Procedure to obtain license for manufacturing of Medical Devices

How to obtain license for manufacturing of Medical Devices. Procedure for applying in FDA

2730
Medical Device
Medical Device
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on January 3, 2024 by The Health Master

Medical devices – Manufacturing license

In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act of 1940 and Rules made thereunder in 1945.

  1. (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant covered under sub-clause (i);
  2. (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants, and insecticides notified under sub-clause (ii); and
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;

Must read articles

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Procedure to obtain license for manufacturing of Medical Devices

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Registration for sale of Medical Devices: Procedure and conditions

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

Notified Bodies for Medical Devices

Updated list of Notified Bodies for Medical Devices

Medical Device Testing Laboratories (MDTLs)

Medical Device Alert: Lists

Forms: Medical Devices

Schedules: Medical Devices

Understanding Quality Risk Management

Importance of patent regime in pharma industry

NABL 126: Specific criteria for calibration of Medical Devices

NPPA-OM-dt-30-09-2021-increase-in-GST-rate-Medical-Devices

GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices

FAQs on Medical Devices

Click the below links:

FAQs on Medical Devices Rules, 2017    

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Bags and its Testing

FAQs on Legal Metrology & Blood Bags

FAQs – on Disinfectants (Series-1)

FAQs on Sanitizer, N95 Mask & Digital Thermometer

FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries

FAQ-Medical-Devices by CDSCOFAQ-Medical-Devices-Grouping


IVD (In Vitro Diagnostics)

  1. In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules
    1. The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
  2. In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:
    1. Low risk – Class A;
    2. Low moderate risk- Class B;
    3. Moderate high risk- Class C;
    4. High risk- Class D.
  3. Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
  4. The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:
    1. Import of all Classes of In Vitro Diagnostic Medical Device
    2. Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
    3. Clinical Performance evaluation and approval of new in vitro diagnostic medical devices 
    4. Co-ordination with the State Licensing Authorities
  5. The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-
    1. Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices
    2. Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.

Guidance documents for In-vitro Medical DEvices

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

Draft-Guidance-document-dated-07-07-2022-on-Overview-on-Performance-Evaluation-External-Evaluation-of-In-vitro-Diagnostic-Medical-Device-IVDMD

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

Draft-Guidance-document-dated-07-07-2022-on-Guidance-on-Stability-Studies-of-In-Vitro-Diagnostic-Medical-Device-IVDMD

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

Draft-Guidance-document-dated-07-07-2022-on-Guidance-on-Post-Market-Surveillance-of-In-vitro-Diagnostic-Medical-Device-IVDMD

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How to obtain manufacturing license for Medical Devices

Documents required

For obtaining manufacturing license for Medical Devices, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure

Procedure for obtaining manufacturing license for Medical Devices. Download the pdf file for more detail and prepare the documents accordingly.

Form

List of Medical Device Forms MD 1 to MD 43. Download all forms at once, and click the below link

Form-MD-1-to-Form-MD-43

To download the forms separately, click the below link

Applications Forms: All types of Medical Devices

Fee

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link


Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  300/-
Retail sale1920 & 21-do--do--do--do-
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/-
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/-
Sch. X (WSDL)19-C20-G500/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

Area required

Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre

Manufacturing area / sectionArea prescribed for basic installations (Square Metre)Ancillary Area prescribed (Square Metre)Total Area required (Square Metre)
Allopathic drugs   
External Preparations301040
Oral Liquid Preparations301040
Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Non-Beta Lactum)30 1040
Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc)602080
Coating (Beta Lactum)30 1040
Powders (oral)3030
Hard Gelatin Capsules (Beta-lactam)251035
Hard Gelatin Capsules (Non Beta-lactam)251035
Ophthalmic Preparation251035
Eye ointment, Eye lotion2525
Pessaries2020
Inhalers & Vitrallae2020
Re-packing of drugs3030
Parenteral (Small Volume Parenteral)150100250
Parenteral (Large Volume Parenteral)150150300
Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology250150400
Homoeopathic   
Mother tincture and
mother solutions
5555
Potentization section2020
Trituration, Tableting,
Pills and Globules section
5555
Syrups & other oral liquids2020
Ointments & lotions section2020
Ophthalmic Preparations2020
Packing & labelling5050
Cosmetics   
A. Powders1515
B. Skin powder for infants1515
C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade2525
D. Nail Polish and Nail Lacquers1515
E. Lipsticks and Lipgloss1515
F. Depilatories used for eyes1010
G.
1. Eyebrows, Eyelashes, Eyeliners
2. Kajal and Surma

10 10



5 For base sterilization

10 15
H. Aerosols1515
I. Alcoholic Fragrance Solutions1515
J. Hair Dyes1515
K. Tooth powders general1515
L. Toilet Soaps100100
Blood Bank / Centre   
Blood Bank / Centre
(only for Whole Human Blood)
100100
Blood Component5050
Blood Bank / Centre
including Blood Components
150150
Apheresis1010
Medical Devices
Area not prescribed in MDR 2017 for manufacturing of Medical Devices
Medicinal Gas
Area not prescribed for manufacturing of Medicinal gases
Disinfectant
Area not prescribed for manufacturing of Disinfectants
API (Bulk drug)
Area not prescribed for manufacturing of API (Bulk drugs)
Empty Capsule Shell
Area not prescribed for manufacturing of Empty gelatin Shell
Soft Gelatin Capsules
Area not prescribed for manufacturing of Soft Gelatin Capsules
Cytotoxic substances / Sex hormones
Same area required as defined for tablet section
Laboratory
Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed

Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005


Compiled by:

Lalit Kr. Goel, DSDC, FDA Haryana

Rakesh Dahiya, SDCO, FDA Haryana


Download area requirement

Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre


Sugam Portal

Submit your application (Online at SUGAM Portal) after completing all the required documents. Click the link below for SUGAM Portal:

SUGAM Portal

Note: Requirements of some of documents and procedure for submission of application may vary from State to State

License retention fee

Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.


Medical Device Testing Laboratories (MDTLs)

Central Govt. time to time notifies Medical Devices Testing Laboratories. For more details click below links:

List of MDTLs

DCGI-dt-21-11-2022-28-MDTLs-Updated-list-of-medical-devices-testing-laboratory-MDTL-registered-with-CDSCO-under-MDR-2017

DCGI-Notice-dt-17-08-2022-List-of-the-Certified-Medical-Device-Testing-Laboratory-under-MDR-2017-MDTLs

DCGI-Dt-05-05-2022-Updated-list-of-laboratories-for-conducting-Performance-evaluation-of-IVD-reagents-kit

DCGI-Dt-11-04-2022-List-of-the-21-Certified-Medical-Device-Testing-Laboratory-under-MDR-2017

DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017

DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs

CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs

S.O.-2237E-dt-01-06-2018-Notification-of-5-Central-Medical-Device-Testing-Laboratories


List of Notified bodies

List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023

List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023

List of Notified Bodies (13) registered with CDSCO under MDR, 2017 as on 09-03-2023

List-of-Notified-Bodies-13-registered-with-CDSCO-under-MDR-2017-as-on-09-03-2023

List of Notified Bodies registered with CDSCO under MDR, 2017 as on 25-08-2022

List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017-as-on-25-08-2022

DCGI dt 11-11-2021 – List of Notified Bodies registered with CDSCO under MDR-2017

DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017

Central Govt. has notified 8 Notified Bodies on 30-12-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:

Central Govt. has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:

Medical Devices have been divided into four categories i.e. A, B C & D. For more details of classification of Medical Devices dated 15-05-2019, click below:


Medical Devices Categories / Classification

2022

DCGI Notice dt 09-09-2022 Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures

DCGI-Notice-dt-09-09-2022-Classification-of-Medical-Device-Pertaining-to-non-sterile-non-powered-hand-held-or-hand-manipulated-Surgical-Instruments-for-general-use-intended-to-be-used-in-various-general-surgical-procedures

DCGI Notice dated 04-08-2022 Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017

DCGI-Notice-dated-04-08-2022-Classification-of-Medical-Device-Pertaining-to-Rehabilitation-under-the-Provisions-of-Medical-Devices-Rules-2017

DCGI notice dated 06-07-2022 Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017

DCGI-notice-dated-06-07-2022-Classification-of-Medical-Device-Pertaining-to-Rehabilitation-under-the-Provisions-of-Medical-Devices-Rules-2017

DCGI Notice dated 03-06-2022 Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017

DCGI-Notice-dated-03-06-2022-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-Medical-Devices-Rules-2017

DCGI Notice dated 03-06-2022 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017

DCGI-Notice-dated-03-06-2022-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-Medical-Devices-Rules-2017

DCGI notice dt 16-03-2022 Classification of Medical Device pertaining to General Hospital Orthopaedic instruments under the provisions of Medical Devices Rules 2017

DCGI-notice-dt-16-03-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-Orthopaedic-instruments-under-the-provisions-of-Medical-Devices-Rules-2017

DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017

2021

DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017

DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017

DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017

DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017

DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017

DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017

DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017

DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017

DCGI Notice dt 09-08-2021 – Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017

DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017

DCGI Notice dt 06-08-2021 – Classification of Medical Devices Pertaining to ENT under MDR 2017

DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017

DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Respiratory Under MDR 2017

DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017

DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Radiotherapy under MDR 2017

DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017

DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Rehabilitation under MDR 2017

DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017

DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Physical Support under MDR 2017

DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017

DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017

DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017

DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017

DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017

DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Cardiovascular under MDR 2017

DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017

DCGI Notice dt 23-07-2021 – Classification of In Vitro Diagnostic Medical Devices under MDR 2017

DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017

DCGI Notice dt 12-07-2021 – Classification of Medical Devices pertaining to Anesthesiology under MDR 2017

DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017

2020

DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020

DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020

2019

DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices

MRPs of Medical Devices

NPPA Office Memorandum dt 23-07-2021 – for Revised MRPs in pursuance to the TMR Notification for 5 Medical Devices

NPPA-Office-Memorandum-dt-23-07-2021-–-for-Revised-MRPs-in-pursuance-to-the-TMR-Notification-for-5-Medical-Devices

NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices

NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices

NPPA Dt 09-06-2021 – Office Memorandum -Revised MRP for Oxygen Concentrators

NPPA-Dt-09-06-2021-Office-Memorandum-Revised-MRP-for-Oxygen-Concentrators

NPPA Office Memorandum dt 04-06-2021 In pursuance to the Notification dated 03.06.2021 for Oxygen Concentrators

NPPA-Office-Memorandum-dt-04-06-2021-In-pursuance-to-the-Notification-dated-03.06.2021-for-Oxygen-Concentrators

NPPA order dt 03-06-2021 Price Cap for Oxygen Concentrator through Trade Margin Rationalisation Approach

NPPA-order-dt-03-06-2021-Price-Cap-for-Oxygen-Concentrator-through-Trade-Margin-Rationalisation-Approach

NPPA Office Memorandum dt 15-05-2021 for call of MRP Data for Pulse Oximeter & Oxygen Concentrator 2021

NPPA-Office-Memorandum-dt-15-05-2021-for-call-of-MRP-Data-for-Pulse-Oximeter-Oxygen-Concentrator-2021

National Medical Device Policy

National Medical Devices Policy 2023

National Medical Devices Policy 2023

National Medical Devices Policy 2023

Draft National Medical Device Policy 2022

DoP notice dt 10-03-2022 Releases draft National Medical Device Policy 2022

DoP-notice-dt-10-03-2022-Releases-draft-National-Medical-Device-Policy-2022

Uniform Code for Medical Device Marketing Practices

DoP dt 16-03-2022 Draft Uniform Code for Medical Device Marketing Practices

Bureau of Indian Standards (BIS) of Medical Devices

Bureau of Indian Standards (BIS) of Medical Devices, click below link:

DoP-Notice-dt-01-02-2022-List-of-standards-of-Bureau-of-Indian-Standards-BIS-for-Medical-Devices

Fifth Schedule QMS

Medical Devices manufacturing units have to maintain the facilities as per Fifth Schedule,

Quality Management System for medical devices and in vitro diagnostic medical devices. For more details, click below:

List of Laboratory Instruments

We have provided list of laboratory instruments, click below link to exploxe:

List of Laboratory Instruments for Pharma & Cosmetics Industry

NABL for Medical Devices

Click below link for more details:

NABL


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NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices

NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices

DCGI Notice dt. 31-08-2020 – requirement of fees for change in address of authorized agent under MDR 2017

DCGI Notice dt 31-08-2020 – Submission of notarized documents for import of medical devices and In-Vitro kits in view of Covid-19

Additional information for Medical Devices

For additional information for Medical Devices, click below:

Medical Devices Rule 2017

To download Medical Devices Rule 2017, click below

Registration and labelling requirements of Medical Devices

GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices

Guidelines on registration of Medical Device

DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices

Medical Device Alert

Medical Device Alert, click the below link

Medical Device Alert: Lists


Medical Device Notifications

For various notifications of medical devices, click the below link:

Notifications – Medical Devices

Notifications – Drugs Act

Notifications – Drugs Rule

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