Medical Device Regulations
Quality system requirements
A Quality System is defined as the organizational structure, responsibilities,
procedures, processes and resources needed to implement quality management.
Quality system standards are “generic management standards” and are described in
The international quality system
standards for medical devices are issued by the International Organization for
Standardization (ISO) (ISO13485:1996 and ISO13488: 1996). ISO13485:1996 includes
all the elements of ISO9001:1994 plus a set of minimum supplementary
requirements for medical devices. The relationship between ISO9001:1994 and
ISO13485:1996 is described in Annex 3. ISO13488:1996 is the same as ISO13485:
1994, but without the design control requirements. A new standard,
ISO13485:200?, is currently being developed and will become the international
reference standard for medical devices.
Regulations for quality systems
may cover the methods, facilities and controls used by the manufacturer in the
design, manufacture, packaging, labelling, storage, installation, servicing and
post-market handling of medical devices. Therefore, quality system requirements
can influence all phases in the medical device life span. Applicable
requirements depend upon the risk class of the device and on the regulatory
system of the country.
Design control is normally not required for regulatory scrutiny in medium- to
When applied to the manufacturing process, quality system requirements impose
strict quality assurance on every aspect of production. The result is a tightly
controlled manufacturing system, commonly known as Good Manufacturing Practice (GMP),
which reduces the likelihood of non-conforming products. This practice ensures
consistency in the quality and provides the basis for greater reliability in
device safety and performance. Elements of the quality system are periodically
subject to audits, management review, and corrective or preventive actions that
will maintain product quality. Continuous monitoring and corrective action
requirements are interrelated to post-market surveillance previously described.
The key advantage regarding quality systems is that they represent a preventive
approach to assuring medical device quality versus the previous reactive
approach by inspection and rejection at the end of the manufacturing line.
Prevention has been proven to be more efficient and cost effective in
controlling manufacturing processes and maintaining medical device quality.
It is important to note that since the majority of medical devices are in the
medium- to low-risk classes, their compliance with regulations often depends
upon the declarations of manufacturers, thus the question of quality assurance
naturally arises. This is why it is critical for manufacturers to conform with
quality system standards and for this conformity to be subject to periodic audit
by governmental or third party agencies.
All founding members of the GHTF have quality system requirements for their
manufacturers, who are subject to periodic inspection by the government and/or
accredited third party agencies. The applicable standard is determined by the
risk class of the device and depends upon the regulatory system of the country
Table 3. Quality system
standards used by different authorities
|COUNTRY / REGION
||STANDARDS / REGULATIONS
||ISO13485 or EN46001*
ISO13488 or EN46002*
|Government and Third party
||Union EN46001* or ISO13485
EN46002* or ISO13488
||GMP #40 ordinance
GMPI #63 ordinance
QS Standard for medical
devices #1128 notice
||QS (21 CFR part 820)
*EN46001 and EN46002 are being
phased out by the end of March 2004.
With the rapid growth in the
global market for medical devices, there is a need to harmonize national
standards in order to minimize regulatory barriers and to facilitate trade.
Harmonization also reduces the cost of local industry and government
The next chapter summarizes the work of the Global Harmonization Task Force to
find common elements and ways to unify the different national standards and
( Report By : (WORLD HEALTH ORGANIZATION , GENEVA )