Last Updated on November 29, 2024 by The Health Master
Procedure to obtain Medical devices – Manufacturing license
In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- (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);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- 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
Click the below links:
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
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)
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)
- 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
- The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
- 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:
- Low risk – Class A;
- Low moderate risk- Class B;
- Moderate high risk- Class C;
- High risk- Class D.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
- The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:
- Import of all Classes of In Vitro Diagnostic Medical Device
- Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
- Clinical Performance evaluation and approval of new in vitro diagnostic medical devices
- Co-ordination with the State Licensing Authorities
- 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-
- Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices
- 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 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)
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.
Forms
List of Medical Device Forms MD 1 to MD 43. Download all forms at once, and click the below link
To download the forms separately, click the below link
Applications Forms: All types of Medical Devices
Fee
License fee structure for all licenses
| Types of Licenses | Application Form | License on Form | Fee | Renewal / Retention fee | Late fee | Duplicate license | Fee per item |
| Drug Sale Licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3,000/- | 3,000/- | 2% | 300/- | – |
| Retail sale | 19 | 20 & 21 | 3,000/- | 3,000/- | 2% | 300/- | – |
| Homeopathic (WSDL) | 19-B | 20-D | 2,000/- | – | – | – | – |
| Homeopathic (RSDL) | 19-B | 20-C | 2,000/- | – | – | – | – |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | 500/- | 2% | 150/- | – |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | 500/- | 2% | 150/- | – |
| Drug Manufacturing Licenses | |||||||
| Manufacturing (Non- Biological) | 24 | 25 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing Schedule X | 24 F | 25 F | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
| Loan License (Biological) | 27-A | 28-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| Loan License (Non- Biological) | 24-A | 25-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| LVP | 27-D | 28-D | 7,500/- | 7,500/- | 2% | No | 300/- |
| Cosmetics Manufacturing Licenses | |||||||
| Manufacturing | COS 5 | COS 8 | 10,000/ | 10,000/- | 2% | – | 500/- |
| Loan License | COS 6 | COS 9 | 10,000/ | 10,000 | 2% | 500/- | |
| Laboratory | COS 22 | COS 23 | 1,000/- | 1,000/- | 2% | 100/- | – |
| Additional Section | – | – | 10,000/ | – | – | – | – |
| Free Sale | – | – | No fee | – | – | – | – |
| Medical Devices Manufacturing Licenses | |||||||
| Medical Devices (A& B) | MD-3 | MD-5 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (C& D) | MD-7 | MD-8 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Medical Devices Loan License (C& D) | MD-9 | MD-10 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Registration of Medical Devices Laboratory | MD-39 | MD-40 | 20,000/- | 20,000/- | 2% | – | – |
| Sale License | MD-41 | MD-42 | 3,000/- | 3,000/- | 2% | – | – |
| Free Sale certificate | 1,000/- for each category |
| Other Licenses | |||||||
| Blood Centre | 27-C | 28-C | 7,500/- | 26-G | 1,000/- | No | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 2,000/- For any no. of single ingredient | – | – | – | 200/- Per product of combination |
| Approval of Commercial testing Lab | 36 | 37 | 7,500/- | 7500/- | 2% | – | – |
| Repacking Non-Biological | 24-B | 25-B | 700/- | 700/- | 2% | 1,000/- | 100/- |
Compiled by:
Lalit Kr. Goel, DSDC, FDA Haryana
Rakesh Dahiya, SDCO, FDA Haryana
Download fee structure
Click below link to download the fee structure of all types of drug licenses
Area required
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre
| Manufacturing area / section | Area prescribed for basic installations (Square Metre) | Ancillary Area prescribed (Square Metre) | Total Area required (Square Metre) |
| Allopathic drugs | |||
| External Preparations | 30 | 10 | 40 |
| Oral Liquid Preparations | 30 | 10 | 40 |
| Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Non-Beta Lactum) | 30 | 10 | 40 |
| Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Beta Lactum) | 30 | 10 | 40 |
| Powders (oral) | 30 | – | 30 |
| Hard Gelatin Capsules (Beta-lactam) | 25 | 10 | 35 |
| Hard Gelatin Capsules (Non Beta-lactam) | 25 | 10 | 35 |
| Ophthalmic Preparation | 25 | 10 | 35 |
| Eye ointment, Eye lotion | 25 | – | 25 |
| Pessaries | 20 | – | 20 |
| Inhalers & Vitrallae | 20 | – | 20 |
| Re-packing of drugs | 30 | – | 30 |
| Parenteral (Small Volume Parenteral) | 150 | 100 | 250 |
| Parenteral (Large Volume Parenteral) | 150 | 150 | 300 |
| Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology | 250 | 150 | 400 |
| Homoeopathic | |||
| Mother tincture and mother solutions | 55 | – | 55 |
| Potentization section | 20 | – | 20 |
| Trituration, Tableting, Pills and Globules section | 55 | – | 55 |
| Syrups & other oral liquids | 20 | – | 20 |
| Ointments & lotions section | 20 | – | 20 |
| Ophthalmic Preparations | 20 | – | 20 |
| Packing & labelling | 50 | – | 50 |
| Cosmetics | |||
| A. Powders | 15 | – | 15 |
| B. Skin powder for infants | 15 | – | 15 |
| C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade | 25 | – | 25 |
| D. Nail Polish and Nail Lacquers | 15 | – | 15 |
| E. Lipsticks and Lipgloss | 15 | – | 15 |
| F. Depilatories used for eyes | 10 | – | 10 |
| G. 1. Eyebrows, Eyelashes, Eyeliners 2. Kajal and Surma | 10 10 | – 5 For base sterilization | 10 15 |
| H. Aerosols | 15 | – | 15 |
| I. Alcoholic Fragrance Solutions | 15 | – | 15 |
| J. Hair Dyes | 15 | – | 15 |
| K. Tooth powders general | 15 | – | 15 |
| L. Toilet Soaps | 100 | – | 100 |
| Blood Bank / Centre | |||
| Blood Bank / Centre (only for Whole Human Blood) | 100 | – | 100 |
| Blood Component | 50 | – | 50 |
| Blood Bank / Centre including Blood Components | 150 | – | 150 |
| Apheresis | 10 | – | 10 |
| 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:
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-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
Notified Bodies for Medical Devices
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
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 Categories / Classification
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:
2022
DCGI Notice dt 11-10-2022 Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017
DCGI Notice dt 10-10-2022 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017
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 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 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 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
2021
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to General Hospital under the provisions 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 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 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 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 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 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
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 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 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
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 explore:
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL for Medical Devices
Click below link for more details:
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 Devices
Medical Device Alert
Medical Device Alert, click the below link
Medical Device Notifications
For various notifications of medical devices, click below link:
Notifications – Medical Devices
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