Another Reason for Manufacturers to Develop their CSDT Documentation

The Food and Drug Administration (FDA) of the Philippines released FDA Advisory 2021-3084 on November 18, 2021, providing an abridged review route for products registered by an ASEAN member’s regulatory authority under the AMDD-CSDT requirements. The Advisory comes as CMDR review times increase and more ASEAN members implement harmonized standards such as the Common Submission Dossier Template (CSDT) application format. Manufacturers will still need to submit complete CSDT documentation pursuant to Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements” but can expect quicker market access.

At this time, approvals using CSDT documentation from the following competent authorities will receive an expedited review:

• Singapore’s Health Science Authority (HSA),
• Thailand Food and Drug Administration (TFDA) approved under the new regulations implemented in February 2021,
• Malaysia Medical Device Authority (MDA),
• Indonesia’s Ministry of Health.

The route applies to Class B, C, and D products and products approved through abridged routes in. Manufacturers will need to submit a declaration of conformity stating that the submitted CSDT documents are the exact same used for the approval in the ASEAN member state being leveraged. At this time Class B, C, and D CMDRs are requiring 4-8 months for the Philippines FDA to review.

AMDD-CSDT Documentation Requirements

The ASEAN Common Submission Dossier Template (CSDT) was developed by the ASEAN Member States (AMS) to harmonize medical device applications across all member states to ease the regulatory burden for manufacturers. CSDT documentation includes:

1. Executive Summary
   1. Device Description
   2. Intended use
   3. Indications
   4. Instruction for use
   5. Storage condition
   6. Shelf life
   7. Contradictions
   8. Warnings
   9. Precautions
   10. Potential adverse Effects
   11. Alternative Therapy
   12. Materials
   13. Other Relevant specifications
   14. Other descriptive Information
2. Device Labelling
3. Detailed Manufacturer Information
4. Essential Principles of Safety and Performance of Medical Device and Method Used to demonstrate conformity
5. Summary of Design verification and validation documents
6. Risk Analysis
7. Method of destruction
8. Quality Management Certification
9. Letter of Certification of the intended use/indication/ Package, Letter of certification of label and instruction for use from manufacturer or product owners
10. Declaration of Conformity
11. Letter of Confirmation for market history proof from manufacturer
12. Letter of Safety confirmation from manufacturer
13. Proof of approval from Medical Device Regulatory Authority in Foreign Countries
14. Letter of Authorization as Distributor for Manufacturer
15. Grouping indication letter

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today to see how new regulatory developments may affect your business in the Philippines.