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INDONESIA ENFORCES MEDICAL DEVICE LABELING REQUIREMENTS

The new medical device regulations (Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods.) that went into effect on January 12, 2018 include the requirement that the Instruction for Use (IFU) including intended use, contraindications, attentions, and warnings be translated into the local language (Bahasa Indonesia) (ref. Paragraph 41, Clause 6). Implementation of this requirement was to be given a two year grace period (e.g., through January 12, 2020).

However, the Ministry of Health has been requesting the IFU in Bahasa Indonesia starting in March of this year as a supplemental document request for registration applications.  As such, it is recommended that all new device registration applications include the IFU in local language.

At this point, devices with valid registration certificates (AKL) previously issued without IFU in local language, may continue to be imported and sold into the Indonesian market.  Any future amendment to the AKL should include addition of the IFU in Indonesian language. Device manufacturers should still check with their Indonesia license holder for any active AKL certificates to confirm the IFU requirements individually.

Classification of Medical Device

International ClassificationExamplesRisk Level
ACholesterol, uric acid test system
Surgical Instrument; Bandage
Surgical camera; Electric operating table
Patient scale
Low
BPregnancy self testing
Electric Hospital Bed
Surgical Lamp, Surgical Mask
Low – Moderate
CBlood glucose self testing
ECG, X-ray Unit, Syringe
Condom, Contact lens
High – Moderate
DHIV Blood donor screening, Stent
Intraocular lens (IOL), Defibrillator, Pacemaker
High

Asia Actual has a local, licensed office in Jakarta to provide medical device registration, license holding, importing and commercial support services in Indonesia. Please contact us with any questions or support requests.

PHILIPPINES FDA CHANGES IMPLEMENTATION PLAN FOR NEW MEDICAL DEVICE REGULATIONS

The FDA hosted a meeting on September 19th in Manila at which a revised implementation strategy for the new medical device regulations (Administrative Order 2018-0002) was rolled out. Significant changes were made to the original implementation plan announced back on February 22 to simplify and streamline transition to the new Rules.

 
Under the new plan, Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) will require a Certificate of Medical Device Registration (CMDR) by November 3, 2019.  Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that Certificates of Product Registration (CPR) issued under the current Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021.
  1. Notified medical devices will be re-classified according to AMDD risk classification
  2. Validity of initial CMDN & CMDR will be 5 years
  3. A single application for a medical device system, family or multiple manufacturing sites is allowed (manual submission only), but will generate multiple CMDR/N
  4. Government processing fee for initial CMDN/CMDR application is PhP7,500 (about US$150)
  5. All Medical Devices and IVD that are not included in the scope of initial implementation shall be considered non-regulated products; importers License to Operate (LTO) may be provided for customs clearance in lieu of a COE.
  6. Technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT)
  7. Administrative data requirements include:
    • Letter of authorization copy with Notarized Declaration Letter of Authenticity
    • ISO 13485 copy with Notarized Declaration Letter of Authenticity
    • Requirement for Certificate of Free Sales (CFS) has been eliminated
    • Copy of registration in country of origin with Notarized Declaration Letter of Authenticity
    • Color picture of the device from all sides

The FDA will release written guidelines to make these changes official.

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.