This document provides guidance on the legal and technical requirements for medical device registration of Class A devices in the Philippines. It outlines that registration requires a notarized agreement from the supplier, a valid ISO 13485 quality management certificate, and a valid product registration certificate from the country of origin. It also specifies the technical documentation needed, including intended use, instructions for use, material details, specifications, conformity assessments, and labeling. Adherence to these requirements ensures medical devices meet appropriate standards for patient safety.
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Commercial medical devices in Colombia require registration with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the country’s medical device regulator. Classification of devices in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III). Colombia’s device classification system is similar to those of the European Union and other Global Harmonization Task Force (GHTF) systems. If the device falls into a lower-risk category in Colombia (Class I or IIa), the company will qualify for an automatic certificate upon notification to INVIMA —it will be able to sell its devices immediately.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
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Handling of Customer Complaint_Dr.A.AmsavelDr. Amsavel A
Reference Guideline
Definitions
GMP Requirement: 21 CFR § 211.198 and ICH Q7
Procedure for Handling of Complaints
Complaint Investigation
Remedial action and CAPA
Report preparation
Response to customer
Verification of CAPA effectiveness
Review of Complaints
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
Quality program. Certification schemes are typically written to include both the
performance test methods that the product must be tested to, as well as the criteria that
the product must meet to become Certified.
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Product certification or product qualification is the process of certifying that a certain
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processes and services (previously ISO/IEC Guide 65:1996) an international standard
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Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
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Normal defecation is painless, resulting in passage of soft, formed stool
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FECAL INCONTINENCE
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2. GOVERNING LAW
FDA CIRCULAR 2020-001
INITIAL IMPLEMENTATION OF
ADMINISTRATIVE ORDER 2018-
0002
FDA CIRCULAR 2020-001A
FINAL IMPLEMENTATON OF
ADMINISTRATIVE ORDER
2018-002
2
3. RISK CLASSIFICATION
3
ADMINISTRATIVE ORDER 2018-2002
GUIDELINES GOVERNING ISSUANCE OF AN AUTHORIZATION
FOR A MEDICAL DEVICE BASED ON THE ASEAN HARMONIZED
TECHNICAL REQUIREMENTS
6. I. NOTARIZED AGREEMENT
▰ Product being applied must be indicated.
▰ Name of Applicant
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the agreement is true/authentic and correct.
6
7. II. QMS CERTIFICATE OR ISO 13485
▰ Must be valid.
▰ Product being applied must be indicated in the
scope.
▰ Should be accompanied by notarized declaration
from the supplier/principal that the certificate is
true/authentic and correct.
7
8. III. PRODUCT REGISTRATION EQUIVALENT
▰ Must be valid.
▰ Certificate of Medical Device Notification.
▰ Certificate of Product Registration.
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the certificate is true/authentic and correct.
8
12. I. INTENDED USE
▰ Must indicate the specific use of product
being appplied.
▰ If product is part of the system, the specific
use of the product as part of the system
should be indicated and not the intended use
of the system
12
13. II. INSTRUCTION FOR USE
▰ Detailed instruction for use for the users of
the medical device.
▰ The instruction should be clear enough to
guide the users.
13
14. III. LIST OF RAW MATERIALS
▰ This should include all the raw materials as
component of the medical device itself.
14
15. IV. TECHNICAL SPECIFICATIN OF FINISHED
PRODUCT
▰ This should include the technical specification
of the finished products (physical, chemical,
mechanical, electrical, etc.). This maybe in the
form of Certificate of Analysis or Test
certificate.
15
16. V. CERTIFICATE OF CONFORMITY
▰ (Issued by government agency dealing with metrology)
on the aspect of manufacture relating to metrology for
devices with measuring functions, if applicable i.e.
Weighing Scale, etc.
▰ If not applicable, a notarized declaration should be
submitted that the product being applied for has no
measuring function
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.
16
17. VI. DECLARATION OF CONFORMITY
(MANUFACTURERS SELF DECLRATION)
▰ These are the standards used during the design,
development, manufacture, testing of the medical
devices.
▰ The standards to be considered are Philippine National
Standards (PNS), international standards (ISO, IEC) and
other equivalent national standards (of these
international standards
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.
17
18. VII. ARTWORK AND LABELING MATERIALS
▰ Clear colored pictures of labels from all sides.
▰ Immediate label, secondary packaging, box label and
package insert/brochure, whichever is applicable.
▰ For any additional product claims on the label, submit
studies or tests supporting the claims.
▰ For imported products, if the brand name is the
product’s local brand, declaration from the
manufacturer allowing use of the brand name and IPO
approval of the said brand name.
18
19. VII. SHELF-LIFE
▰ For product with shelf-life, submit stability studies to
support the claim.
▰ For product without shelf-life, submit a notarized
declaration/ certification that the product has no shelf-
life and therefor not covered by the requirement. This
must be accompanied by notarized declaration that the
declaration/ certification is true and correct.
19
21. 21
▰ If a CE marking is reflected on the label, submit valid
certificate supporting the placement of the CE mark.
▰ Pictures and text of the label should be clear and will
not be pixelated when the view is increase in size.
▰ Lot No., Batch No., Serial No., whichever is applicable
should be reflected
▰ Storage condition, sterilization method should be
reflected if applicable.
▰ Importer and distributor’s name and address should be
reflected in the label of the product together with the
Registration No.