2. Standardization on Medical Devices
Deepak Aggarwal
Scientist E (Medical Equipment and Hospital Planning Dept.)
Bureau of Indian Standards
14th December 2018

3. About BIS
Bureau of Indian Standards (BIS), the National Standards Body of India
Brief History
Set up on 6 January 1947 as Indian Standards Institution for promoting harmonious development of the activities of
standardization
marking and quality certification of products and services
Bureau of Indian standards (BIS) is governed by BIS Act 2016 under Department of Consumer Affairs, Government of India with various objectives including :-
providing safe reliable quality goods;
minimizing health hazards to consumers;
promoting exports and imports substitute;
control over proliferation of varieties etc. through standardization, certification and testing.
Through this change over, the government envisaged building a climate for quality culture and consciousness and greater participation of consumers in formulation and implementation of national standards.

4. Our Presence BIS Head Quarter New Delhi 05 Regional Offices (ROs)
Kolkata (Eastern),
Chennai (Southern),
Mumbai (Western),
Chandigarh (Northern)
Delhi (Central).
34 Branch offices
8 Laboratories (BIS)
200 Recognized OSL
Training Institute at Noida

5. BIS Activities
In the interest of consumers as well as the industry, BIS is involved in various activities as given below: 
Standards Formulation
Product Certification Scheme
Compulsory Registration Scheme
Foreign Manufacturers Certification Scheme
Hall Marking Scheme
Laboratory Services
Laboratory Recognition Scheme
Sale of Indian Standards
Consumer Affairs Activities
Promotional Activities
Training Services, National & International level

6. Benefits of Standards in Promoting Quality
Fitness for Purpose
Compatibility
Interchangeability
Variety Control
Safety
Protection of the Environment
Product Protection
(ISO GUIDE 2)

7. Medical Equipment and Hospital Planning Department (MHD)
Setting National Standards on Medical Devices
19 sectional committees,
1200 plus Indian Standards encompass product specifications in various branches of medicine
Standardization – A dynamic process
Involvement of stakeholders – Manufacturers, clinicians and patients, regulators, health care providers, testing Laboratories - through consensus principle
Harmonization with International Standards – ISO/IEC
facilitating global trade and thus rendering the new technology accessible and affordable

8. National Standards on Medical Devices

9. BIS Standards formulation activity in last few months
BIS has conducted a series of meetings during the last 4-5 months with following stakeholders for identification of gap areas:
1) Experts/Doctors
2) Medical Device Manufacturing industries (Manufacturers/Importers)
3) Association of Indian Manufacturers of Medical Devices (AiMED)
4) Association of Diagnostic Instruments Manufacturers of India (ADMI)
5) Medical Technologists Association of India (MTaI)
6) Drug Controller General of India
7) Deptt of Pharmacy Govt of India
8) Department of Biotechnology, Govt of India (BIRAC)
9) Meetings with Medical Device ‘Startup’ Industry in association with DHR (ICMR)
10) HITES Limited
Based on the discussions with the above stakeholders, gap areas have been identified and process of standard formulation are being expedited by BIS through a ‘core group’.
Process of standard development Jul Aug Sep Oct Nov
Standards sent into
wide circulation
Standards sent for printing
Standards Published

10. Collaborative approach with stakeholders
All stakeholders should implement standards in their day-to-day use for bringing quality in their respective applications.
Active participation of all stakeholders in standard formulation process enables upgradation of standards from time to time.
New items for standardization can be proposed by the Stakeholders on BIS website.
Conformity Assessment schemes of BIS ensure quality products and effective implementation of Standards.

11. Recommendations for National Governments
Strengthen existing harmonization/alignment process through synchronized efforts of stakeholders including regulatory agencies.
Boost local/regional production of medical devices based on specific national requirements conforming to national standards.
Setting up state of the art laboratories for conformity assessment of medical devices.
Strengthen the use of existing National Standards through regulatory framework and push for their strict compliance in licensing and certification process thus ensuring quality products reaching the customer

12. Recommendations for WHO/International Organizations
Identification of gap area and a focused approach for standardization requirements in health sector pertaining to developing countries
Standards can be a complementary tool in the efforts of WHO for promoting quality ecosystem of medical devices especially in the developing countries
WHO should continue to provide such platforms for uniformity of implementation of the latest & globally acceptable guidelines on medical devices.
WHO should consider enhancing their promotional activities in developing nations to encourage compliance and reduce the burden of enforcement to curb the menace of substandard medical devices.
Thank
You