Cover Story

INVITING FEEDBACK FROM INDUSTRY
FOR
DRAFT medical device regulation Bill, 2006

• This Act may be called The Medical Device Regulation Act, 2006

• The optimum assurance of medical device safety has several essential elements, viz.:

- Absolute safety cannot be guaranteed

- It is a risk management issue

- It is closely aligned with device effectiveness /performance

- It must be considered throughout the life span of the device

- It requires shared responsibility among the stakeholders

• Definitions :

The Medical Devices Regulation Bill, 2006 has defined numerous definitions including ……..

1. Manufacturer :

“manufacturer” means –

1. the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, or in the name of a firm or company, regardless of whether these operations are carried out by that person by himself or on his behalf by a third party; or

2. any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

2. Medical Device

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article :

1. intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose (s) of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- 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 for medical or diagnostic purposes by means of in vitro examination of specimens derived
  from the human body;

2. which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means;

The draft Bill further defines :

• Notified Body

• Performance

• Risk

• Risk Management

• Medical Device Regulatory Authority Of India
  
  The Central Government shall, by notification, establish a body to be known as the Medical Device Regulatory Authority of India (hereinafter called as MDRA) to exercise the powers conferred on, and to perform the functions assigned to, it under this Act.
  
  The MDRA shall be a body corporate by the name afore said, having perpetual succession and a common seal with power to acquire, hold and dispose of property, both movable and immovable, and to contract and shall, by the said name, sue or be sued.
  
  The head office of the MDRA shall be at New Delhi.
  
  The MDRA may, in its discretion, establish its regional offices at any other place in India also.

• Objects and Functions of MDRA
  
  It shall be the objective of the MDRA to regulate and monitor the design, testing & evaluation, manufacture, packaging, labeling, import, sale, usage and disposal of medical devices, to ensure availability of safe medical devices for human use in the country. The draft Bill has further defined the objectives of MDRA.

• Technical Panels
  
  The MDRA shall, and as and when deemed necessary, establish Technical Panels, which shall consist of independent scientific experts.

The Technical Panel shall invite appropriate representative of the relevant segments of the industry besides representatives of the medical professional representatives for deliberations so as to ensure harmonious coordination in planning and control of the activities.

MDRA shall create the following three Technical panels as standing panels for matters pertaining to:

1. Classification of medical devices and disputes regarding the same

2. Conformity assessment and Technical standards

3. Medical device testing and evaluation

The MDRA may also establish as many Technical panels as it considers necessary on matters such as:

1. Good manufacturing practices and quality systems

2. Medical device packaging and sterilization

3. Medical instrumentation and radiation safety and also

4. Sector wise such as
   
   i) Anesthesiology and Respiratory Therapy Devices
   ii) Cardiovascular devices
   iii) Dental products
   iv) ENT devices
   v) Gastroenterology and Urology devices
   vi) Plastic surgery devices
   vii) Obstetrics and Gynecology devices
   viii) Ophthalmic devices
   ix) Orthopedic and Rehabilitation devices
   x) Hospital disposables
   xi) Neurological devices
   xii) Radiological devices
   xiii) Biological devices
   xiv) and combinational products

5. Risk Management of medical devices and risk benefit assessment

• Essential Principles of Medical device safety and performance :

The MDRA shall be bound by the following essential principles while regulating safety and performance of medical devices, viz.:

• Use of medical devices should not compromise health and safety

• Design and manufacture of medical devices must conform with safety principles

• Medical devices should be suitable for the intended purpose

• Long-term safety must be assured

• Medical devices should not be adversely affected by transport or storage

• Benefits of medical devices must outweigh any side effects

• MDRA shall issue regulations relating to :

1. Essential principles of Safety and Performance of medical devices

2. Design and Manufacturing requirements bearing in mind the following:

i) Chemical, physical and biological properties
ii) Infection and microbial contamination
iii) Manufacturing and environment properties
iv) Devices with a diagnostic or measuring function
v) Protection against radiation
vi) Requirements for medical devices connected to or equipped with an energy source
vii) Protection against mechanical risks
viii) Protection against the risks posed to the patient by supplied energy or substances
ix) Protection against the risks posed to the patient for devices for self testing or administration
x) Information supplied by the manufacturer
xi) Performance evaluation including, where appropriate, clinical evaluation

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