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 below links:

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

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

19 Medical devices added in Public Procurement Policy

FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries

FAQs – on Drug Permission in Brand or Generic Name

FAQs on Sanitizer, N95 Mask & Digital Thermometer

FAQs on Medical Devices Rules, 2017

Understanding Quality Risk Management

Importance of patent regime in pharma industry

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.

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.

Documents-required-for-obtaining-Mfg-license-for-Medical-Devices

Procedure

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

Procedure-for-obtaining-Mfg-license-for-Medical-Devices

Forms

List of Form MD 1 to MD 40 of Medical Devices, click below link to read or download the desired Form:

Medical-Devives-Form-MD-1-to-MD-40

Click for all other application forms

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.

Procedure-for-License-retention-fee

Medical Device Testing Laboratories (MDTLs)

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

List of 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

List of Notified bodies

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:

List-of-notified-bodies-8-as-on-30-12-2019

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:

List-of-Notified-bodies-6-as-on-31-07-2019

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

DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital 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

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

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-24-categories-of-MD-reference-SO-648E-and-GSR-102E-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

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

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

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

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:

Medical-Devices-Fifth-Schedule-QMS

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

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-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

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:

Additional-information-MDR-2017

Medical Devices Rule 2017

To download Medical Devices Rule 2017, click below

Medical-Device-Rules-2017

Registration and labelling requirements of Medical Devices

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

Guidelines on registration of Medical Store

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

Medical Device Notifications

For various notifications of medical devices, click below link:

Notifications - Medical Devices

Notifications – Drugs Act

Notifications – Drugs Rule

Click here for more articles on Medical Devices
https://thehealthmaster.com/2021/07/15/procedure-to-obtain-license-for-manufacturing-of-medical-devices/