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INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India. As seen in previous Notifications, the CDSCO is expected to release guidance of risk classification and generic intended use for ultrasound equipment.

Manufacturers and importers of these devices will need to obtain an Import Licenses (Form MD-15) under the Medical Device Rules, 2017 to maintain market access. Products without valid license may not be imported and marketed after November 1, 2020.

Suggested actions:

  • Identify any devices in your portfolio that utilize ultrasound technology
  • Confirm if the intended use matches those listed in the CDSCO guidance document (when available)
  • Prepare for application submission for applicable devices no later than January 1, 2020 to ensure licenses are in place by November 1, 2020

The mandate was published in the Gazette of India on October 16th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.The resolution to regulate ultrasound equipment was originally raised 21 months earlier at the February 12th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.  

INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019

The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019.  (reference LKPP No. 5265/D.2.2/05/2019)

Initial guidance from LKPP was that no new e-Catalogue applications would be accepted this year. However, in response to industry feedback, new e-Catalogue listing applications may be accepted on a limited basis under the following conditions:

  • Companies with interest in making application for a new e-Catalogue listing, must submit an application to the Ministry of Health (MoH) by this Friday, June 21. The MoH will then select among applicants and submit a list of device categories for new registrations to the LKPP this year. 
  • Medical device manufacturers with interest in new e-Catalogue listings should coordinate quickly with the holder of their Import Licenses (AKL) to make application this week to the MoH.  It is also advisable to begin assembly of the full LKPP e-Catalogue enrollment application as certain documents require Authentication from the Indonesian Embassy in the country of origin, which can take several weeks. 

The Ministry of Health applications requires the following documents (submitted in soft-copy on USB stick):

  1. Application letter with a list of products of interest (templates provided by MoH) (reference MOH No. KN.01.01/I.4/5945/2019)
  2. Original scan of importers Distribution License (IPAK)
  3. Original scan of product Import License (AKL)
  4. Product brochure, leaflet, and information 

The LKPP application intake will commence in July, followed shortly by price negotiation meetings with new e-Catalogue listings targeted for October.

Asia Actual is available to answer questions. Contact us to arrange an initial conversation.