Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
January 3, 2025
Approximately 5 minutes
Philippines Medical Device Classification: Aligning with ASEAN MDD Risk Rules
Philippines Medical Device Classification System
The Philippines medical device regulatory system is undergoing a transition toward harmonization with the ASEAN Medical Device Directive (MDD). Manufacturers must determine their device's classification to ascertain the appropriate market authorization pathway required by the Center for Device Regulation, Radiation Health and Research (CDRRHR) of the FDA.
Risk-Based Classification (Class A to D)
Medical devices are classified into four risk categories, from lowest to highest risk, primarily based on the ASEAN MDD classification rules. Key factors influencing the classification include:
- Level of Risk: Potential harm to the patient or user.
- Degree of Invasiveness: Whether the device is non-invasive, invasive, or surgically invasive.
- Delivery Method: How the device is introduced or used on the human body.
| Classification | Risk Level | Market Authorization Required |
|---|---|---|
| Class A | Lowest Risk | Certificate of Medical Device Notification (CMDN) |
| Class B | Low-Moderate Risk | Certificate of Medical Device Registration (CMDR) |
| Class C | Moderate-High Risk | Certificate of Medical Device Registration (CMDR) |
| Class D | Highest Risk | Certificate of Medical Device Registration (CMDR) |
IVD Device Classification
In Vitro Diagnostic (IVD) devices are classified separately from general medical devices but also use the four-class risk structure (Class A to D). The risk is determined by specific criteria:
- Intended Use: The purpose of the diagnostic test.
- User Expertise: The intended skill level of the user.
- Impact of Results: The importance of the resulting information and the impact of a false result (e.g., an HIV blood test is typically Class D, while a routine pregnancy test is Class B).
As the IVD risk increases, the required documentation for registration becomes more extensive.
Special Status Exemptions
Certain medical devices are exempt from the standard CMDN or CMDR requirements but still require a Medical Device Listing with the FDA. These include devices intended solely for:
- Research
- Clinical Trial
- Exhibit
- Donated and/or Novel use
Related Articles
Approximately 5 minutes
Philippines Medical Device Registration: CMDN, CMDR, and ASEAN Harmonization
The Philippines FDA (CDRRHR) uses ASEAN-harmonized Class A-D classification and two main approval routes: Certificate of Medical Device Notification (CMDN) for Class A and Certificate of Medical Device Registration (CMDR) for Classes B, C, and D. Home/Reference country approval is generally required.
Approximately 5 minutes
Philippines IVD Device Registration: Transitioning to AMDD Classification and CIVDR/CIVDN
The Philippines FDA (CDRRHR) is transitioning IVD registration to the AMDD risk classification. Registration requires a Certificate of IVD Notification (CIVDN) or Registration (CIVDR), in-country testing for high-risk classes, CSDT documentation, and authentication of legal documents by the Philippine Consulate.
Approximately 5 minutes
Philippines Medical Device Grouping: Rules for Consolidating Registration Applications
The Philippines FDA uses specific, strict rules for grouping multiple medical devices under a single registration (CMDN/CMDR) to reduce costs and streamline the process. Grouping is permitted for accessories, systems, devices with common intended use/manufacturing processes, and devices with varying materials or designs.
Approximately 5 minutes
Philippines SaMD Registration: Regulatory Framework and Technical Standards
The Philippines FDA explicitly defines Software as a Medical Device (SaMD) under AO 2018-0002, requiring risk-based registration (CMDN/CMDR). Technical documentation must comply with international standards (e.g., IEC 62304), and data privacy laws (RA 10173) must also be observed.
Approximately 5 minutes
Philippines Medical Device Labeling: Compliance with ASEAN MDD and Local Requirements
Medical device labeling in the Philippines is guided by the ASEAN MDD and is subject to FDA review. Labels must be in English and/or Filipino, contain comprehensive product and use details, and reflect the device's market authorization status (CMDN or CMDR).
Approximately 5 minutes
Philippines Medical Device Advertising: Compliance with Consumer Act and ASC Review
Medical device advertising in the Philippines is governed by the Consumer Act (RA 7394) and requires screening by the Ad Standards Council (ASC) to ensure honesty and accuracy. Sales promotions require a separate Sales Promo Permit from the FDA.
Approximately 5 minutes
Philippines Medical Device Post-Market Surveillance: Vigilance and ASEAN Alignment
Philippines FDA's Post-Market Surveillance (PMS) is transitioning towards mandatory adoption of ASEAN Vigilance guidelines (AMDD Annex 5). PMS requires local dealers to maintain traceability records, implement a complaint handling system, and manage Adverse Event (AE) reporting and Field Safety Corrective Actions (FSCA).