Table of Contents
Medical Device Registration in India
Voluntary Registration for Non-Notified Medical Devices
The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. There are two major pathways for the registration of medical devices:
- Notified Medical Device Registration
- Non-Notified Medical Device Registration
Until now, the Notified Medical Devices have been regulated (there are 37 in this list) mainly focusing on implantable devices. However, now all medical devices that do not fall under the notified scheme, need to be registered.
The voluntary registration has no Government Fee at the moment and it is a simple process wherein two main documents – ISO and FSC are needed. This process will generate a file number on the same day of application and is open for a limited time period.
The registration of Class A, B, C & D devices has been kept voluntary for a period of 18 months w.e.f. 1st April 2020 i.e till 30.09.2021,
Voluntary Registration of Class A & B devices shall be followed by Mandatory Registration for 12 months after 18 months of Voluntary registration period is over i.e. up to 30.9.2022,
From 01.10.2022 Class A & B devices will fall under licensing regime.
Voluntary Registration of Class C & D devices shall be followed by mandatory registration for 24 months after 18 months’ Voluntary registration period is over i.e. 01.10.2021 to 30.9.2023
From 01.10.2023 Class C & D devices will fall under licensing regime.
CMS is now providing services in India as well. Contact us to register your devices prior to the deadline now.
Background
This article details the Medical Device Amendments which have been amended in 2020. The history of Medical Device Regulation starts with the Central Drugs Standard Control Organization (CDSCO). The CDSCO is the Indian Advisory Body for Pharmaceuticals and Medical Devices wherein all Notified Medical Products are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for product approvals in India.
The CDSCO is responsible for approval of and regulation of Drugs, Cosmetic, IVDs and Medical Devices, control over the quality of imported devices, coordination of activities of Stage Drug Control Organization and providing expert advice with a view of of bringing about the harmonization of enforcement of the Drugs and Cosmetics Act. Manufacuturer can leverage their approvals in the US, Canada, Europe, Australia or Japan for the registration process in India (similar to ASEAN countries).
Drugs Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 is an Act of the Indian Parliament which is responsible for the regulation of importation, manufacturing and Distribution of Drugs, Cosmetics, Medical Devices and IVDs in India. the most important objective of this act is to make sure that quality standards are adhered to and every device imported into India is protected. This article focuses on the regulation if Medical Devices in India. For this, there are 2 major pathways
- Notified Medical Device Registration
- Non-notified Medical Device Registration
Notified Medical Device Registration in India
For medical device registration in India, 37 device categories have been listed as ‘Notified Medical Devices’ by the CDSCO. List of notified medical devices is given below. All the medical devices under the new rules “Medical Devices Rules, 2017” are classified as per Global Harmonization Task Force (GHTF) based on associated risks,
=> Class A (low risk)
=> Class B (low moderate risk)
=> Class C (moderate high risk)
=> Class D (high risk)
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- Substances used for in vitro diagnosis including Blood Grouping Sera
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intraocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopaedic Implants
- Internal Prosthetic Replacements
- Ablation Devices
- Ligatures, Sutures and Staplers
- Intrauterine Devices (Cu-T)
- Condoms
- Tubal Rings
- Surgical Dressing
- Umbilical Tapes
- Blood/ Blood Component Bags
- Organ Preservative Solution*
- Nebulizer (effective from 1st Jan 2021)
- Blood Pressure Monitoring Device (effective from 1st Jan 2021)
- Glucometer (effective from 1st Jan 2021)
- Digital Thermometer (effective from 1st Jan 2021)
- All implantable medical devices equipment (effective from 1st April 2021)
- CT Scan Equipment (effective from 1st April 2021)
- MRI Equipment (effective from 1st April 2021)
- Defibrillators (effective from 1st April 2021)
- PET Equipment (effective from 1st April 2021)
- X-ay Machine (effective from 1st April 2021)
- Dialysis Machine (effective from 1st April 2021)
- Bone marrow cell separator (effective from 1st April 2021)
- Disinfectants and insecticide specified in Medical Devices Rules, 2017)
- Ultrasound equipment (effective from 1st November 2020)
The process to register the above mentioned 37 devices is
Step 1: Determination of Classification of Medical Device
When a manufacturer decides to get their products registered in India, he/ she must review the CDSCO’s gazette notifications prior to making a final determination of a device’s regulatory status and classification
Step 2: Appoint of Indian Agent
The manufacturer must appoint an India Authorized Agent to interact with CDSCO. The agent chosen must have a wholesale license (Forms 20B and 21B/21C). The Indian Agent will then be granted a Power of Attorney to manage registration and importation in India.
Step 3: Compilation of Documents
The manufacturer will have to focus on compiling the following documents:
- Power of Attorney
- FSC Country of Origin
- FSC – USA, EU, Canada, Japan, Australia
- ISO certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Declaration of Conformity
- Predicate Device Information
- Labels
- IFU
- Batch release certificates for minimum 3 batches
- Audit report
- Domestic price list – Country of Origin
- Details of Product Recall
- Details of CAPA
- Post Market Surveillance Report
- Old Registration Certificate from CDSCO (if any)
- Adverse Event Globally
- Adverse Events India
- Quality Manual
- Schedule DII
- MD-14 application
Step 5: Process and Timelines
The next step is the file application for registration/ import license with the CDSCO. All documents submitted must be in English. The time period for obtaining Registration Certificate of Medical Device is 6-9 months. The clock stops once a query is raised and starts once responded to. new products without any strong predicates in India may take longer time and may require a MDAC review for approval based n the recommendations by the CDSCO. After obtaining the license, the manufacturer must understand that the license does not expire. License retention fees are due every 5 years.
Step 6: Importation
The manufacturer can import their device into India only via the Authorized Indian Agent.
Non-Notified Medical Device Registration in India
Medical Device Amendments
The CDSCO brought in new amendment on the 11th Feb 2020, wherein apart from the above mentioned 37 notified devices, all other devices which includes instruments, apparatus, appliances, and implants, irrespective of being used alone or in combination for various purposes like analysis, prevention, treatment, allaying of any disease, investigation, replacement or alteration or support of the anatomy among others, will be regulated under this legislation.
- These rules are called the Medical Devices (Amendment) Rules, 2020
- These rules shall come into force on the 1st April 2020
- In the Medical Devices Rules. 2017 (hereinafter to be referred as said rules), after Chapter III, the following Chapter IIIA shall be inserted
Registration under this chapter will be on a voluntary basis for 18 months from 1st April 2020 to 1st October 2021.
The process to obtain registration for non-notified devices under the Medical Device Amendments would be as follows:
Step 1: Check Gazette Notification
When a manufacturer decides to get their products registered in India, he/ she must review the CDSCO’s gazette notifications to understand if the product falls under a notified or non-notified category.
Step 2: Appointment of India Agent
The manufacturer must appoint an Indian Agent who will handle the submission of documents and help obtain the registration number for a non-notified device.
Step 2: Compilation of Documents
The importer will have to compile the following documents:
- Name of the company or firm or any other entity importing the medical device, specification and standards of the particular medical device
- Details of medical device
- Certificate of compliance with respect to ISO 13485 standard accredited by the National Accreditation Board for Certification. Bodies or International Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
- FSC Country of Origin
- Undertaking signed by the importer stating the information provided by the applicant is true.
Step 4: Process and Verification
Once the documents are submitted, the CDSCO will give a registration number for the particular medical device. The importer will then have to mention the registration number on the label of the medical device. The Central Licensing Authority will verify the documents at any point of time and investigate the quality and safety related failure and complaints. if the manufacturer fails to comply with the provision of the new rules, the Central Licensing Authority may cancel the registration number or suspend it for a period of time.
Step 5 Importation
The manufacturer can import their device into the country only via the Authorized Indian Agent.
