RMG
Regulatory
Regulatory Advisory Services
Our regulatory advisory service is designed for companies that require continuous support to ensure compliance with health regulations, both in Brazil and abroad. This includes product registration, notification, and other authorizations, as well as assistance in obtaining certifications and necessary permits for product commercialization.
Register Medical Group’s Regulatory Advisory Services:
✔ Complete management of product registration and regulatory processes, from dossier preparation to post-registration support.
✔ Regulation interpretation and application, including public consultations and updates on ANVISA and international regulatory changes, ensuring that your company remains up-to-date and compliant.
✔ Customized training for internal teams, focusing on regulations, quality practices, and applicable sanitary standards.
✔ Support in administrative processes and solutions for ANVISA’s requirements, including expert opinions and defenses when necessary.
Our advisory services take a strategic approach to ensure your company not only meets legal requirements but also optimizes processes and maximizes market competitiveness.
Healthcare Product Registration
Register Medical Group specializes in the full registration process for healthcare products, offering a comprehensive service that covers all stages required by ANVISA and other regulatory agencies. Our expert team has experience handling a wide range of products, including new and generic medicines, biological drugs , and herbal medicines.
✔ New and generic drug registration – Consultancy and support from dossier preparation to marketing authorization.
✔ Compliance for already registered medicines – Assistance with post-registration changes such as formulation, packaging, or indication modifications.
✔ Biological and herbal medicine registration – Support in conducting required tests and submitting specific documentation for each type of product.
✔ Continuous monitoring of the registration process – Assistance at every stage, including petition submission, document review , and interaction with ANVISA, including scheduling meetings and online or in-person consultations.
✔ Export and import advisory – Expertise in registering and hosting products in international markets, particularly Brazil, the U.S., Mexico , and Argentina, ensuring compliance with each country’s regulations.
Our goal is to ensure that your product complies with the stringent requirements of ANVISA, FDA, EMA, ANMAT, COFEPRIS , and other regulatory agencies, providing an efficient and transparent process.
WHY CHOOSE REGISTER MEDICAL GROUP?
✔ Experience and expertise – Our team has over 20 years of experience in the regulatory market, with expertise across various pharmaceutical and healthcare sectors.
✔ Maximization of market gains – With the right strategy, we achieve efficiency and agility in approval processes, reducing the time required to bring products to market.
✔ Strategic support – We act as partners to our clients, offering customized solutions to ensure success in the regulatory process.
✔ Personalized service – Our services are tailored to each client’s needs, focusing on speed and compliance.
✔ Commitment to compliance – Register Medical Group is dedicated to ensuring that your company meets all legal and regulatory requirements, minimizing risks and optimizing results.
Contact us to discover how we can help your company navigate the complex world of regulatory affairs for pharmaceuticals, medical devices, cosmetics, and household sanitizers.
Americas
Brazil
Main Regulations
Guideline for Implementing Good Practices in Health Products – RDC No. 16, March 28, 2013
Manual – Guide to Efficacy and Safety – Food
Manual – Registration and Registration of Medical Use Materials
Manual for Equipment Registration – Class III and IV
Manual for Submission of Clinical Development Dossier for Drugs (DDCM)
Manual for Orthopedic Implant Registration
Decree No. 8077, August 14, 2013
Regulates the conditions for the operation of companies subject to sanitary licensing, and the registration, control, and monitoring, within the scope of sanitary surveillance, of products covered by Law No. 6.360, September 23, 1976.
Resolution of the Collegiate Board – RDC No. 16, March 28, 2013 – Approves the Technical Regulation on Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products – English
Guideline for Implementing Good Practices in Health Products – RDC No. 16, March 28, 2013
Resolution – RDC 40, August 26, 2015 – Defines the requirements for the registration of medical products
Resolution RDC No. 185, October 22, 2001 – Approves the Technical Regulation included in the annex of this Resolution, which addresses the registration, alteration, revalidation, and cancellation of the registration of medical products
Resolution – RDC 36, August 26, 2015 – Addresses the risk classification, the registration control regimes, and the labeling and instructions for use requirements of in vitro diagnostic products, including their instruments
Law No. 6,437, August 20, 1977 – Establishes infractions to federal sanitary legislation and establishes the corresponding sanctions
Law No. 6,360, September 23, 1976 – Provides for the surveillance to which medicines, drugs, pharmaceutical inputs and related products, cosmetics, sanitizing agents, and other products are subject
Law No. 13,202, December 8, 2015 – Establishes the Tax Litigation Reduction Program (PRORELIT); authorizes the federal Executive Branch to adjust the value of the taxes indicated; amends Laws No. 12,873, October 24, 2013, No. 8,212, July 24, 1991, No. 8,213, July 24, 1991, No. 9,250, December 26, 1995, and No. 12,546, December 14, 2011
For more information, visit the website: www.anvisa.gov.br
Canada
Main Regulations
Canadian Medical Devices Regulations – SOR 98-282
ISO 13485 Auditing Guidelines
Guidance for Medical Device Labeling
Medical Device Associations in Canada:
Home
https://www.capra.ca/
Home
https://www.medec.org/
For more information, visit the website: https://www.hc-sc.gc.ca/index-eng.php
Colombia
Main Regulations
Decree 3275 of 2009
Decree 4725 of 2005
Resolution 004816 of 2008
For more information, visit the website: www.invima.gov.co
Costa Rica
Main Regulations
Establishment of Health Product Regulations in Costa Rica
Regulations on the registration, classification, importation, and control of medical equipment and biological materials
For more information, visit the website: https://www.ministeriodesalud.go.cr/index.php/informacion/productos-registrados
United States
Main Regulations
Industry Guidance
For more information, visit the website: www.fda.gov
Mexico
Main Regulations
General Health Law of Mexico
Health Provisions Regulations of Mexico
For more information, visit the website: www.cofepris.gob.mx
Peru
Main Regulations
Articles of Peru for the Regulation on Registration, Health Surveillance, and Control of Pharmaceutical Products, Medical Devices, and Health Products
Medical Device Regulations of Peru
For more information, visit the website: www.minsa.gob.pe
Middle East
Saudi Arabia
Main Regulations
National Provisions and Requirements for Medical Devices in Saudi Arabia
Saudi Arabia Interim Regulatory Scheme
For more information, visit the website: www.sfda.gov.sa
Egypt
Main Regulations
Decisions of the Committee on the Registration of Medical Devices, Cosmetics, Household Agrochemicals and Disinfectants (Arabic)
Medical Devices Regulations – DRAFT (Arabic)
For more information, please visit the website https://www.eda.mohealth.gov.eg/
Europe
Main Regulations
Regulation amending the European MDD 93/42 / EEC and others
European Medical Devices Directive (MDD)
Active Implantable Medical Devices European Directive (AIMDD)
European Directive on Cosmetic Products
For more information, visit the website: https://ec.europa.eu/
Israel
Main Regulations
Israeli Medical Device Guidelines (Hebrew)
Medical Equipment Law, 2012 (Hebrew)
For more information, visit the website: www.health.gov.il
South Africa
Main Regulations
Draft Regulation for Medical Devices and IVDs in South Africa
Regulations for Electromedical Devices in South Africa
South African Government Gazette – Draft Regulation
Draft Regulation South Africa Government Gazette
For more information, visit the website: https://www.mccza.com/
Asia Pacific
Australia
Main Regulations
https://www.tga.gov.au/how-therapeutic-goods-are-regulated-australia
https://www.legislation.gov.au/Details/F2010L00470
https://www.legislation.gov.au/Details/F2010L00469
Medical Device Associations in Australia:
Australian Regulatory Guidelines for Medical Devices (ARGMD)
https://www.ausbiotech.org/
https://www.adia.org.au/
https://ama.com.au/
Home
https://mtaa.org.au/
https://scienceindustry.com.au/#axzz47b8vLuaw
For more information, visit the website: https://www.tga.gov.au/
China
Main Regulations
CFDA Medical Device Regulations
Medical Device Registration Guide – CFDA
For more information, visit the website: www.sfda.gov.cn/WS01/CL0001/
India
Main Regulations
Cosmetics Regulation in India
Drugs and Cosmetics Act
Notification of Drafts Introducing Rules for Calendar M-III for Medical Devices and IVDs
For more information, visit the website: cdsco.nic.in
Hong Kong
Principais Regulamentos
Regras de classificação para os dispositivos médicos Hong Kong (PDF)
Visão geral do Medical Device Sistema de Controle Administrativo Hong Kong
Princípios de avaliação de conformidade dos dispositivos médicos Hong Kong
Para maiores informações consulte o website www.drugoffice.gov.hk
Japan
Main Regulations
Japan MHLW Ord. 136 – Quality Control Procedures for Devices
Japan MHLW Ord. 169 – SGQ Compliance
For more information, visit the website: www.pmda.go.jp
Malaysia
Main Regulations
Medical Devices in Malaysia (Exemption) – 2015
Malaysia Medical Devices Act – 2012
Malaysia Medical Device Authority Act – 2012
Malaysia Medical Device Regulations 2012
For more information, visit the website: portal.bpfk.gov.my/
New Zealand
Main Regulations
Medicines – New Zealand 1981
Medicines – New Zealand 2003
For more information, visit the website: www.medsafe.govt.nz/
Singapore
Main Regulations
Health Products (Medical Devices) Regulations – 2010
Health Products – 2007 (PDF)
For more information, visit the website: www.hsa.gov.sg/content/hsa/en.html
South Korea
Main Regulations
Enforcement Decree of the Medical Devices Act of South Korea
Enforcement Regulations of the Medical Devices Act of South Korea
For more information, visit the website: https://www.law.go.kr
Taiwan
Main Regulations
Guidelines for the Registration of Medical Devices in Taiwan
Regulations for the Management of Medical Devices in Taiwan
How to Apply for a Medical Device License in Taiwan
For more information, visit the website: www.fda.gov.tw/TC/index.aspx
MARKETS
Saudi Arabia, Argentina, Australia, Brazil, Canada, China, Colombia, Costa Rica, Egypt, United States, Europe, Hong Kong, India, Israel, Malaysia, Mexico, New Zealand, Russia, Singapore, Taiwan
MARKETS
- Audits and Quality Systems
- Regulatory Consulting and Advisory
- Product Distributors – Qualification
- Local Representation
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