Enrolment of Medical Colleges as ADR monitoring centers under PvPI

NMC Mandate Enrolment of Medical Colleges as ADR monitoring centers under PvPI

Aiming to uplift regulatory standards for the overall collection, analysis and monitoring of Adverse Drug Reactions (ADRs) from the Public, National Medical Commission (NMC) has directed all medical colleges, standalone PG Institutions to enrol themselves as Adverse Drug Reaction Monitoring Centers with the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Program of India (PvPI) at the earliest.

Indian Pharmacopoeia is functioning as the National Co-ordination Centre, Pharmacovigilance Programme of India to collect, analyse and monitor the adverse drug reactions from the Indian population to promote Patient Safety and Safeguard the health of patients by ensuring that the benefits of the use of medicines outweigh the risk associated with its use

The collected ADRs data is a significant source of evidence of recommendations of regulatory interventions regarding the safety of medicines to the Central Drugs Standard Control Organisation (CDSCO)       

In order to achieve the above objective, IPC has so far enrolled 652 Adverse Drug Monitoring Centres (AMCs).

In the 22 nd Meeting of the Governing Body of India Pharmacopoeia Commission held on 14.10.2022 under the chairmanship of the Secretary (HFW) it has been decided that all Medical colleges/ hospitals under the National Medical Commission should also be enrolled as AMCs with IPC.

Accordingly, all Medical colleges/hospitals under the National Medical Commission are directed to get themselves enrolled with Indian Pharmacopoeia Commission (IPC) as AMCs at the earliest.

Source:https://medicaldialogues.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

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

Regulatory Updates for IVDMD

Recent Regulatory Updates from CDSCO for IVD Medical Devices in India

Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.

In a review meeting held last week, Union Health Minister Mansukh Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.

He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action

The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness.

A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year,  while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

IVDs are also Medical Devices and are subject to the same regulatory framework.

In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc5Mw==

PCR Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mg==

Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mw==

Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software – 2022-May-05

Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit – 2022-May-05

Classification in IVD medical devices under the provision of MD Rules 2017 -2021-Jul-23

Source – https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/

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==

Medical Device Regulations Update

No extension in deadline for registration of medical devices to manufacturers – Announcement from Union Health Minister

Medical Devices in India will come under the licensing regime from October 1 as notified by the Central Government. Class A and B Device manufacturers, importers have to in compliance with MDR 17 and should have Registration and Licensing in place before Oct 1 2022 to have market access.

Union Health Minister Shri Mansukh Mandaviya has stated in a recent press release that there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe. He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration for seamless process.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action after Oct 1 , 2022. The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon.

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

Source :
https://health.economictimes.indiatimes.com/news/policy/no-extension-in-deadline-for-registration-of-medical-devices-mandaviya-to-manufacturers/93112960?utm_source=twitter_web&utm_medium=social&utm_campaign=socialsharebuttons

PHDCCI Conference

Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)

Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:

Day & Date: Friday, 24 June 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights
• Regulation of medical devices and recent amendments
• Steps to Licensing for Class A & Class B Devices/Products
• QMS requirements for Medical Devices
• Demonstrating Product Compliance as per MDR-17
• Challenges faced by Medical Devices Manufacturers

Key Speakers
• Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications
• Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi
• Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

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

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.