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India Considering New Device Regulations

As you can see, this is a rather encumbering list of “deliverables”. As you probably guessed, it is rather advantageous to have an Indian company represent you when going through this process…an insider, if you will.

Inspections of Foreign Manufacturing Facilities

Like ANVISA (See “Passing Brazil’s Inspections to Take Product to Market,” BONEZONE January 2013), CDSCO has recently begun inspections of manufacturing facilities in foreign countries, such as Italy, to help ensure the quality of medical devices imported into India. Once initial pilot projects are successful, the CDSCO will introduce auditing and inspection of manufacturing in more countries in the near future. It is purported that these inspections will be closely aligned with ISO 13485, and the Indian Government will most likely charge the interested medical device manufacturer to inspect the Quality Management System, e.g. in the U.S., Canada, Italy, Japan, etc.

New Proposed Medical Devices Regulation Bill

In 2006, the Medical Devices Regulation Bill (MDRB) was proposed by the Ministry of Science and Technology. The MDRB was designed to consolidate laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). This proposal was geared toward establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. The bill was intended to be fully implemented by December 31, 2009 as a Parliament Act. However, it was not passed by India’s Council of States and was subsequently abolished. Recently, though, there has been talk of reintroducing the MDRB in late 2013 or early 2014.

If enacted, the MDRB will oversee all medical devices throughout India. Companies that want to sell devices in India or manufacture products locally (for sale in India) will have to comply with the design, manufacturing, packaging, labeling, import, sale, use and disposal requirements of the MDRB. The bill will increase the list of products requiring medical device registration in India, as well.

Proposed Classification System for Medical Devices

If the MDRB is implemented, a risk classification system for medical devices will be set up comprising Classes A, B, C and D. This classification is consistent with the definition and guidance from the Global Harmonization Task Force (GHTF), as well as the European Union (EU) medical device directives.

  Class  

  Risk Level

  Device Examples

  A

  Low Risk

  Thermometers/Tongue Depressors

  B

  Low Moderate Risk  

  Hypodermic Needles/Suction Equipment       

  C

  Moderate High Risk  

  Lung Ventilators/Bone Fixation Plates

  D

  High Risk

  Heart Valves/Implantable Defibrillators    

 

Influences on Regulatory Structure Development

India has not modeled its regulatory system after FDA. The Indians consider the approach to the cGMP-Quality System Regulation too costly to apply in India and too complex for Indian industry to adopt without many questions to answer and cultural adjustments to abide by. India is leaning more toward a European-type approach to regulations. For reasons of cost and existing infrastructure, India is attracted to the flexibility of the EU’s structure with its reliance on a de-centralized network of private sector conformity assessment bodies appointed by the Competent Authority of each member state, e.g. the European Union.

Use of Notified Bodies

India will consider the use of private third-party conformity assessment bodies (referred to as “Notified Bodies” and similar to Notified Bodies under the European Union or EU medical device directives) to carry out conformity assessments. They would assess medical device manufacturing sites on the basis of the ISO 13485 quality management system standard and submit findings to the regulatory authority (CDSCO or CDA) to make a decision on granting a manufacturing license. This would apply to medical device classes IIa, IIb and III (B, C, D above).

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