The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed regulations.
If you are in the Medical Device business or plan to manufacture, import, sell or distribute Medical Device, it is important to know the regulatory requirements, that needs to be followed. To start with, let’s first understand what the term ‘Medical Device’ means. There are many definitions available. The WHO (World Health Organization) defines; ‘Medical device’ as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- the investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
A device which comes in direct contact of a patient’s body to achieve its intended function is an In-Vivo device or a Medical Device. However, there are certain devices that do not come in direct contact of the patient but only use body fluid collected from the patient i.e. blood, tissue, smear etc. in inorder to diagnose, monitor, investigate. Such devices are categorised as an In-vitro Device (IVD).
IVDs are usually considered as a lower risk category unlike Medical Devices. The device need not be a direct-use product but can also be accessories like liquid reagents, sutures, Bone Cement, Bandages etc.
In India, the need to regulate the medical industry was first envisioned by the british government resulting in the introduction of the Drug & Cosmetics Act 1940. This act covers the pharmaceutical and cosmetics industry as well as a few critical items used in medical procedures with no special mention to the medical devices category. Though medical devices are very different from drugs with no pharmacological, immunological effect over the body, yet they are crucial in providing support to body organs, drug delivery, diagnosis, prevention or monitoring of diseases.
Prior to 1989, Only a few items were regulated under the Drug & Cosmetics Act 1940.
- In Vitro Diagnostic Reagent
- Surgical Dressings
- Umbilical Tapes
In 1989, the Government notified Disposal hypodermic Syringe, Needles and perfusion set as medical devices that need to be regulated. Thereafter in 2002 In Vitro Diagnostic kit for HIV, HbsAg, HCV and Blood Grouping Sera was also included in the notified list. In 2005, Ten more categories of Devices were included in the list of notified items. These were Cardiac stents, Drug-eluting stents, Catheters, Intraocular lenses, I.V. Cannulae, Bone Cement, Heart Valve, Scalp vein set, Orthopedic implant, Internal prosthetic replacements. In 2016, Ablation devices were included in the regulated devices list.
On January 31st, 2017 the Ministry of Health & Family Welfare (MoHFW) issued a gazette notification GSR 78(E) under Drug & Cosmetic Act 1940 and Rules 1945 as Medical Devices Rules 2017, which came into force from January 1st 2018. MDR 2017
In 2018, four more categories of devices; Nebulizer, Blood pressure monitoring devices, Digital Thermometer and Glucometer were added in the notified devices list, which would be effective from the 1st of January 2020.
All Implantable Medical Devices along with CT Scan equipment, MRI equipment, Defibrillators, Dialysis machine, PET equipment, X-Ray Machine and Bone Marrow cell separators were included in the notified regulated devices list. Implementation of this inclusion will be effective from 2020. In total 379 Medical devices and 247 IVD Devices of notified category are already listed under provision of Rule 4 of MDR.
Import, manufacture or selling a medical device in India that comes under the notified list, would require regulatory compliance as per MDR 2017. That has some mandatory requirements such as Quality Management System (QMS) implemented, Risk Management (as per ISO 14791), Device Master File (DMR). A few requirements are product specific i.e; Electrical Safety testing (ISO 60610), Medical Device Usability (ISO 62366), Biocompatibility testing (ISO 10993).
With all these things ready, one can apply for the manufacturing license to the Central Licensing authority (Class C & D) or State Licensing authority (Class A & B).
The MDR 2017 comprises 12 Chapters, 97 Rules, 8 Schedules and 40 Forms.
|Chapter 1||Short Title & Commencement, Application & definitions|
|Chapter 2||Regulation of Medical Device|
|Chapter 3||Authorities, Officers and Bodies|
|Chapter 4||Manufacture of Medical Devices for sale or for distribution|
|Chapter 5||Import of Medical Devices|
|Chapter 6||Labelling of Medical Devices|
|Chapter 7||Clinical Investigation of Medical Devices & Clinical Performance Evaluation of New In Vitro Diagnostic Medical Device|
|Chapter 8||Import of Manufacture Medical Device which does not have Predicate Devices|
|Chapter 9||Duties of Medical Device Officer, Medical Device Testing Officer & Notified Body|
|Chapter 10||Registration of Laboratory for carrying out test or Evaluation|
|Chapter 11||Sale of Medical Device|
|First Schedule||Parameters for classification of medical devices and in vitro diagnostic medical devices|
|Second Schedule||Fee payable for licence, permission and registration certificate|
|Third Schedule||Documents required for registration of Notified Body, its duties and functions|
|Fourth Schedule||Documents required for grant of licence to manufacture for sale or for distribution or import|
|Fifth Schedule||Quality Management System for medical devices and in vitro diagnostic medical devices|
|Sixth Schedule||Post Approval Change|
|Seventh Schedule||Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation|
First step is to identify the class that a device belongs to. MDR 2017 classifies both Medical and IVD device under four categories based on the risk involved.
|Class A||Low Risk|
|Class B||Low Moderate Risk|
|Class C||Moderate High Risk|
|Class D||High Risk|
The First schedule of MDR describes the parameters to classify Medical Devices and IVD Devices
Quality Management System
Having a QMS would help to achieve the quality, even if your device does not come under the notified list. Fifth Schedule of MDR 2017 describes QMS requirements that is equivalent to ISO 13485.
In Fifth Schedule, section 7.1 requires the organisation to establish documented requirements for risk management (as per the IS or ISO 14971) throughout product realisation and record to be maintained. The manner in which a startup should approach the ISO 13485, is another topic for another day as it is an involved process.
With MDR 2017, Medical Device Industry in India will now be regulated through Rules equivalent to globally prevailed existing standards i.e; FDA in USA, CE for Europe, MDSAP (Australia, Brazil, Canada, Japan). Existing manufacturers with compliance to any of these regulations, would not find it difficult to meet MDR requirements.
For those who are new to the regulatory world, following these steps would help
- Check if your device is notified or not;
- Classify the category of device;
- Identify requirements specific to your device in addition to the mandatory requirements;
- Implement the QMS
- Apply for Licence to Regulatory Authority
We hope this article would be helpful to Medtech startups, students, small manufacturers or anyone interested to know about Indian regulatory compliance.
Medical Device Rule 2017
Blog by: Mukesh Malviya (Design Head)