Your Update On Medical Device Regulations – Brazil & India
Global Improvements In Regulations
Medical device regulations continue to change due to many factors including globalization, technological improvements, and even global pandemics, and this has led to improvements in medical device regulations worldwide.
Our expert team examines the latest medical device updates in Brazil and India for 2022.
Medical Devices Updates In India
In this regard, earlier this year, India has proposed a new Draft Law which will enable the medical device sector to be appropriately regulated and allow for continued growth in the sector.
This is important given recent projections for India’s share in the global medical devices industry to increase from $11 billion to $50 billion in the next 8 years.
In July 2022, India’s Ministry of Health and Family Welfare published the draft Law, which aims to replace the existing Drugs and Cosmetics Act of 1940, and ensure safety and efficacy of all drugs, cosmetics and medical devices sold in India.
The Draft Law provides for several new definitions including ‘investigational medical device’ and ‘clinical trial’. Importantly, it ensures medical devices will be managed as a distinct category from drugs.
The draft also includes provisions relating to the creation of a medical device technical advisory board, and the operation of medical device testing facilities at state and federal level.
It also establishes requirements for obtaining permission to carry out clinical studies.
Moreover, it provides a mechanism to regulate online sale or distribution of medical devices.
Furthermore, the manufacture and import of medical devices that do not meet the prescribed standards will be prohibited.
Overall, the Drugs, Medical Devices and Cosmetics Bill takes into account modern-day technological and medicinal breakthroughs and is a positive step forward.
Further clarity is required on certain aspects like medical device reporting, and may be provided before the Central Government finalizes the bill.
Medical Devices Updates In Brazil
In the face of technological advances, Brazil has also updated its regulation of medical devices.
In this regard, Resolution (RDC) 687/2022 was published in May 2022 to replace Resolution RDC No. 183/2017 to provide the criteria for granting or renewal, of Good Manufacturing Practice Certification of medical devices, which is important for manufacturers who want to import, export or commercialize medical devices in Brazil.
The Resolution focuses on several objectives including defining forms of certification, simplification of the list of documents to be submitted for renewal of existing certifications, and disclosure of the risk matrix used by the Brazilian Health Regulatory Agency, ANVISA, in the certification process, in order to give more transparency to the process and predictability to the manufacturer sector.
In September 2022, ANVISA published Resolution RDC No. 751/2022 which replaces Resolution RDC No. 185/2021, and establishes rules for risk classification of medical devices, requirements for labeling and instructions for use (IFU), and procedures for notification or registration of medical devices.
The goals of the Resolution include regulation and classification of new products on the market that were not regulated or defined by the old standard, details on IFU formatting rules, and consolidation of notification and registration rules.
This resolution will enter into force on 1 March 2023.
Stay Compliant With Global Medical Devices Regulations
Catch up on our latest medical device updates with your coffee here:
- IVD Regulations In The EU
- IVDR Regulatory Compliance: What are your IVDR and product blindspots?
- IVDR Compliance: What You Need To Know
- Regulatory Developments in Medical Devices: A Review of Recent Legislation
- Medical Device Industry 2022 Regulatory Update Webinar
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