HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

Increased regulatory status of breast implants from Notified to Licensed (Class 4) will increase cost and time required to obtain an Import License.

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

Increased regulatory status of breast implants from Notified to Licensed (Class 4) will increase cost and time required to obtain an Import License.

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

INDIA POSTPONES REGISTRATION DEADLINES FOR MOST NEWLY NOTIFIED MEDICAL DEVICES

As a result, medical device manufacturers now have 12 months before a Form MD-15 (Import License) will be required for the devices to clear Indian Customs. With government review guidance at 6 to 9 months, applications should be prepared for submission no later than March 1st, 2020 to safely avoid losing market access.

INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

On October 18th, 2019 the Ministry of Health and Family Welfare published a draft of the Medical Device Rules, 2019 as a proposed amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over a 42-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2019 will come into full effect after being approved and published in the official gazette. The draft notification allows 30 days from 18 October 2019 for public comment and stakeholder feedback.

The plan calls for an 18-month voluntary registration period after which all class A and B devices would have 16 months to be registered (i.e., by Sep 17, 2022) in the CDSCO’s on-line portal. Class C and D devices would have 24 months to meet the same requirement (i.e., by May 17, 2023).

The registration application involves administrative documents such a Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The registration process carries no government processing fees and do not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for an Import License (upon Notification). Once registered the local license holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India. 

Further, the registration process will generate a registration number which the importer must mention on the label of the medical device prior to placing the devices on the market (i.e., after Customs clearance).

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES

The Thai FDA has amended the Medical Device Act, 2009, and Medical Device Ordinance, 2018 (as amended) to add a Concise Evaluation option for qualifying Notified and Licensed medical and IVD devices. The new evaluation process eliminates the requirement for a Fee Sales Certificate / Certificate to Foreign Government issued from the country of origin. Guidance was published on September 30, 2019 with immediate effect. 

QUALIFICATION

To qualify for Concise Evaluation, a medical device must be registered (through full evaluation) and marketed for more than one year without any serious adverse events in 2 of 5 reference markets listed below; or in 1 of the markets for at least three years.

  1. Australia: Therapeutic Good Administration (TGA)
  2. Canada: Health Canada (HC)
  3. European Union:  Notified Body (EU NB)
  4. Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
  5. USA: Food and Drug Administration (FDA)
NEW DOCUMENT LIST

In addition to the same documents required for a Full Evaluation, the following additional documents are required for the Concise Evaluation:

  1. Market Approval from regulatory authority in reference countries
  2. Marketing History Declaration
  3. Manufacturer Safety Declaration to confirm no reported deaths, serious deterioration in the state of health, open field safety corrective actions (recalls) at the point of submission of the application
  4. Declaration Letter that Device Quality; intended use, indication packaging, labeling, instructions for use for supply in Thailand are identical as that approved by the reference agency.
  5. Letter of Certification conformity to Concise Evaluation

For IVD devices, the products must also be included on the World Health Organization’s (WHO) list of pre-qualified IVD products (list available here).

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

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 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.