MDA Expands Recognition and Simplifies Verification Pathway for Medical Device Registration
Main objective of the updated guidance documents is to ensure the registration process in Malaysia is standardized and to shorten the time needed for conformity assessment. The updated guidance document applied for both medical device new registration and re-registration that has obtained a premarket approval from any recognized regulatory authorities or notified bodies.
The latest edition of guidance documents of MDA/GD/0068 and MDA/GD/0070 include the addition of two new competent regulatory authorities or notified bodies recognized by MDA. In addition, approvals from these recognized authorities that have received special authorization under specific programs or schemes are not subject to verification pathway for medical device with MDA. The newly recognized regulatory authorities are listed below:
| Countries / Regulatory Authority | Scheme / Program | Recognized Approval |
|---|---|---|
| Singapore / Health Science Authority (HSA) | Special Access Routes | Registered in the Singapore Medical Device Register (SMDR) |
| Thailand / Food and Drug Administration (FDA) | Exemptions for the manufacture or import of medical devices for non-commercial purposes, as stipulated in Section 27 of Medical Device Act. |
|
MDA has updated its guidance documents by changing the eligibility criteria for the verification pathway and updating the period of post-market surveillance and vigilance. Previously, the applicants seeking verification (initial certification) pathway were required to have been marketed for at least one year in the respective agencies' jurisdictions. This requirement has now been removed. Additionally, the period for the post market has been revised from 5 to 3 years.
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References
- 1. MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment By Way of Verification
- 2. MDA/GD/0070: Establishment Guide To Medical Registration Submission in MeDC@St Through Conformity Assessment By Way of Verification Process