Guidelines for Medical Device Authorization

Provide guidelines on documentary requirements for medical device registration
Align Philippine registration requirements with ASEAN Medical Device Directive via CSDT

Covers all medical devices intended for sale, import, export, manufacture, and use in the Philippines
Excludes in-vitro diagnostic and refurbished devices (covered separately)

Applicant: Individual/entity applying for authorization
Authorization: Certification of compliance issued by CDRRHR
CDRRHR: Regulatory office of FDA handling medical devices
CMDN: Certificate for Class A devices (Notification)
CMDR: Certificate for Class B, C, D devices (Registration)
CMDL: Certificate for devices for research, trials, exhibits, donation
CSDT: ASEAN harmonized technical requirements
Country of Origin: Manufacturing or prior approval country
Distributor/Importer/Exporter/Wholesaler: Establishments handling medical device distribution
In-Vitro Diagnostic Device: Devices for examination of human specimens
Legal Manufacturer: Responsible entity for device design/manufacture
License to Operate: FDA-issued authorization for operations
Manufacturer: Entity involved in production process
Medical Device: Instruments/apparatus intended for diagnosis, treatment, or supporting life, etc., excluding pharmacological means
Medical Device System: Device composed of essential components
Notification: Authorization for Class A devices
Product Owner: Entity supplying device under own name, responsible for product tasks
Product Standards: Standards recognized by DOH
Refurbished Device: Previously owned reconditioned medical device
Registration: Approval for B-D class device marketing/use
Trader: Entity owning product, subcontracting manufacture

Classification by risk: Class A (Low), B (Low-Moderate), C (Moderate-High), D (High)
Applicants to classify based on issued lists or ASEAN classification rules
CDRRHR to verify and possibly reclassify devices
Class A devices require Notification; Classes B-D require Registration
CMDN and CMDR are valid for 5 years, renewable every 5 years
Distributors must notify CDRRHR within 30 days if device production/distribution stops
Approved registrations published on FDA website
Devices for research, trials, exhibits, donation require CMDL, exempt from Notification/Registration
Additional documentary requirements may be requested
Disapproved applications returned; unclaimed documents discarded after 90 days

Separate application per device except allowed aggregated filings with separate certificates
Registration fee for combined applications equals total fees for individual products

Deficiencies must be corrected within 90 days or application disapproved
Applicants may re-apply within 60 days after disapproval
Product labels must include importer/distributor names and CMDN/CMDR numbers
Documentary requirements detailed in annexes according to class
Application evaluation within 180 days; non-compliance leads to disapproval
Renewal applications accepted 90 days prior to expiry; late renewals fined
Renewals submitted later than 120 days post expiry treated as new applications
Renewal evaluation within 30 days; deficiencies must be corrected within 30 days
CMDL applications filed before importation

Initial coverage includes existing registrable products and class A notifications
Lists by classification to be released by CDRRHR
Phased implementation for registration requirement expansion

Effective 15 days after publication in two newspapers and filing with UP ONAR
Medical device registration under new requirements implemented one year post-effectivity
Voluntary early application submission permitted by CDRRHR