MDSAP Issued Certificates
| Certificate number | Revision Number | Expiration Date | Description | Standard | Status |
|---|---|---|---|---|---|
| NCC 22.09287 | Rev.04 | 17/06/2025 | Scope: Design and development, manufacturing, sales, post-sales of dental products, diamond burs, carbide burs, polishers, dental strips and dental in... Scope: Design and development, manufacturing, sales, post-sales of dental products, diamond burs, carbide burs, polishers, dental strips and dental instruments Not applicable items: 7.5.3: Installation activities 7.5.4: Servicing activities 7.5.9.2: Particular requirements to implantable medical devices 8.3.4: Rework. Leia mais | Standard: ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 - Full Quality Assurance System Brazil: ... Standard: ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) Japan PMD Act (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |
| NCC 22.09319 | Rev.04 | 24/06/2025 | Scope: "Design, development, manufacturing, marketing and distribution of disposable sterile instrumental and surgical kits and reprocessed non-s... Scope: "Design, development, manufacturing, marketing and distribution of disposable sterile instrumental and surgical kits and reprocessed non-sterile instrumental and surgical kits, used in otorhinolaryngology, orthopedics and neurosurgery surgeries, orthopedic equipment and sterile surgical electrodes for neurosurgery and orthopedics" Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 22.09498 | Rev.02 | 13/09/2025 | Scope: Design, Development, Manufacture and Distribution of CranioMaxilloFacial Orthopedic Implants, Spine, Extremities (hand and foot), thoracic and ... Scope: Design, Development, Manufacture and Distribution of CranioMaxilloFacial Orthopedic Implants, Spine, Extremities (hand and foot), thoracic and Surgical Instruments. Distribution and Technical Assistance of Piezoelectric Motor. Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 22.09554 | Rev.04 | 06/10/2025 | Scope: Design, Development and Production of medical devices for endoscopy, gastrostomy and urology | ISO 13485:2016 Brazil: RDC ANVISA no. 665/2022 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subpa... ISO 13485:2016 Brazil: RDC ANVISA no. 665/2022 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |
| NCC 22.09627 | Rev.01 | 04/11/2025 | Scope: “Design, Manufacture, Sale and Distribution of Surgical Instruments, External Fixators, Consumable Materials and non-active sterile and non-ste... Scope: “Design, Manufacture, Sale and Distribution of Surgical Instruments, External Fixators, Consumable Materials and non-active sterile and non-sterile Implantable Products for: hip, knee and shoulder arthroplasty, craniomaxillofacial osteosynthesis, extremities and traumatology, spine and sports medicine.” Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº 67/2009 | Ativo |
| NCC 22.09723 | Rev.02 | 16/12/2025 | Scope: "Design, development, manufacturing, distribution, marketing and after-sales support of medical devices, specifically defibrillators/cardi... Scope: "Design, development, manufacturing, distribution, marketing and after-sales support of medical devices, specifically defibrillators/cardioverters and multiparameter monitors" Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 23.09766 | Rev.00 | 06/01/2026 | Scope: Design, Development, Production, and Service of Silicone Gel Filled Breast Implants, Silicone Facial Subcutaneous Implants, Tissue Expander for... Scope: Design, Development, Production, and Service of Silicone Gel Filled Breast Implants, Silicone Facial Subcutaneous Implants, Tissue Expander for Single Use, Medical Silicone Gel Sheet, Nostril Retaine. Leia mais |
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 |
Suspenso |
| NCC 23.09995 | Rev.03 | 28/04/2026 |
Scope: Scope: “Design, manufacturing, sales and distribution of medical and dental products: metallic components – Dentfix, surgical instrument... Scope: Scope: “Design, manufacturing, sales and distribution of medical and dental products: metallic components – Dentfix, surgical instruments, no-articulated sharp instruments to micro and mini fragments, no-articulated sharp instruments, Diamond burs – Medicalfix, instruments – Medicalfix, articulated no-sharp instruments – Medicalfix, Diamond ultrasound tips, plate base, surgical kit – Dentfix, metallic components to implants – Dentfix, prosthetic components in polymers, surgical blades – Medicalfix, healer – Dentfix, tips with TIN recovering ultrasound – Medicalfix, polymeric components to implants – Dentfix, dental implants with superficial treatment, orthodontic screws, micro and mini fragments straight plate – Medicalfix, micro and mini fragments screws – Medicalfix, Titanium components – Dentfix, locking rigid fixation system – Medicalfix and Medicalfix 2.4, cranial closure system – Medicalfix, templates – Medicalfix, palatal distractor – Traumafix, micro and mini fragments special plates – Medicalfix.” Leia mais |
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 23.10044 | Rev.03 | 25/05/2026 | Scope: “Design, manufacture and distribution of sterile dental implants, sterile and non-sterile prosthetic components and non-sterile surgical instru... Scope: “Design, manufacture and distribution of sterile dental implants, sterile and non-sterile prosthetic components and non-sterile surgical instruments” Leia mais | ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) – Full Quality Assurance Syst... ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) – Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022, RDC ANVISA nº 551/2021, RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) Japan PMD Act (as applicable) USA: 21 CFR Part 803 – Medical Device Reporting / 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) – Establishment Registration and Device Listing 21 CFR Part 820 – Quality System Regulation / 21 CFR Part 821 – Device Tracking Leia mais Esconder | Ativo |
| NCC 23.10094 | Rev.01 | 15/06/2026 |
“Scope: Design, development, manufacturing, sales and distribution of: – Non-sterile implants for osteotomy and traumatology (upper and lower l... “Scope: Design, development, manufacturing, sales and distribution of: – Non-sterile implants for osteotomy and traumatology (upper and lower limbs) and cranio-maxillofacial; – Non-sterile reusable surgical instruments for osteotomy, traumatology (upper and lower limbs) support and craniomaxillofacial. – Sterile disposable surgical instruments (ETO) with coated for: craniomaxillofacial, upper and lower limbs coated with diamond and/or DLC, craniomaxillofacial for traumatology, arthroplasty and maxillofacial coated by DLC Black or Diamond; – Sterile surgical instruments (ETO) for surgical support on osteotomy, traumatology (upper and lower limbs) and craniomaxillofacial; – Disposable temporomandibular joint (ETO); – Sterile implants (ETO) with applicator (disposable) with wire and anchor for reconstruction of soft tissue; – Sterile implants (ETO) with disposable applicator Button, wire and plate for fixation of fragments on syndesmotic fractures; – Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of anterior cruciate ligament. – Sterile prothesis (ETO) for arthroplasty of partial elbow; – Sterile implants (ETO) for fixation of various bone fractures.” Leia mais |
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 23.10153 | Rev.02 | 31/07/2026 | Scope: “Design and development, manufacturing, exportation, distribution and servicing activities provided by the organization for electromedical equi... Scope: “Design and development, manufacturing, exportation, distribution and servicing activities provided by the organization for electromedical equipment as optoelectronic, ultrasonic, radiofrequency or resistive dedicated to medical, aesthetic, helping to diagnosis or therapeutic use" Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 23.10460 | Rev.02 | 29/12/2026 | Scope: Design, manufacture, distribution, sales and technical assistance services of medical devices for cryolipolysis, radiofrequency, ultrasound, el... Scope: Design, manufacture, distribution, sales and technical assistance services of medical devices for cryolipolysis, radiofrequency, ultrasound, electromagnetic stimulation, laser equipment, air abrasion aesthetics system, therapeutic massager, cooling device for dermatological treatments and camera for capturing images of the skin for dermatology. Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 / RDC ANVISA nº 551/2021 / RDC ANVISA nº 67/2009 USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR ... ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 / RDC ANVISA nº 551/2021 / RDC ANVISA nº 67/2009 USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking Leia mais Esconder | Ativo |
| NCC 24.10597 | Rev.03 | 19/03/2027 | Scope: ‘’Design, development, manufacturing, after-sales of products for cardiopulmonary use. Import, commercialization and after-sales of products fo... Scope: ‘’Design, development, manufacturing, after-sales of products for cardiopulmonary use. Import, commercialization and after-sales of products for cardiopulmonary use and implantable neuromodulation devices and servicing of extracorporeal blood treatment equipments for the area of cardiovascular" Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part... ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking Leia mais Esconder | Ativo |
| NCC 24.10663 | Rev.02 | 17/04/2027 | Scope: Design, development, manufacture, sales, distribution, and technical assistance of the following products: – Automatic pressurized pen for meso... Scope: Design, development, manufacture, sales, distribution, and technical assistance of the following products: – Automatic pressurized pen for mesotherapy, intradermotherapy and drug injection; – Electric pen for microneedling; – High-power focused micro and macro ultrasound equipment; – Microcontrolled laser equipment; – High-power micro and macro focused ultrasound equipment with radiofrequency microneedling; – Laser emission therapy equipment; Import and distribution of sterile health products for mesotherapy, intradermotherapy and microneedling Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10742 | Rev.01 | 29/05/2027 | Scope: “Design, manufacture, package and distribution of Mard-Flex (Bipolar Electrode)” | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 24.10781 | Rev.02 | 11/06/2027 | Scope: "Manufacture, import, export, distribution, design, installation, technical assistance, training and rental of electromedical and medical-... Scope: "Manufacture, import, export, distribution, design, installation, technical assistance, training and rental of electromedical and medical-hospital devices in the neurosurgery and general surgery areas, including their consumables (sterile and non-sterile) and the development of software related to the healthcare area". Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 24.10933 | Rev.01 | 19/08/2027 | Scope: “Design, manufacture, storage and distribution of solution for hypothermic storage of organ intended to transplantation | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 | Ativo |
| NCC 24.10965 | Rev.01 | 03/09/2027 | Scope: "Design, Manufacture, Distribution, Sales, Installation and Service of Machine Raw Material for Medical Devices Industry Scope Particulari... Scope: "Design, Manufacture, Distribution, Sales, Installation and Service of Machine Raw Material for Medical Devices Industry Scope Particularity: Dental Chairs, Dental Delivery Units, Dental Light, Dental Water Units, Vaccum Pumps, Compressors, Dental Scanner” Not applicable items: 7.5.5 – Particular Requirements for Sterile Medical Devices 7.5.9.2 – Particular Requirements for Implantable Medical Devices Leia mais | ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 – Full Quality Assurance System Brazil: RDC ANVISA... ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 – Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) USA: 21 CFR Part 803 – Medical Device Reporting 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) – Establishment Registration and Device Listing 21 CFR Part 820 – Quality System Regulation Leia mais Esconder | Ativo |
| NCC 24.11011 | Rev.01 | 26/09/2027 | Scope: Scope: Design and development, manufacturing, sales and technical service of respiratory mechanics monitors and accessories | ISO 13485:2016 Brazil: RDC ANVISA no. 665/2022 Medical Device Reporting 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subpart... ISO 13485:2016 Brazil: RDC ANVISA no. 665/2022 Medical Device Reporting 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) – Establishment Registration and Device Listing 21 CFR Part 820 – Quality System Regulation Leia mais Esconder | Ativo |
| NCC 24.11186 | Rev.01 | 25/12/2027 | Scope: Design, development, manufacturing, sales, distribution, installation and technical assistance of dental office, clinical chairs and tables, re... Scope: Design, development, manufacturing, sales, distribution, installation and technical assistance of dental office, clinical chairs and tables, reflectors and dental X-ray. Distribution of handpieces of high and low rotation, dental electrical, electronics and pneumatic motors, curing light, dental ultrasonic and compressors. Leia mais | ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance Syst... ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Schedule 3, Part 4 - Production Quality Assurance Procedures Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |
| NCC 25.11305 | Rev.01 | 02/08/2025 | Scope: Design, development, manufacture and service of surgical laser systems, laser skin surface treatment systems and light skin surface treatment s... Scope: Design, development, manufacture and service of surgical laser systems, laser skin surface treatment systems and light skin surface treatment systems for the area of dermatology. Leia mais | ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance Syst... ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance SystemBrazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) Japan PMD Act (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |
| NCC 25.11311 | Rev.01 | 10/03/2028 | Scope: Design, development, manufacture, distribution, sale and export of: Standard (non-customized) implantable medical devices, customized medical d... Scope: Design, development, manufacture, distribution, sale and export of: Standard (non-customized) implantable medical devices, customized medical devices, sterile and non-sterile, in general, for craniomaxillofacial reconstruction, arthroplasty and fixation surgery; Customized “overdenture” devices for fixation of maxillary and mandibular prosthesis; Customized sterile and non-sterile instrumental devices for guiding the cutting, drilling and positioning of craniomaxillofacial implants; Standard (non- customized) non-sterile instrumental devices for guiding the cutting, drilling and positioning of temporomandibular joint implants; Sterile and non-sterile instrumental devices for craniomaxillofacial surgery; Customized silicone molds for manufacturing Polymethyl methacrylate (PMMA) implants; Orthopedic devices, including instruments and fixators.Import, distribution and sale of: electromedical equipment, including radiofrequency therapy equipment and its accessories; pulse lavage equipment for use in surgery; imaging equipment for intraoral scanning; in-vitro diagnostic products, including rapid test kits for qualitative detection of COVID and Influenza. Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 25.11325 | Rev.01 | 13/03/2028 | Design, development, manufacturing, importing, sales and post-marketing supporting of monitoring and diagnostic medical devices”. | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Me... ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |
| NCC 25.11339 | Rev.01 | 20/03/2028 | Scope: Design, development, manufacture and distribution of sterile products such as cannulas, surgical lavage systems, nerve stimulators and probes, ... Scope: Design, development, manufacture and distribution of sterile products such as cannulas, surgical lavage systems, nerve stimulators and probes, trocars and irrigation and fluid aspiration systems. In this way, the solutions developed meet general, endoscopic and laparoscopic surgical procedures in the areas of orthopedics, regenerative medicine and dentistry. Leia mais | ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 | Ativo |
| NCC 25.11414 | Rev.00 | 15/04/2028 | Scope: "Design, development, import, export, distribution, sales and manufacture of Adhesive Tapes, Sterile absorbent wound dressing with or with... Scope: "Design, development, import, export, distribution, sales and manufacture of Adhesive Tapes, Sterile absorbent wound dressing with or without antimicrobial agent, sterile and non-sterile adhesive absorbent wound dressing with or without antimicrobial agent, Compression and support bandages, Sterile and non-sterile hydrogel wound dressing with or without antimicrobial agent, amorphous gel with and without antimicrobial agent, Silicone gel for scars hyper-oxygenated fatty acid products, Hydro-active colloid paste, Sterile and non-sterile hydrocolloid wound dressing with or without antimicrobial agent, Sterile and non-sterile Cold sore & Acne patches, foot care plasters, Sterile foam wound dressing with or without antimicrobial agent, Sterile soft silicone polyurethane foam dressings with or without Antimicrobial agent, Lipocolloid dressings, Antimicrobial Lipocolloid dressings, Sterile non-adherent wound contact layer with or without antimicrobial agent, paraffin gauze dressings, antimicrobial paraffin gauze dressings, sterile saline wipes, alcohol swabs and alcohol free swabs, sterile alginate wound dressing with or without antimicrobial agent, with or without Carbon, Hydrofibers dressing with or without antimicrobial agent, sterile theater incise drapes with or without antimicrobial agent, sterile skin closure strips, sterile catheter securement dressing with or without antimicrobial agent, Thermoregulating Pad, Bandages with Zinc Oxide paste, disposable protective clothing and face masks, the provision of ethylene oxide sterilization for single use medical devices as part of contact manufacturing” Leia mais | ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance Syst... ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation Leia mais Esconder | Ativo |