Page 38 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

countries with a view improve their export potentials. However, it should
be borne in mind that not all the devices permitted for export by other
countries have been approved for commercialization in their own countries.
Therefore, there should a review of the existing certification procedures
and regulatory mechanisms in other countries. The Directorate General of
Drug Administration (DGDA) is taking steps to review the regulatory
mechanisms.

10.3.1 Definitions of Device:

 “An instrument, apparatus, implement, machine, contrivance,
implant, in vitroagent, or other similar or related article, including a
component, part or accessory,

 intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease in man, or

 intended to affect the structure or any function of the body of
man, and

 which does not achieve any of its primary intended purposes / uses

 through chemical action within or on the body of man, or by
being metabolized within the body.”

Medical devices: A medical device is defined as an inert diagnostic or
therapeutic article that does not achieve any of its principal intended
purposes through chemical action, within or on the body.

Medicated devices: These devices are treated as drugs as they contain
pharmacologically active substances. Medical devices include diagnostic
test kits, crutches, electrodes, pacemakers, arterial grafts, intra-ocular
lenses, orthopaedic pins and other orthopaedic accessories. Their purpose
varies from being used primarily for specific affected parts of the body to
being used as adjunct to primary therapies, for eg. lithotripsy with drug
therapy for kidney stone. On the basis of risks involved, the devices could
be classified as follows : -

a. Non critical devices- An investigational device that does not present
significant risk to the patients eg. Thermometer, BP apparatus.

b. Critical devices - An investigational medical device that presents a
potential serious risk to the health, safety or welfare of the
participant for example, pace markers, implants, internal catheters.

For medical devices trails, all the general principles of clinical trials
described for drug trials should be considered. Before pre market
certification, safety evaluation and pre-market efficacy of devices for 1-3
years with data on adverse reactions should be obtained. The duration of
the trial and extent of use may be decided in case-to-case basis by the

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 34