12 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Medical Device Regulations: A Global Perspective
In 1992, the medical device regulation project was included
in the State Council’s legislative plan.
In 1993, the State Pharmaceutical Administration submitted
the first draft to the State Council.
In 1994, the State Pharmaceutical Administration established
the Department of Medical Device Administrative Supervision.
By then, China had preliminarily completed the preparatory work
for implementing unified management of medical devices.
After the initial draft was submitted to the State Council,
the council’s Legislative Affairs Office deliberated whether the
management measures and the proposed management system
outlined were suitable for China’s national conditions and practi-
cally feasible, as there were no precedents to follow. It was deemed
inappropriate to issue State Council regulations at that time.
Instead, it was considered more appropriate to first issue them in
the form of departmental regulations by the State Pharmaceutical
Administration.
In 1996, the State Pharmaceutical Administration issued the
Interim Provisions for Clinical Trials of Medical Device Products
and the Administrative Measures for the Registration of Medical
Device Products (the Measures).
The Measures stipulated that starting 1 January 1997, “any
medical device product entering the Chinese market must be
registered with the Chinese government’s medical device admin-
istrative supervision and management department by the product
manufacturer or their authorized representative.”
In 1998, with the continuous deepening of reform and
opening up, the State Council carried out government institutional
reforms. It abolished the State Pharmaceutical Administration,
which was responsible for industry management, and established
the State Drug Administration (SDA), focusing on market
supervision, thereby creating a modern drug (including medical
devices) supervision and management system. At the same time,
the Legislative Affairs Office of the State Council restarted the
work on formulating medical device regulations.
After the establishment of the SDA, while continuing to
implement the medical device registration system based on the
Measures, the SDA redrafted the regulatory articles, taking into
account the effects, experiences, and issues identified following the
implementation of the Measures. By retaining the basic framework
of the original registration system and improving aspects such as
postmarket supervision, it resubmitted the draft to the Legislative
Affairs Office of the State Council.
In January 2000, the State Council issued the Regulations,
which officially came into effect on 1 April 2000. This was the first
set of medical device supervision and management regulations
issued at the State Council level in China.71
This marked a new phase in the legalization of medical device
supervision and management in China, signifying the progress
of China’s medical device market towards standardization and
order. With the Regulations as the superior law, SDA revised and
improved the Measures, reissued the Provisions for the Regis-
tration of Medical Devices, and formulated and issued depart-
mental regulations such as the Provisions for the Supervision and
Management of Medical Device Manufacturing Enterprises and
the Provisions for the Supervision and Management of Medical
Device Distribution Enterprises.
On 18 March 2021, the State Council of China announced
newly revised Regulations, marking another significant milestone
in the history of medical device regulation in China.
The newly revised Regulations introduced features to en-
courage innovation and development. They specify that the state
will formulate industrial planning and policies for medical devices,
prioritize medical device innovation as a key development focus,
give priority to the review and approval of innovative medical de-
vices, support the clinical promotion and use of innovative medical
devices, and promote the high-quality development of the medical
device industry.
The revised Regulations also address risk management across
the entire product lifecycle, in a fashion similar to the essential
principles outlined by IMDRF.
On 8 September 2023, the Standing Committee of the 14th
National People’s Congress included the Medical Device Manage-
ment Law in its legislative planning projects. The National Med-
ical Products Administration has established a leadership team,
working groups, and expert advisory groups to begin drafting the
relevant legal texts.73
Latin America (LATAM) and the Caribbean
Brazil
Brazil operates under a federal republic system, blending features
of both a federal state and a republic. In this framework, Brazil
functions as a federation of states with a republican governance
structure. The central government, headquartered in Brasília, holds
authority over the entire nation, while individual states retain
autonomy to govern their internal affairs. This division of power
between the central government and states aims to maintain a
balance, fostering both national unity and regional diversity. To
ensure effective governance, the Brazilian government is structured
into three branches—mirroring the classic separation of powers—
comprising the executive, legislative, and judicial branches. A basic
primer of Brazil’s federal government system, while out of the
scope of this book, is useful in this context.74
The Development of Medical Device Regulation. Brazil’s Na-
tional Institute of Metrology, Quality, and Technology (INMET-
RO) This organization plays a role in ensuring the safety, quality,
and competitiveness of products in the Brazilian market. Estab-
lished in 1973, INMETRO oversees standardization, metrology,
and certification processes across various industries, including
healthcare. Specifically related to medical devices, INMETRO
accredits testing laboratories, establishes technical standards, and
conducts conformity assessments to verify compliance with regula-
tory requirements. By ensuring that medical devices meet rigorous
quality and safety standards, INMETRO promotes consumer
safety, facilitates market access, and enhances Brazil’s position in
the global medical device industry.75
Fundamentals of Medical Device Regulations: A Global Perspective
In 1992, the medical device regulation project was included
in the State Council’s legislative plan.
In 1993, the State Pharmaceutical Administration submitted
the first draft to the State Council.
In 1994, the State Pharmaceutical Administration established
the Department of Medical Device Administrative Supervision.
By then, China had preliminarily completed the preparatory work
for implementing unified management of medical devices.
After the initial draft was submitted to the State Council,
the council’s Legislative Affairs Office deliberated whether the
management measures and the proposed management system
outlined were suitable for China’s national conditions and practi-
cally feasible, as there were no precedents to follow. It was deemed
inappropriate to issue State Council regulations at that time.
Instead, it was considered more appropriate to first issue them in
the form of departmental regulations by the State Pharmaceutical
Administration.
In 1996, the State Pharmaceutical Administration issued the
Interim Provisions for Clinical Trials of Medical Device Products
and the Administrative Measures for the Registration of Medical
Device Products (the Measures).
The Measures stipulated that starting 1 January 1997, “any
medical device product entering the Chinese market must be
registered with the Chinese government’s medical device admin-
istrative supervision and management department by the product
manufacturer or their authorized representative.”
In 1998, with the continuous deepening of reform and
opening up, the State Council carried out government institutional
reforms. It abolished the State Pharmaceutical Administration,
which was responsible for industry management, and established
the State Drug Administration (SDA), focusing on market
supervision, thereby creating a modern drug (including medical
devices) supervision and management system. At the same time,
the Legislative Affairs Office of the State Council restarted the
work on formulating medical device regulations.
After the establishment of the SDA, while continuing to
implement the medical device registration system based on the
Measures, the SDA redrafted the regulatory articles, taking into
account the effects, experiences, and issues identified following the
implementation of the Measures. By retaining the basic framework
of the original registration system and improving aspects such as
postmarket supervision, it resubmitted the draft to the Legislative
Affairs Office of the State Council.
In January 2000, the State Council issued the Regulations,
which officially came into effect on 1 April 2000. This was the first
set of medical device supervision and management regulations
issued at the State Council level in China.71
This marked a new phase in the legalization of medical device
supervision and management in China, signifying the progress
of China’s medical device market towards standardization and
order. With the Regulations as the superior law, SDA revised and
improved the Measures, reissued the Provisions for the Regis-
tration of Medical Devices, and formulated and issued depart-
mental regulations such as the Provisions for the Supervision and
Management of Medical Device Manufacturing Enterprises and
the Provisions for the Supervision and Management of Medical
Device Distribution Enterprises.
On 18 March 2021, the State Council of China announced
newly revised Regulations, marking another significant milestone
in the history of medical device regulation in China.
The newly revised Regulations introduced features to en-
courage innovation and development. They specify that the state
will formulate industrial planning and policies for medical devices,
prioritize medical device innovation as a key development focus,
give priority to the review and approval of innovative medical de-
vices, support the clinical promotion and use of innovative medical
devices, and promote the high-quality development of the medical
device industry.
The revised Regulations also address risk management across
the entire product lifecycle, in a fashion similar to the essential
principles outlined by IMDRF.
On 8 September 2023, the Standing Committee of the 14th
National People’s Congress included the Medical Device Manage-
ment Law in its legislative planning projects. The National Med-
ical Products Administration has established a leadership team,
working groups, and expert advisory groups to begin drafting the
relevant legal texts.73
Latin America (LATAM) and the Caribbean
Brazil
Brazil operates under a federal republic system, blending features
of both a federal state and a republic. In this framework, Brazil
functions as a federation of states with a republican governance
structure. The central government, headquartered in Brasília, holds
authority over the entire nation, while individual states retain
autonomy to govern their internal affairs. This division of power
between the central government and states aims to maintain a
balance, fostering both national unity and regional diversity. To
ensure effective governance, the Brazilian government is structured
into three branches—mirroring the classic separation of powers—
comprising the executive, legislative, and judicial branches. A basic
primer of Brazil’s federal government system, while out of the
scope of this book, is useful in this context.74
The Development of Medical Device Regulation. Brazil’s Na-
tional Institute of Metrology, Quality, and Technology (INMET-
RO) This organization plays a role in ensuring the safety, quality,
and competitiveness of products in the Brazilian market. Estab-
lished in 1973, INMETRO oversees standardization, metrology,
and certification processes across various industries, including
healthcare. Specifically related to medical devices, INMETRO
accredits testing laboratories, establishes technical standards, and
conducts conformity assessments to verify compliance with regula-
tory requirements. By ensuring that medical devices meet rigorous
quality and safety standards, INMETRO promotes consumer
safety, facilitates market access, and enhances Brazil’s position in
the global medical device industry.75