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

Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Pharma Sector Global Standards

Government of India launches scheme for pharma sector to step up capacity, upgrade to global standards

Move from Volume to Value

Support to Pharma clusters and MSME units to enhance quality and technology improvement

In the launch event of DoP’s Strengthening of Pharmaceuticals Industries – Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare urges the Pharma Industry to make India a global leader in pharma sector and utilize the scheme to upgrade MSMEs to high standards.

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries at Dr Ambedkhar International Convention Centre, Janpath, New Delhi, in the presence of  Minister of State for Chemicals & Fertilizers and New & Renewable energy Shri Bhagwanth Khuba amidst the strong presence of pharma MSME industry players and representatives of major Pharma Associations. 

The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

The Scheme provides for credit linked capital and interest subsidy for Technology Upgradation of MSME units in pharmaceutical sector, as well as support of up to Rs 20 crore each for common facilities including Research centre, testing labs and ETPs in Pharma Clusters. SIDBI will be the Project management Consultant for implementing the scheme.

The Chemicals and Fertilisers Ministry rolled out the schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI). SIDBI will be the project management consultant for implementing the scheme

Union Minister for Chemicals and Fertilisers Mansukh Mandaviya said the schemes envisage technology upgradation, setting up of common research centres and effluent treatment plants in clusters for the pharma MSMEs and Small companies should be able to upgrade their facilities to global manufacturing standards.

The scheme has three components:

 Assistance to Pharmaceutical Industry for Common Facilities (APICF) – would strengthen the existing pharmaceutical clusters’ capacity for sustained growth. It provides for an assistance of up to 70 per cent of the approved project cost or Rs 20 crore, whichever is less.

 Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – would facilitate pharmaceutical MSMEs with proven track record to upgrade their technology. The scheme has provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs 10 crore with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis

 Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry. The scheme is aimed at creating a database of pharma and medical device sectors

Information Source : https://www.moneycontrol.com/news/trends/current-affairs-trends/government-launches-scheme-for-pharma-sector-to-step-up-capacity-upgrade-to-global-standards-8862561.html

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1843560

CDSCO Notification

Central Drugs Standard Control Organisation – Notification dated 11th July 2022

In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class A & Class B categories are scheduled to enter licensing regime with effect from 01.10.2022

The Manufacturers are required to register their products on the portal (https://cdscomdonline.gov.in/NewMedDev/Homepage#) established for the purpose by CDSCO and to affix the registration number on the label of such registered medical devices.

All manufacturers are advised to apply for obtaining manufacturing license for Class A & Class B medical devices through CDSCO’s on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay.

CDSCO has also clarified that the quality certificates issued by any other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All manufacturers shall have to comply with the licensing requirement and obtain the license as per MDR, 2017, as the said rules do not recognize any such certificates which are not mentioned in it or part of it.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3MA==

Workshop on Patient Safety and Quality Improvement

Education/Interactive Workshop on Documentation Requirement for Patient Safety and Quality Improvement

NABH is organising a Workshop on Documentation Requirement for Patient Safety and Quality Improvement on Sunday, July 17, 2022 between 2 pm to 6 pm.

Like all quality management systems documentation is an essential component of NABH accreditation. NABH standard require various documentation. Documentation which provides correct, complete, current, and consistent information and also effectively meet customer and stakeholder’ requirements should exist in an organisation who is aspiring to implement quality standards.

Who should attend?

1. Medical and Nursing professionals 
2. AYUSH  professionals
3. Administrators
4. Healthcare Management Students
5. Quality Managers

Why one should attend?
1.This training will provide knowledge with which one can create required documents for his / her organisation. This workshop is also going to equip the participant with knowledge about system documentation and how to create hierarchy of policy then procedure and then Work instructions or Standard Operating Procedures (SOP). All documentation moves from one level to the next. The first tier of documentation is the policy. This is the document that defines what will be done and why. Policy needs to be clear, precise and practical, and easy to understand. The second tier of documentation is procedures. Procedures describe the methods that will be used to implement and perform the stated policies. Work instructions or Standard Operating Procedures (SOP) are usually department, machine, service, or task oriented and describe how a job will be done. The instructions are the most detailed of the documentation hierarchy.

2. What constitutes Good Documentation? How to

·  Approve, review and update documents.
·  Changes & current revision status of documents identified
·  Keep relevant versions of applicable documents available at points of use
·  Ensure that documents remain legible and readily identifiable
·  Ensure that documents of external origin identified and their distribution controlled
·  Prevent unintended use of obsolete documents, and archiving.

3. This training will strengthen the understanding of quality principles hence enabling well trained professional to become “Champions” in quality and to apply them to improve quality & work flow.

4. Trained Professionals will learn how quality can reduce errors and hence increase patient safety.

Course material and certificate for participants

Each workshop participant receives course contents including learning and reference material. The workshop will be a combination of theory, demos and panel discussions and will involve active participation.

At the successful completion of workshop candidates will be provided certificate of participation.

Workshop Fee:

The registration can be done by filling the registration format at our web-site (www.nabh.co/login). Registration fee (non-refundable & non-transferable) is Rs. 4,000/- + GST@18% (Total Rs. 4720/). Fees concession of 10% is being provided for the members of Quality Council of India (http://www.qcin.org/nbqp/PMS/).  

Limited seats are available only first come first serve basis. To ensure your participation through online registration.

Programme Date : 17th July, 2022
Programme Timings: 02.00 pm to 06.00 pm

For registration and any other related query please contact      

Mr. Vikash Chaudhary
Administrative Officer
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor, 4 – A, Ring Road, I P Estate,
New Delhi – 110002
Tel: +91 11 42600622 
Fax: +91 11 233 23 415
Email: vikash@nabh.co

PHDCCI Conference

Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices

Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:

Day & Date: Friday, 15 July 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights

• 7 Basic Quality Management Principles
• Overview of the Certification process and
• Importance of 13485 Certification from Compliance perspective

Key Speakers

• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi
• Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZYtdOyspjsuGNEyI95QZr_wRhoB9giV413X

You may send your questions to rimneet.kaur@phdcci.in prior to the session. The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

MDR 17 – An Interactive Session with Regulators

Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17

Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17

Date : 23rd July 2022 Saturday
Time : 3 pm – 5 pm
Meeting : Online Meeting

Program Objective:
Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.

Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.

Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.

AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.

Target Audience

Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu

Program Details:

Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .

There is NO REGISTRATION FEE. However , prior registration is a must.

For Enquiries about the Program :
Ms Rama Venugopal, Jt Coordinator,
AIMED – South India
jt.coordinator.south@aimedindia.com

Hub Co-ordinator
NHHID Hub, Anna University, Chennai
au.nhhid@gmail.com
For more details about the NHHID, Anna University , pls visit – https://www.nhhid.org