative established by ILAC and IAF to promote the value of accreditation.

Download the following announcements :

This year’s theme :

Accreditation: Sustainability in Economic Growth and the Environment, focuses on how accreditation supports the United Nations Sustainable Development Goals – (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

#WAD Celebrations – an annual initiative from Consultants Consortium of Chennai (CCC)

CCC has been organising series of Knowledge Sessions for the benefit of the industry during WAD Month since its inception. WAD 2020 and WAD 2021 were well received by the industry. We had conducted virtual learning sessions during this period.

#WAD2022 Celebrations

WAD 2022, however would be a Hybrid Session. We are planning to organise a physical session in University Auditorium in Chennai with a target audience of around 100 -150 members (offline) and plus online viewers.

The Conference is jointly organized by International Accreditation Service (IAS), USA and Bureau of Indian Standards

International Accreditation Service

IAS is a nonprofit, public-benefit corporation that help organizations demonstrate compliance and competence to their customers, regulators and the public. IAS has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.

IAS also maintains signatory status in a number of global multilateral recognition arrangements under Asia Pacific Accreditation Cooperation (APAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). IAS is a member of the ICC Family of Solutions.

As one of the leading accreditation bodies in the United States, IAS is a signatory to the three primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide.

Bureau of Indian Standards

BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing

Keeping in view, the interest of consumers as well as the industry, BIS is involved in various activities as given below:

Standards Formulation
Product Certification Scheme
Compulsory Registration Scheme
Foreign Manufacturers Certification Scheme
Hall Marking Scheme
Laboratory Services
Laboratory Recognition Scheme
Sale of Indian Standards
Consumer Affairs Activities
Promotional Activities
Training Services, – National & International level
Information Services

Conference Theme :

Sustainability in Economic Growth and the Environment
-How accreditation supports the United Nations Sustainable Development Goals (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

Conference Sessions are built for multiple sectors touching upon the Sustainability Initiatives in various sectors and applicability of various Standards, Certifications, Accreditations , Regulations to ensure that Sustainable Products and Services are offered to Consumers.

Sustainability is a Trade Issue and World Markets are linking World Trade to Sustainability initiatives adopted by various countries.

ESG is based on standards set by lawmakers, investors, and ESG reporting organizations (e.g., GRI, TCFD, MSCI), whereas Sustainability Standards — while also set by standards groups like GHG Protocol — are more science-based and standardized.

Dates :
June 9th and 10th 2022 – Thu & Fri
Time – 10 00 am – 5 45 pm IST
Session Mode – Hybrid (Online and Physical)
Venue – Auditorium inside Anna University Campus

Who should attend ?

Sessions would be open to Accreditation Bodies, Certification Agencies, Conformity Assessment Bodies, Inspection bodies, Govt organisations, Members of Trade & Industry Associations, Chambers of Commerce, Entrepreneurial Hubs, MS Consultants, Technical Experts, Startups, Innovators

Sessions at a glance :

Program Agenda
Day 1 – Inaugural Session

Registration Details

Open to all stakeholders in Conformity Assessment.

Industry, ABs, CBs, CABs, Inspection bodies, Consultants, Technical Experts, Industry Associations, Innovators, Start-ups, Entrepreneurial Platforms, Government organisations.

There is NO REGISTRATION FEE

However prior registration is a must for participation.


Contact Co-ordinators

Ms Rama Venugopal, President
Whatsapp +91 9840870532
Email – contact@ccc-consultants.org

Mr D Srikanthan, Secretary
Whatsapp +91 9003056539
Email – secretariat@ccc-consultants.org

Secretariat Office
Phone+044 24462337 / 24462338
Email – communication@cccassociation.org

Notification from CDSCO

Fresh Notification – Voluntary Registration & Labelling Norms from CDSCO for Medical Device Industry

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. CDSCO has called for feedback , suggestion from the industry to the proposed amendments.

Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification below.

NOTIFICATION – New Delhi, the 12th October, 2021

G.S.R. 729(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to

The Under Secretary (Drugs Regulation),
Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,
New Delhi – 110011
or
emailed at – drugsdiv-mohfw@gov.in.

DRAFT RULES

(1) (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

(2) In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 19B, in subrule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

Download the Notification from CDSCO

Source : CDSCO